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This is a study for participants with advanced gastric or gastroesophageal junction adenocarcinoma who have had tumor progression after first-line platinum-contained therapy. The primary study hypotheses are that camrelizumab (SHR-1210) combined with apatinib prolongs overall survival (OS) for participants with tumors that show positive programmed cell death ligand 1 (PD-L1) expression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| camrelizumab (SHR-1210) combined with apatinib | Experimental | Participants will receive camrelizumab on Day 1 and Day 15 of each 28-day cycle and apatinib mg/day up to 2 years. |
|
| Paclitaxel or Irinotecan | Active Comparator | Participants receive paclitaxel on Days 1, 8, and 15 of each 28-day cycle, or irinotecan on Days 1 and 15 of each 28-day cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| camrelizumab | Drug | 200 mg intravenous (IV) camrelizumab on Day 1 and Day 15 of each 28-day cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) in PD-L1 Positive Participants. | OS was defined as the time from randomization to death due to any cause. | Up to 27 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) in All Participants. | OS was defined as the time from randomization to death due to any cause. | Up to 27 months |
| Progression-free Survival (PFS) According to RECIST 1.1 base on investigator assessment in All Participants or in PD-L1 Positive Participants. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Quanren Wang, Ph.D | Contact | +862161053363 | wangquanren@hrglobe.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jianming Xu, Ph.D | Affiliated Hospital, Academy of Military Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hospital, Academy of Military Medical Sciences | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| C553458 | apatinib |
| D017239 | Paclitaxel |
| D000077146 | Irinotecan |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Apatinib Mesylate | Drug | 250 mg qd |
|
| Paclitaxel | Drug | 80 mg/m^2 administered as IV infusion on Days 1, 8, and 15 of each 28-day cycle. |
|
| Irinotecan | Drug | 180 mg/m^2 administered as IV infusion on Days 1, and 15 of each 28-day cycle. |
|
PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on investigator assessment, or death due to any cause, whichever occurs first. |
| Up to 27 months |
| Time to Tumor Progression (TTP) According to RECIST 1.1 based on investigator assessment in All Participants or in PD-L1 Positive Participants. | TTP was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on investigator assessment in All Participants. | Up to 27 months |
| Time to Failure (TTF) in All Participants or in PD-L1 Positive Participants | TTF was defined as the time from randomization to treatment discontinuation caused by any reason. | Up to 27 months |
| Objective Response Rate (ORR) According to RECIST 1.1 based on investigator assessment in All Participants or in PD-L1 Positive Participants. | ORR was defined as the percentage of the participants in the analysis population who had a confirmed CR or PR according to RECIST 1.1 based on investigator assessment. | Up to 27 months |
| Duration of Response (DOR) According to RECIST 1.1 Based on investigator assessment in All Participants or in PD-L1 Positive Participants. | DOR was defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first. | Up to 27 months |
| Disease Control Rate (DCR) According to RECIST 1.1 based on investigator assessment in All Participants or in PD-L1 Positive Participants. | DCR was defined as the percentage of the participants in the analysis population who had a confirmed CR or PR or SD according to RECIST 1.1 based on investigator assessment. | Up to 27 months |
| Time to Response (TTR) According to RECIST 1.1 based on investigator assessment in All Participants or in PD-L1 Positive Participants. | TTR was defined as the time from randomization to the first documented evidence of CR or PR. | Up to 27 months |
| The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v4.03. | The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v4.03. | Up to 27 months |
| Proportion of dose suspension, dose reduction or dose discontinuation caused by treatment-related toxicities. | Proportion of dose suspension, dose reduction or dose discontinuation caused by treatment-related toxicities. | Up to 27 months |
| Proportion of anti-camrelizumab antibody (ADA) and neutralizing antibody (Nab) formed during the study from baseline | Proportion of anti-camrelizumab antibody (ADA) and neutralizing antibody (Nab) formed during the study from baseline | Up to 27 months |
| Serum concentration of camrelizumab | Serum concentration of camrelizumab | Up to 27 months |
| Plasma concentration of apatinib | plasma concentration of apatinib | Up to 27 months |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |