Description:
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.
Title
- Brief Title: Study to Evaluate the Efficacy and Safety of Camrelizumab and Apatinib in Patients With GC/GEJC
- Official Title: A Study of Camrelizumab (SHR-1210) Combined With Apatinib Versus Paclitaxel or Irinotecan in Participants With Advanced Gastric/Gastroesophageal Junction Adenocarcinoma Progressed After First-line Chemotherapy
Clinical Trial IDs
- ORG STUDY ID:
SHR-1210-III-316
- NCT ID:
NCT04342910
Conditions
Interventions
Drug | Synonyms | Arms |
---|
camrelizumab | SHR-1210 | camrelizumab (SHR-1210) combined with apatinib |
Apatinib Mesylate | | camrelizumab (SHR-1210) combined with apatinib |
Paclitaxel | | Paclitaxel or Irinotecan |
Irinotecan | | Paclitaxel or Irinotecan |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
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. | - camrelizumab
- Apatinib Mesylate
|
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. | |
Eligibility Criteria
Inclusion Criteria:
1. Histologically- or cytologically-confirmed diagnosis of gastric or gastroesophageal
junction adenocarcinoma.
2. Confirmed metastatic or locally advanced, unresectable disease.
3. Progression on or after prior first-line therapy containing any
platinum/fluoropyrimidine or platinum/taxane doublet.
4. Willing to provide tumor tissue for PD-L1 biomarker analysis.
5. Human epidermal growth factor receptor 2 (HER-2/neu) status known and participants
with HER2/neu positive tumors show documentation of previous treatment containing
trastuzumab.
6. ECOG performance status of 0 to 1.
7. Life expectancy of more than 12 weeks.
8. Signing the informed consent forms.
9. Adequate bone marrow, liver and renal function.
Exclusion Criteria:
1. Squamous cell or undifferentiated gastric cancer.
2. Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
3. Subjects with an active, known or suspected autoimmune disease. Patients with type I
diabetes who are receiving a stable dose of insulin, hypothyroidism who only needs
hormone replacement therapy, and skin diseases (such as eczema, vitiligo, or
psoriasis) that do not require systemic treatment and do not have acute deterioration
within 1 year before the screening period, are allowed.
4. Clinically significant cardiovascular and cerebrovascular diseases.
5. Subjects with high blood pressure who cannot be controlled well with antihypertensive
drugs.
6. Previous digestive tract bleeding history within 3 months or evident gastrointestinal
bleeding tendency.
7. Arterial / venous thrombosis events, such as cerebrovascular accidents (including
transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein
thrombosis, and pulmonary embolism, occurred within the first 6 months of
randomization.
8. Subjects who have previously received anti-PD-1 / PD-L1 monoclonal antibody,
anti-CTLA-4 monoclonal antibody, and VEGFR small molecule inhibitor therapy.
9. Prior systemic chemotherapy, radiotherapy and surgery within 4 weeks before the study
drug administration, or any unresolved AEs > Common Terminology Criteria for Adverse
Events (CTCAE) Grade 1.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Overall Survival (OS) in PD-L1 Positive Participants. |
Time Frame: | Up to 27 months |
Safety Issue: | |
Description: | OS was defined as the time from randomization to death due to any cause. |
Secondary Outcome Measures
Measure: | Overall Survival (OS) in All Participants. |
Time Frame: | Up to 27 months |
Safety Issue: | |
Description: | OS was defined as the time from randomization to death due to any cause. |
Measure: | Progression-free Survival (PFS) According to RECIST 1.1 base on investigator assessment in All Participants or in PD-L1 Positive Participants. |
Time Frame: | Up to 27 months |
Safety Issue: | |
Description: | 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. |
Measure: | Time to Tumor Progression (TTP) According to RECIST 1.1 based on investigator assessment in All Participants or in PD-L1 Positive Participants. |
Time Frame: | Up to 27 months |
Safety Issue: | |
Description: | 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. |
Measure: | Time to Failure (TTF) in All Participants or in PD-L1 Positive Participants |
Time Frame: | Up to 27 months |
Safety Issue: | |
Description: | TTF was defined as the time from randomization to treatment discontinuation caused by any reason. |
Measure: | Objective Response Rate (ORR) According to RECIST 1.1 based on investigator assessment in All Participants or in PD-L1 Positive Participants. |
Time Frame: | Up to 27 months |
Safety Issue: | |
Description: | 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. |
Measure: | Duration of Response (DOR) According to RECIST 1.1 Based on investigator assessment in All Participants or in PD-L1 Positive Participants. |
Time Frame: | Up to 27 months |
Safety Issue: | |
Description: | 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. |
Measure: | Disease Control Rate (DCR) According to RECIST 1.1 based on investigator assessment in All Participants or in PD-L1 Positive Participants. |
Time Frame: | Up to 27 months |
Safety Issue: | |
Description: | 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. |
Measure: | Time to Response (TTR) According to RECIST 1.1 based on investigator assessment in All Participants or in PD-L1 Positive Participants. |
Time Frame: | Up to 27 months |
Safety Issue: | |
Description: | TTR was defined as the time from randomization to the first documented evidence of CR or PR. |
Measure: | The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v4.03. |
Time Frame: | Up to 27 months |
Safety Issue: | |
Description: | The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v4.03. |
Measure: | Proportion of dose suspension, dose reduction or dose discontinuation caused by treatment-related toxicities. |
Time Frame: | Up to 27 months |
Safety Issue: | |
Description: | Proportion of dose suspension, dose reduction or dose discontinuation caused by treatment-related toxicities. |
Measure: | Proportion of anti-camrelizumab antibody (ADA) and neutralizing antibody (Nab) formed during the study from baseline |
Time Frame: | Up to 27 months |
Safety Issue: | |
Description: | Proportion of anti-camrelizumab antibody (ADA) and neutralizing antibody (Nab) formed during the study from baseline |
Measure: | Serum concentration of camrelizumab |
Time Frame: | Up to 27 months |
Safety Issue: | |
Description: | Serum concentration of camrelizumab |
Measure: | Plasma concentration of apatinib |
Time Frame: | Up to 27 months |
Safety Issue: | |
Description: | plasma concentration of apatinib |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Jiangsu HengRui Medicine Co., Ltd. |
Last Updated
February 23, 2021