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This is a phase II, multicenter, randomized, open-label study designed to evaluate the efficacy and safety of perioperative trastuzumab+XELOX with / without atezolizumab in participants eligible for surgery with locally advanced HER2-positive gastric cancer or adenocarcinoma of GEJ.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Atezolizumab plus Trastuzumab with XELOX (Capecitabine + Oxaliplatin) | Experimental | Participants will receive atezolizumab + trastuzumab + XELOX (Capecitabine + Oxaliplatin) for 3 treatment cycles prior to surgery, each cycle is 3 weeks. Following surgery, patrticipants will receive 5 further cycles of this regimen. |
|
| Arm B: Trastuzumab with XELOX (Capecitabine + Oxaliplatin) | Active Comparator | Participants will receive trastuzumab + XELOX (Capecitabine + Oxaliplatin) for 3 treatment cycles prior to surgery, each cycle is 3 weeks. Following surgery, participants will receive 5 further cycles of this regimen. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atezolizumab | Drug | Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle for 3 cycles prior to surgery and 5 cycles after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological Complete Regression (pCR) Rate | pCR is defined as no evidence of vital residual tumor cells on hematoxylin and eosin evaluation of the complete resected gastric/GEJ specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (NAST), which will be reviewed by local pathologist.. | Completion of neoadjuvant systemic therapy (up to approximately 16 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Event-free Survival (EFS) | Event-free survival (EFS), defined as the time from randomization to the first documented disease recurrence, unequivocal tumor progression determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurs first. | Randomization to the first documented disease recurrence, unequivocal tumor progression or death from any cause, whichever occurs first (up to approximately 52 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | 100142 | China | |||
| West China Hospital, Sichuan University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40244574 | Derived | Peng Z, Zhang X, Liang H, Zheng Z, Wang Z, Liu H, Hu J, Sun Y, Zhang Y, Yan H, Tong L, Xu J, Ji J, Shen L. Atezolizumab and Trastuzumab Plus Chemotherapy for ERBB2-Positive Locally Advanced Resectable Gastric Cancer: A Randomized Clinical Trial. JAMA Oncol. 2025 Jun 1;11(6):619-624. doi: 10.1001/jamaoncol.2025.0522. | |
| 35623069 | Derived |
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For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A: Atezolizumab Plus Trastuzumab With XELOX (Capecitabine + Oxaliplatin) | Participants received atezolizumab + trastuzumab + XELOX (Capecitabine + Oxaliplatin) for 3 treatment cycles prior to surgery, each cycle is 3 weeks. Following surgery, participants received 5 further cycles of this regimen. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 22, 2024 | Mar 11, 2024 |
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| Trastuzumab | Drug | Trastuzumab will be administered as an 8 mg/kg IV loading dose and then 6 mg/kg IV on Day 1 of a 21-day cycle for 3 cycles before surgery, and administration will continue after surgery. The first administration of trastuzumab after surgery should also be given at the loading dose of 8 mg/kg. |
|
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| Capecitabine | Drug | Capecitabine 1000 mg/m^2 will be administered twice orally on Days 1-14, repeated every 3 weeks. |
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| Oxaliplatin | Drug | Oxaliplatin 130 mg/m^2 will be administered by IV on Day 1 of a 21-day cycle. |
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| Disease-Free Survival (DFS) | Disease-free survival (DFS), defined as the time from surgery to the first documented disease recurrence or death from any cause, whichever occurs first. | Surgery to first documented disease recurrence or death from any cause, whichever occurs first (up to approximately 52 months) |
| Overall Survival (OS) | Overall survival (OS), defined as the time from randomization to death from any cause in all patients. | Randomiation to death from any cause (up to approximately 52 months) |
| Major Pathologic Response (MPR) | Major pathologic response (MPR), defined as < 10% residual tumor per tumor bed based on evaluation of the resected primary esophagogastric specimen by a local pathologist. | Randomization up to approximately 16 months |
| Objective Response Rate (ORR) | Objective response rate (ORR), defined as the proportion of patients with a complete response (CR) or partial response (PR) during NAST, as determined by the investigator according to RECIST v1.1. | Randomiation to CR or PR during neoadjuvant systemic therapy (up to approximately 16 months) |
| R0 Resection Rate | R0 resection rate, defined as the proportion of patients with a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed and/or sampled regional lymph nodes based on evaluation by the local pathologist. | Surgery |
| Percentage of Participants With Adverse Events | Baseline through the end of study (approximately 52 months) |
| Chengdu |
| 610041 |
| China |
| Nanfang Hospital, Southern Medical University | Guangzhou | 510515 | China |
| Harbin Medical University Cancer Hospital | Harbin | 150081 | China |
| Zhongshan Hospital Fudan University | Shanghai | 200032 | China |
| Liaoning Provincial Cancer Hospital | Shengyang | 110042 | China |
| First Hospital of China Medical University | Shenyang | 110001 | China |
| Tianjin Medical University Cancer Institute & Hospital | Tianjing | 300060 | China |
| Chang X, Ge X, Zhang Y, Xue X. The current management and biomarkers of immunotherapy in advanced gastric cancer. Medicine (Baltimore). 2022 May 27;101(21):e29304. doi: 10.1097/MD.0000000000029304. |
| Arm B: Trastuzumab With XELOX (Capecitabine + Oxaliplatin) |
Participants received trastuzumab + XELOX (Capecitabine + Oxaliplatin) for 3 treatment cycles prior to surgery, each cycle is 3 weeks. Following surgery, participants received 5 further cycles of this regimen. |
| COMPLETED |
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| NOT COMPLETED |
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Intention-to-treat Population is defined as all participants who were randomly assigned to a treatment, regardless of whether they had surgery.
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A: Atezolizumab Plus Trastuzumab With XELOX (Capecitabine + Oxaliplatin) | Participants received atezolizumab + trastuzumab + XELOX (Capecitabine + Oxaliplatin) for 3 treatment cycles prior to surgery, each cycle is 3 weeks. Following surgery, participants received 5 further cycles of this regimen. |
| BG001 | Arm B: Trastuzumab With XELOX (Capecitabine + Oxaliplatin) | Participants received trastuzumab + XELOX (Capecitabine + Oxaliplatin) for 3 treatment cycles prior to surgery, each cycle is 3 weeks. Following surgery, participants received 5 further cycles of this regimen. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pathological Complete Regression (pCR) Rate | pCR is defined as no evidence of vital residual tumor cells on hematoxylin and eosin evaluation of the complete resected gastric/GEJ specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (NAST), which will be reviewed by local pathologist.. | Intention-to-treat (ITT) population, defined as all participants who were randomly assigned to a treatment, regardless of whether they had surgery. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Completion of neoadjuvant systemic therapy (up to approximately 16 months) |
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| Secondary | Event-free Survival (EFS) | Event-free survival (EFS), defined as the time from randomization to the first documented disease recurrence, unequivocal tumor progression determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurs first. | Not Posted | Aug 2027 | Randomization to the first documented disease recurrence, unequivocal tumor progression or death from any cause, whichever occurs first (up to approximately 52 months) | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Disease-Free Survival (DFS) | Disease-free survival (DFS), defined as the time from surgery to the first documented disease recurrence or death from any cause, whichever occurs first. | Not Posted | Aug 2027 | Surgery to first documented disease recurrence or death from any cause, whichever occurs first (up to approximately 52 months) | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Overall survival (OS), defined as the time from randomization to death from any cause in all patients. | Not Posted | Aug 2027 | Randomiation to death from any cause (up to approximately 52 months) | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Major Pathologic Response (MPR) | Major pathologic response (MPR), defined as < 10% residual tumor per tumor bed based on evaluation of the resected primary esophagogastric specimen by a local pathologist. | Not Posted | Aug 2027 | Randomization up to approximately 16 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) | Objective response rate (ORR), defined as the proportion of patients with a complete response (CR) or partial response (PR) during NAST, as determined by the investigator according to RECIST v1.1. | Intention-to-treat (ITT) population, defined as all participants who were randomly assigned to a treatment, regardless of whether they had surgery. | Posted | Number | 95% Confidence Interval | Percentage of participants | Randomiation to CR or PR during neoadjuvant systemic therapy (up to approximately 16 months) |
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| Secondary | R0 Resection Rate | R0 resection rate, defined as the proportion of patients with a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed and/or sampled regional lymph nodes based on evaluation by the local pathologist. | Intention-to-treat (ITT) population, defined as all participants who were randomly assigned to a treatment, regardless of whether they had surgery. | Posted | Number | 95% Confidence Interval | Percentage of particpants | Surgery |
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| Secondary | Percentage of Participants With Adverse Events | Not Posted | Aug 2027 | Baseline through the end of study (approximately 52 months) | Participants |
From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious & other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm A: Atezolizumab Plus Trastuzumab With XELOX (Capecitabine + Oxaliplatin) | Participants received atezolizumab + trastuzumab + XELOX (Capecitabine + Oxaliplatin) for 3 treatment cycles prior to surgery, each cycle is 3 weeks. Following surgery, participants received 5 further cycles of this regimen. | 2 | 21 | 0 | 21 | 6 | 21 |
| EG001 | Arm B: Trastuzumab With XELOX (Capecitabine + Oxaliplatin) | Participants received trastuzumab + XELOX (Capecitabine + Oxaliplatin) for 3 treatment cycles prior to surgery, each cycle is 3 weeks. Following surgery, participants received 5 further cycles of this regimen. | 0 | 21 | 0 | 21 | 5 | 21 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Gingival bleeding | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Platelet count decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Bilirubin conjugated increased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Blood bilirubin unconjugated increased 2 | Investigations | MedDRA 26.1 | Systematic Assessment |
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| White blood cell count decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Amylase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Blood albumin decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Blood glucose increased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Blood thyroid stimulating hormone increased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Blood urea increased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Haemoglobin decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Neutrophil count increased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| PCO2 decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| PO2 decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Protein total decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| White blood cell count increased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Blood lactate dehydrogenase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Heart rate decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Lymphocyte count decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Weight increased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
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| Leukocytosis | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 26.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 26.1 | Systematic Assessment |
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| Chills | General disorders | MedDRA 26.1 | Systematic Assessment |
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| Face oedema | General disorders | MedDRA 26.1 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 26.1 | Systematic Assessment |
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| Malaise | General disorders | MedDRA 26.1 | Systematic Assessment |
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| Peripheral swelling | General disorders | MedDRA 26.1 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
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| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
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| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
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| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
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| Coronary artery disease | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
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| Sinus arrhythmia | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| Post procedural infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| Wound complication | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
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| Incision site pain | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
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| Taste disorder | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
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| Anaesthesia | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
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| Hyperthyroidism | Endocrine disorders | MedDRA 26.1 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
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| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
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| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
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| Proteinuria | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
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| Protein total decreased | Investigations | MedDRA 26.1 | Non-systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 26.1 | Non-systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 26.1 | Non-systematic Assessment |
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| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 26.1 | Non-systematic Assessment |
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The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | genentech@druginfo.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 16, 2023 | Mar 11, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000594389 | atezolizumab |
| D000068878 | Trastuzumab |
| D000069287 | Capecitabine |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Participants |
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| Participants |
|
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