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Sponsor R & D Strategy Adjustment
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The main purpose of this study is to evaluate the efficacy of SHR-1210 plus Apatinib versus AMD plus IFO in participants with soft tissue sarcoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1210 plus Apatinib | Experimental |
| |
| ADM plus IFO or IFO alone | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1210 plus Apatinib | Drug | SHR-1210 200 mg q3w+ Apatinib 500 mg qd |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | Randomization to Radiographic Progression or Death Due to Any Cause (Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions) | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 31 months, CT was conducted at baseline、weeks 7、13、19 and then every 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Baseline to documented disease Remission to study discontinuation, Partial Remission is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 30% decrease in the sum of the beaseline diameter of target lesions. | From date of randomization until the date of study completion, an average of 1 year, CT was conducted at baseline、weeks 7、13、19 and then every 12 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yang Yao, M.D. | Shanghai Jiao Tong University Affiliated Sixth People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Jiao Tong University Affiliated Sixth People's Hospital | Shanghai | Shanghai Municipality | China |
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| ID | Title | Description |
|---|---|---|
| FG000 | SHR-1210 Plus Apatinib | SHR-1210 200 mg q3w+ Apatinib 500 mg qd |
| FG001 | ADM Plus IFO or IFO Alone | ADM 60 mg/m2 D1 + IFO 2 g/m2 D1-D4 q3w;if the cumulative doses of ADM were beyond 450 mg/m2, the monotherapy of IFO (2 g/m2 D1-D5 q3w) would be used. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SHR-1210 Plus Apatinib | SHR-1210 200 mg q3w+ Apatinib 500 mg qd |
| BG001 | ADM Plus IFO or IFO Alone | ADM 60 mg/m2 D1 + IFO 2 g/m2 D1-D4 q3w;if the cumulative doses of ADM were beyond 450 mg/m2, the monotherapy of IFO (2 g/m2 D1-D5 q3w) would be used. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Progression Free Survival (PFS) | Randomization to Radiographic Progression or Death Due to Any Cause (Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions) | Posted | Median | 95% Confidence Interval | months | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 31 months, CT was conducted at baseline、weeks 7、13、19 and then every 12 weeks. |
|
18 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
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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 | SHR-1210 Plus Apatinib | SHR-1210 200 mg q3w+ Apatinib 500 mg qd | 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drug-induced liver injury | Hepatobiliary disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Project manager | Jiangsu HengRui Pharmaceuticals Co., Ltd. | +86-18036618962 | qianna.zhan@hengrui.com |
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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 25, 2019 | Jul 13, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 23, 2020 | Jul 13, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| C553458 | apatinib |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| ADM plus IFO or IFO alone | Drug | ADM 60 mg/m2 D1 + IFO 2 g/m2 D1-D4 q3w;if the cumulative doses of ADM were beyond 450 mg/m2, the monotherapy of IFO (2 g/m2 D1-D5 q3w) would be used. |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
ADM 60 mg/m2 D1 + IFO 2 g/m2 D1-D4 q3w;if the cumulative doses of ADM were beyond 450 mg/m2, the monotherapy of IFO (2 g/m2 D1-D5 q3w) would be used.
|
|
| Secondary | Objective Response Rate (ORR) | Baseline to documented disease Remission to study discontinuation, Partial Remission is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 30% decrease in the sum of the beaseline diameter of target lesions. | Posted | Number | participants | From date of randomization until the date of study completion, an average of 1 year, CT was conducted at baseline、weeks 7、13、19 and then every 12 weeks. |
|
|
|
| 50 |
| 27 |
| 50 |
| 50 |
| 50 |
| EG001 | ADM Plus IFO or IFO Alone | ADM 60 mg/m2 D1 + IFO 2 g/m2 D1-D4 q3w;if the cumulative doses of ADM were beyond 450 mg/m2, the monotherapy of IFO (2 g/m2 D1-D5 q3w) would be used. | 2 | 47 | 13 | 47 | 45 | 47 |
| Liver injury | Hepatobiliary disorders | Systematic Assessment |
|
| Immune-mediated hepatitis | Hepatobiliary disorders | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | Systematic Assessment |
|
| White blood cell count decreased | Investigations | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | Systematic Assessment |
|
| Platelet count decreased | Investigations | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | Systematic Assessment |
|
| Pyrexia | General disorders | Systematic Assessment |
|
| Impaired healing | General disorders | Systematic Assessment |
|
| Hernia | General disorders | Systematic Assessment |
|
| Infection | Infections and infestations | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Septic shock | Infections and infestations | Systematic Assessment |
|
| Wound infection | Infections and infestations | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Immune-mediated enterocolitis | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Gastrointestinal disorders | Gastrointestinal disorders | Systematic Assessment |
|
| Pathological fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Tumor lysis syndrome | Metabolism and nutrition disorders | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hemoptysis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Cytokine release syndrome | Immune system disorders | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | Systematic Assessment |
|
| Nephrotic syndrome | Renal and urinary disorders | Systematic Assessment |
|
| Cor Pulmonale | Cardiac disorders | Systematic Assessment |
|
| Degenerative aortic valve disease | Cardiac disorders | Systematic Assessment |
|
| Hypotension | Vascular disorders | Systematic Assessment |
|
| Immune thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Myelosuppression | Blood and lymphatic system disorders | Systematic Assessment |
|
| Coagulopathy | Blood and lymphatic system disorders | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | Systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | Systematic Assessment |
|
| Gingival pain | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | Systematic Assessment |
|
| Asthenia | General disorders | Systematic Assessment |
|
| Pyrexia | General disorders | Systematic Assessment |
|
| Chest discomfort | General disorders | Systematic Assessment |
|
| Chest pain | General disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Oedema peripheral | General disorders | Systematic Assessment |
|
| Reactive capillary endothelial proliferation | Immune system disorders | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
|
| White blood cell count decreased | Investigations | Systematic Assessment |
|
| Platelet count decreased | Investigations | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | Systematic Assessment |
|
| Weight decreased | Investigations | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | Systematic Assessment |
|
| Blood thyroid stimulating hormone increased | Investigations | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | Systematic Assessment |
|
| Bilirubin conjugated increased | Investigations | Systematic Assessment |
|
| Blood bilirubin unconjugated increased | Investigations | Systematic Assessment |
|
| Electrocardiogram T wave abnormal | Investigations | Systematic Assessment |
|
| Total bile acids increased | Investigations | Systematic Assessment |
|
| Blood albumin decreased | Investigations | Systematic Assessment |
|
| Red blood cells urine positive | Investigations | Systematic Assessment |
|
| Blood creatine phosphokinase MB increased | Investigations | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | Systematic Assessment |
|
| Blood pressure increased | Investigations | Systematic Assessment |
|
| Blood uric acid increased | Investigations | Systematic Assessment |
|
| Fibrin D dimer increased | Investigations | Systematic Assessment |
|
| Occult blood positive | Investigations | Systematic Assessment |
|
| Urinary occult blood positive | Investigations | Systematic Assessment |
|
| Alpha hydroxybutyrate dehydrogenase increased | Investigations | Systematic Assessment |
|
| Blood creatinine increased | Investigations | Systematic Assessment |
|
| Blood fibrinogen increased | Investigations | Systematic Assessment |
|
| C-reactive protein increased | Investigations | Systematic Assessment |
|
| Interleukin level increased | Investigations | Systematic Assessment |
|
| Mitochondrial aspartate aminotransferase increased | Investigations | Systematic Assessment |
|
| Neutrophil count increased | Investigations | Systematic Assessment |
|
| Tri-iodothyronine free decreased | Investigations | Systematic Assessment |
|
| White blood cell count increased | Investigations | Systematic Assessment |
|
| Protein urine present | Investigations | Systematic Assessment |
|
| Red blood cell count decreased | Investigations | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypochloraemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypoproteinaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Laryngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Pigmentation disorder | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hypertension | Vascular disorders | Systematic Assessment |
|
| Hypotension | Vascular disorders | Systematic Assessment |
|
All clinical study findings and documents will be regarded as confidential. The investigator and members of his/her research team must not disclose such information without prior written approval from the sponsor.