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The purpose of this study was to evaluate the overall survival time (OS), objective remission rate(ORR), progression-free survival time(PFS), disease control rate(DCR)of Carelizumab combined with irinotecan and apatinib for the second-line treatment of locally advanced unresectable, recurrent or metastatic adenocarcinoma of stomach and gastroesophageal junction. At the same time, the safety and tolerance of the scheme were preliminarily evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carelizumab Combined With Irinotecan and Apatinib | Experimental | Second-line treatment of advanced gastric cancer with three-drug regimen(Carelizumab Combined With Irinotecan and Apatinib ) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carelizumab Combined With Irinotecan and Apatinib | Drug | Three-drug regimen was used in second-line treatment of Advanced gastric cancer |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Suvival time(OS) | The time from randomization to death due to any reason. For those who have lost follow-up before death, the last follow-up time is usually calculated as the time of death. | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progress Free Survival time(PFS) | The time from randomization to the first occurrence of disease progression or death from any cause. | Up to 24 months |
| objective response rate(ORR) | Refers to the proportion of patients whose tumors have shrunk to a certain amount and kept for a certain time, including CR and PR cases |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability | The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v4.03 | Up to 24 months |
Inclusion Criteria:
Exclusion Criteria:
13. after regular antihypertensive treatment, the blood pressure still cannot fall to the normal range (systolic blood pressure > >140mmHg, diastolic blood pressure > >90mmHg).
14. ≥II grade ii coronary heart disease and arrhythmia (including QTc interval prolongation > >450ms for men and > >470ms for women).
15. Symptomatic congestive heart failure (new york Heart Association Grade II-IV) or symptomatic or poorly controlled arrhythmia.
16. before the first administration, there was toxicity caused by previous anti-tumor treatment that did not recover to grade 0 or grade 1 of the national cancer institute general adverse event terminology version 4.03 (NCI ctcae version 4.03) (excluding alopecia, fatigue and asymptomatic laboratory abnormalities).
17. abnormal coagulation function (INR > 1.5 uln, aptt > 1.5 uln), with bleeding tendency.
18. It is known that symptomatic central nervous system metastasis exists. 19. Diagnosed as other malignant tumors within 5 years before the first administration, excluding basal cell carcinoma of skin, squamous cell carcinoma of skin and carcinoma in situ after radical resection.
20. Active infections requiring treatment or systemic anti-infective drugs used within 7 days before the first administration.
21. acute or chronic active hepatitis b: HBV viral load ≥500 copies /ml 22. Any arterial thrombosis, embolism or ischemia, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, occurred within 6 months before the study.
23. It is known that there are mental diseases or drug abuse situations that may affect the compliance with the test requirements.
24. Acute or chronic active hepatitis C: HCV antibody is positive. 25. Pregnant or lactating women. 26. There are medical histories, diseases, treatments or abnormal laboratory results that may interfere with the test results and prevent the subjects from participating in the study, or the researchers think that participating in the study is not in the best interests of the subjects.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Min Shi | Contact | 020-62787736 | nfyyshimin@163.com | |
| Chunlin Wang | Contact | 020-62787735 | wangchunl03@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Min Shi | Oncology department of Nanfang hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NanFang Hospital | Recruiting | Guangzhou | Guangdong | 510515 | China |
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| Up to 24 months |
| duration of response (DoR) | It is the curative effect evaluation index of tumor reaction, which refers to the time from the first evaluation of complete remission (CR) or partial remission (PR) to the first evaluation of disease progression (PD) or death from any cause | Up to 24 months |
| Disease control rate(DCR) | The proportion of patients whose tumors have shrunk or remained stable for a certain period of time, including cases of complete remission (CR), partial remission (PR) and stable (SD) | Up to 24 months |
| 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 |
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| ID | Term |
|---|---|
| D000077146 | Irinotecan |
| C553458 | apatinib |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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