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This is a study of Camrelizumab combined with Apatinib versus Apatinib alone in the third-line treatment of metastatic gastric cancer. Paticipants will be radomized to receive treatment of Camrelizumab combined with Apatinib or Apatinib alone. The primary study hypothesis is that the adding Camrelizumab to Apatinib can prolong the progressive-free survival of the paticipants.
Camrelizumab 200mg intravenously 30 - 60 min biweekly; Apatinib mesylate 250mg or 500mg oral daily continuously; The treatment lasts for up to 2 years or until disease progression, death or intolerable toxicity occurred.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | A fixed dose of Camrelizumab 200mg will be administered intravenously (without preventive medication), and each infusion lasts 45min (no less than 30min, no more than 60min), once every two weeks; During the treatment period, 250 mg of Apatinib mesylate tablets will be taken orally daily continuously, and every 2 weeks is a treatment cycle. The treatment lasts for up to 2 years or until disease progression, death or intolerable toxicity occurred. |
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| Control group | Active Comparator | Apatinib mesylate tablets 500 mg will be taken orally daily continuously, every 2 weeks as a treatment cycle. Treatment lasts for up to 2 years or until disease progression, death or intolerable toxicity occurs. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab | Drug | a PD-1 antibody |
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| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | the interval from randomization to tumor progression or death or the last follow-up | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | the interval from randomization to death of any reason or the last follow-up | 2 years |
| Objective response rate | the proportion of subjects who achieve a best response of complete response (CR) or partial response (PR) using the RECIST 1.1 criteria |
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Inclusion Criteria:
1) Hemoglobin ≥ 9.0 g/dL; 2) Absolute neutrophil count (ANC) ≥ 1,500/mm3; 3) Platelet count≥ 100,000/mm3; 4) Total bilirubin ≤ 1.5 times the upper limit of normal value (ULN); 5) Alanine aminotransferase and aspartate aminotransferase ≤ 2.5 ULN; 6) The international standardized ratio of prothrombin time is ≤ 1.5, and part of the thromboplastin time is within the normal range (the lower limit of 1.2 times normal value to the upper limit of 1.2 times normal value); 7) Creatinine ≤ 1.5 ULN; 8) Urine protein <2+ (if urine protein ≥ 2+, then 24h urine protein quantitative protein must be ≤ 1g); 4.The presence of measurable lesions in patients; evaluated by investigators according to the Efficacy Evaluation Criteria (RECIST) v1.1 of Solid Tumors; 5.Eastern Tumor Collaboration Group Behavioral Status Score (ECOG PS) of 0 or 1; 6.Life expectancy ≥ 3 months; 7.The investigator assessed that the patient was able to comply with the protocol requirements; 8.Capable to sign the informed consent document.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jian Xiao, PhD | Contact | 13711114566 | xiaoj26@mail.sysu.edu.cn | |
| Shanshan Li, MD | Contact | 13450423491 | lishsh38@mail.sysu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jian Xiao, PhD | Sixth Affiliated Hospital, Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Sixth Affiliated hosipital, Sun Yat-Sen University | Guangzhou | Guangdong | 510655 | China |
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| Apatinib Mesylate | Drug | an oral tyrosine kinase inhibitor |
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| 2 years |
| Quality of Life assessed by EORTC QLQ-OG 25 | The Europe Organization for Research and Treatment of Cancer,Quality of Life Questionnaire-OG 25 can assess quality of life (HRQL) in patients with tumours of the oesophagus, oesophago-gastric junction and stomach. | 2 years |
| Toxicity assessed by CTCAE V5.0 | Adverse effects recorded according to CTCAE V5.0 | 2 years |
| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| C553458 | apatinib |
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