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| Name | Class |
|---|---|
| NanJing PLA 81 Hospital | OTHER |
| Fudan University | OTHER |
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Nimotuzumab is a humanized monoclonal antibody against epidermal growth factor receptor (EGFR). Clinical trials are ongoing globally to evaluate Nimotuzumab in different indications. Nimotuzumab has been approved to treat squamous cell carcinoma of head and neck (SCCHN), glioma and nasopharyngeal carcinoma in different countries.The clinical phase Ⅲ trial designed to assess overall survival(OS)of the combination of Nimotuzumab administered concurrently with Gemcitabine in patients with RAS wild type of locally advanced or metastatic pancreatic cancer
Nimotuzumab is a humanized monoclonal antibody against epidermal growth factor receptor (EGFR). Clinical trials are ongoing globally to evaluate Nimotuzumab in different indications. Nimotuzumab has been approved to treat squamous cell carcinoma of head and neck (SCCHN), glioma and nasopharyngeal carcinoma in different countries.The clinical phase Ⅲ trial designed to assess overall survival(OS)of the combination of Nimotuzumab administered concurrently with Gemcitabine in patients with RAS wild type of locally advanced or metastatic pancreatic cancer.Secondary objectives include time to progression(TTP),progression-free survival(PFS),Objective Response Rate(ORR),Disease Control Rate(DCR),Clinical Benefit Response(CBR)and safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nimotuzumab and Gemcitabine | Experimental | nimotuzumab,400mg/w,Intravenous infusion over 60 minutes,Until disease progression or intolerable toxicity or subjects ask to leave the test. Gemcitabine,1000mg/m2,Intravenous infusion over 30 minutes,Once every three weeks, rest one week (d1,8,15; q28d), Every 4 weeks for a period,Until disease progression or intolerable toxicity or subjects ask to leave the test. |
|
| Placebo and Gemcitabine | Placebo Comparator | placebo,400mg/w,Intravenous infusion over 60 minutes,Until disease progression or intolerable toxicity or subjects ask to leave the test. Gemcitabine,1000mg/m2,Intravenous infusion over 30 minutes,Once every three weeks, rest one week (d1,8,15; q28d), Every 4 weeks for a period,Until disease progression or intolerable toxicity or subjects ask to leave the test. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nimotuzumab | Drug | nimotuzumab,400mg/w,Intravenous infusion over 60 minutes,Until disease progression or intolerable toxicity or subjects ask to leave the test. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival(OS) | The primary endpoint was overall survival (OS, defined as from randomization to death due to any cause). We screened 90 pts (90 patients were allocated for treatment) from 480 pts, of whom 8 pts were excluded due to serious violation of the inclusion criteria: 7 pts with K-Ras mutants, 1 pt with gallbladder cancer. Finally, 82 pts were included in FAS. The primary end point was evaluated in the full analysis set (FAS; all eligible patients who received at least one dose of nimotuzumab/placebo and had one evaluation of efficacy). | up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Progression(TTP) | TTP, defined as from randomization to the first observation of disease progression. 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. | up to 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| shukui qin, MD, PHD | 81th Hospital of PLA | Principal Investigator |
| jin li, MD, PHD | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Bengbu Medical College | Bengbu | Anhui | 233004 | China | ||
| Second Affiliated Hospital of Anhui Medical University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37647576 | Derived | Qin S, Li J, Bai Y, Wang Z, Chen Z, Xu R, Xu J, Zhang H, Chen J, Yuan Y, Liu T, Yang L, Zhong H, Chen D, Shen L, Hao C, Fu D, Cheng Y, Yang J, Wang Q, Qin B, Pan H, Zhang J, Bai X, Zheng Q. Nimotuzumab Plus Gemcitabine for K-Ras Wild-Type Locally Advanced or Metastatic Pancreatic Cancer. J Clin Oncol. 2023 Nov 20;41(33):5163-5173. doi: 10.1200/JCO.22.02630. Epub 2023 Aug 30. |
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We screened 480 patients between April 10, 2015, and September 2020, at 25 study sites in China. Finally, 90 patients with K-Ras gene wild-type were enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nimotuzumab and Gemcitabine | nimotuzumab,400mg/w,Intravenous infusion over 60 minutes,Until disease progression or intolerable toxicity or subjects ask to leave the test. Gemcitabine,1000mg/m2,Intravenous infusion over 30 minutes,Once every three weeks, rest one week (d1,8,15; q28d), Every 4 weeks for a period,Until disease progression or intolerable toxicity or subjects ask to leave the test. nimotuzumab: nimotuzumab,400mg/w,Intravenous infusion over 60 minutes,Until disease progression or intolerable toxicity or subjects ask to leave the test. Gemcitabine: Gemcitabine,1000mg/m2,Intravenous infusion over 30 minutes,Once every three weeks, rest one week (d1,8,15; q28d), Every 4 weeks for a period,Until disease progression or intolerable toxicity or subjects ask to leave the test. |
| 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 | Jun 16, 2014 | Feb 14, 2023 |
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|
| Gemcitabine | Drug | Gemcitabine,1000mg/m2,Intravenous infusion over 30 minutes,Once every three weeks, rest one week (d1,8,15; q28d), Every 4 weeks for a period,Until disease progression or intolerable toxicity or subjects ask to leave the test. |
|
| Placebo | Other | Placebo,400mg/w,Intravenous infusion over 60 minutes,Until disease progression or intolerable toxicity or subjects ask to leave the test. |
|
| Progression Free Survival(PFS) | PFS, defined as from randomization to disease progression or all-cause death. 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. | up to 3 years |
| Objective Response Rate(ORR) | Objective response rate (ORR), including complete response (CR) and partial response (PR). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), at least a 30% decrease in the sum of the longest diameter of target lesions. | Once every eight weeks,up to 5.4 months |
| Disease Control Rate(DCR) | Disease control rate (DCR), including complete response (CR) and partial response (PR) and stable disease(SD). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT/MRI: CR, disappearance of all target lesions; PR, at least a 30% decrease in the sum of the longest diameter of target lesions. SD, neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (PD, defined 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). | Once every eight weeks,up to 5.4 months |
| Clinical Benefit Response(CBR) | The clinical benefit response(CBR)was evaluated every 8 weeks on the basis of the Burris criteria. CBR included pain (intensity of pain and consumption of analgesics), PS (performance status, evaluated according to KPS) and weight changes. Effective is defined as at least one positive improvement in the CBR index (pain, physical status or weight change) and no negative indicator is found, which can be rated as a clinical benefit case. | every 8 weeks, up to 5.4 months |
| Number of Participants With Adverse Events | Adverse Events as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. | up to 75.2 months |
| Hefei |
| Anhui |
| 230601 |
| China |
| Beijing Union Medical College Hospital | Beijing | Beijing Municipality | 100005 | China |
| Chinese Academy of Medical Sciences Cancer Hospital | Beijing | Beijing Municipality | 100021 | China |
| PLA General Hospital (301 Hospital) | Beijing | Beijing Municipality | 100039 | China |
| Affiliated Hospital of Military Medical Sciences | Beijing | Beijing Municipality | 100071 | China |
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China |
| Fuzhou General Hospital of Nanjing Military Region | Fuzhou | Fujian | 350000 | China |
| Fujian Provincial Tumor Hospital | Fuzhou | Fujian | 350014 | China |
| Cancer Hospital of Harbin Medical University | Harbin | Heilongjiang | 150040 | China |
| Jiangyin City People's Hospital | Jiangyin | Jiangsu | 214400 | China |
| Jiangsu Province Tumor Hospital | Nanjing | Jiangsu | 210009 | China |
| Second Affiliated Hospital of Dalian Medical University | Dalian | Liaoning | 116027 | China |
| Shanghai Jiaotong University Affiliated Ruijin Hospital | Shanghai | Shanghai Municipality | 200025 | China |
| Shanghai Fudan University Cancer Hospital | Shanghai | Shanghai Municipality | 200032 | China |
| Shanghai Zhongshan Hospital, Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
| Shanghai Huashan Hospital, Fudan University | Shanghai | Shanghai Municipality | 200040 | China |
| First People's Hospital Cancer Center, Shanghai Jiaotong University | Shanghai | Shanghai Municipality | 200080 | China |
| Shanghai Changhai Hospital | Shanghai | Shanghai Municipality | 200433 | China |
| Affiliated Xijing Hospital, Fourth Military Medical University | Xi’an | Shanxi | 710032 | China |
| General Hospital of Chengdu Military Region | Chengdu | Sichuan | 610083 | China |
| First Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310003 | China |
| Second Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310009 | China |
| Sir Run Run Shaw Hospital | Hangzhou | Zhejiang | 310016 | China |
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310022 | China |
| FG001 | Placebo and Gemcitabine | placebo,400mg/w,Intravenous infusion over 60 minutes,Until disease progression or intolerable toxicity or subjects ask to leave the test. Gemcitabine,1000mg/m2,Intravenous infusion over 30 minutes,Once every three weeks, rest one week (d1,8,15; q28d), Every 4 weeks for a period,Until disease progression or intolerable toxicity or subjects ask to leave the test. Gemcitabine: Gemcitabine,1000mg/m2,Intravenous infusion over 30 minutes,Once every three weeks, rest one week (d1,8,15; q28d), Every 4 weeks for a period,Until disease progression or intolerable toxicity or subjects ask to leave the test. Placebo: Placebo,400mg/w,Intravenous infusion over 60 minutes,Until disease progression or intolerable toxicity or subjects ask to leave the test. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
We screened 90 pts from 480 pts, of whom 8 pts were excluded due to serious violation of the inclusion criteria: 7 pts with K-Ras mutants, 1 pt with gallbladder cancer. Finally, 82 pts were included in FAS.
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| ID | Title | Description |
|---|---|---|
| BG000 | Nimotuzumab- Gemcitabine Group | receive nimotuzumab (400 mg, weekly) plus gemcitabine (1000 mg/m2 on days 1, 8, and 15, every four weeks) until disease progression or unacceptable toxicity. |
| BG001 | Placebo-Gemcitabine Group | receive Placebo plus gemcitabine (1000 mg/m2 on days 1, 8, and 15, every four weeks) until disease progression or unacceptable toxicity. |
| 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Karnofsky performance-status score | The KPS score ranges from 0 to 100, with a higher score indicating better performance status. The scoring is subjectively assigned by a health professional based on the following hierarchical scale: 100=normal, no evidence of disease; 90=able to perform normal activity with only minor symptoms; 80=normal activity with effort, some symptoms; 70=able to care for self but unable to do normal activities; 60=requires occasional assistance, care for most needs. | Count of Participants | Participants |
| |||||||||||||||||
| Diagnosis | Count of Participants | Participants |
| ||||||||||||||||||
| Pancreatic tumor location | Count of Participants | 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 | Overall Survival(OS) | The primary endpoint was overall survival (OS, defined as from randomization to death due to any cause). We screened 90 pts (90 patients were allocated for treatment) from 480 pts, of whom 8 pts were excluded due to serious violation of the inclusion criteria: 7 pts with K-Ras mutants, 1 pt with gallbladder cancer. Finally, 82 pts were included in FAS. The primary end point was evaluated in the full analysis set (FAS; all eligible patients who received at least one dose of nimotuzumab/placebo and had one evaluation of efficacy). | Posted | Median | 95% Confidence Interval | months | up to 3 years |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Time to Progression(TTP) | TTP, defined as from randomization to the first observation of disease progression. 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. | We screened 90 pts (90 patients were allocated for treatment) from 480 pts, of whom 8 pts were excluded due to serious violation of the inclusion criteria: 7 pts with K-Ras mutants, 1 pt with gallbladder cancer. Finally, 82 pts were included in FAS. Secondary end points were analyzed only in the FAS. | Posted | Median | 95% Confidence Interval | months | up to 3 years |
|
| |||||||||||||||||||||||||||||
| Secondary | Progression Free Survival(PFS) | PFS, defined as from randomization to disease progression or all-cause death. 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. | We screened 90 pts (90 patients were allocated for treatment) from 480 pts, of whom 8 pts were excluded due to serious violation of the inclusion criteria: 7 pts with K-Ras mutants, 1 pt with gallbladder cancer. Finally, 82 pts were included in FAS. Secondary end points were analyzed only in the FAS. | Posted | Median | 95% Confidence Interval | months | up to 3 years |
|
| |||||||||||||||||||||||||||||
| Secondary | Objective Response Rate(ORR) | Objective response rate (ORR), including complete response (CR) and partial response (PR). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), at least a 30% decrease in the sum of the longest diameter of target lesions. | We screened 90 pts (90 patients were allocated for treatment) from 480 pts, of whom 8 pts were excluded due to serious violation of the inclusion criteria: 7 pts with K-Ras mutants, 1 pt with gallbladder cancer. Finally, 82 pts were included in FAS. Secondary end points were analyzed only in the FAS. | Posted | Count of Participants | Participants | Once every eight weeks,up to 5.4 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Disease Control Rate(DCR) | Disease control rate (DCR), including complete response (CR) and partial response (PR) and stable disease(SD). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT/MRI: CR, disappearance of all target lesions; PR, at least a 30% decrease in the sum of the longest diameter of target lesions. SD, neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (PD, defined 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). | We screened 90 pts (90 patients were allocated for treatment) from 480 pts, of whom 8 pts were excluded due to serious violation of the inclusion criteria: 7 pts with K-Ras mutants, 1 pt with gallbladder cancer. Finally, 82 pts were included in FAS. Secondary end points were analyzed only in the FAS. | Posted | Count of Participants | Participants | Once every eight weeks,up to 5.4 months |
| |||||||||||||||||||||||||||||||
| Secondary | Clinical Benefit Response(CBR) | The clinical benefit response(CBR)was evaluated every 8 weeks on the basis of the Burris criteria. CBR included pain (intensity of pain and consumption of analgesics), PS (performance status, evaluated according to KPS) and weight changes. Effective is defined as at least one positive improvement in the CBR index (pain, physical status or weight change) and no negative indicator is found, which can be rated as a clinical benefit case. | Posted | Count of Participants | Participants | every 8 weeks, up to 5.4 months |
|
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events | Adverse Events as any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. | We screened 90 pts from 480 pts, of whom 8 pts were excluded due to serious violation of the inclusion criteria: 7 pts with K-Ras mutants, 1 pt with gallbladder cancer. Finally, 90 pts were included in SS (safety set). Adverse Events were analyzed in the SS (n=90). | Posted | Number | participants | up to 75.2 months |
|
|
up to 75.2 months
We screened 90 pts from 480 pts, of whom 8 pts were excluded due to serious violation of the inclusion criteria: 7 pts with K-Ras mutants, 1 pt with gallbladder cancer. Finally, 90 pts were included in SS (safety set). Adverse Events were analyzed in the SS.
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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 | Nimotuzumab- Gemcitabine Group | receive nimotuzumab (400 mg, weekly) plus gemcitabine until disease progression or unacceptable toxicity | 36 | 45 | 15 | 45 | 44 | 45 |
| EG001 | Placebo-Gemcitabine Group | receive placebo plus gemcitabine until disease progression or unacceptable toxicity | 40 | 45 | 5 | 45 | 44 | 45 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fever | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ileus | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| enteritis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| stomachache | Gastrointestinal disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| vomiting | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| bilirubin increased | Investigations | MedDRA 24.0 | Non-systematic Assessment |
| |
| weight decreased | Investigations | MedDRA 24.0 | Non-systematic Assessment |
| |
| Hemoglobin decreased | Investigations | MedDRA 24.0 | Non-systematic Assessment |
| |
| platelet count decreased | Investigations | MedDRA 24.0 | Non-systematic Assessment |
| |
| Embolic cerebral infarction | Vascular disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| diabetic neuropathy | Nervous system disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| coagulopathy | Blood and lymphatic system disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| anemia | Blood and lymphatic system disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| hypoproteinemia | Metabolism and nutrition disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| cholecystitis | Hepatobiliary disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| white blood cell count decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| utrophil count decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Biotech Pharmaceutical Co., Ltd. | 010-51571020 | 8753 | lucy_he@biotechplc.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 10, 2021 | Feb 14, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C501466 | nimotuzumab |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| >=65 years |
|
| Male |
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| Others |
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| 60-80 score |
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| Metastatic |
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| Body |
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| Tail |
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| Units | Counts |
|---|---|
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