Study to Evaluate the Efficacy and Safety of Camrelizumab and Apatinib in Patients With GC/GEJC
- Conditions
- Gastric Cancer
- Interventions
- Registration Number
- NCT04342910
- Lead Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 550
- Histologically- or cytologically-confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma.
- Confirmed metastatic or locally advanced, unresectable disease.
- Progression on or after prior first-line therapy containing any platinum/fluoropyrimidine or platinum/taxane doublet.
- Willing to provide tumor tissue for PD-L1 biomarker analysis.
- 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.
- ECOG performance status of 0 to 1.
- Life expectancy of more than 12 weeks.
- Signing the informed consent forms.
- Adequate bone marrow, liver and renal function.
- Squamous cell or undifferentiated gastric cancer.
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- 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.
- Clinically significant cardiovascular and cerebrovascular diseases.
- Subjects with high blood pressure who cannot be controlled well with antihypertensive drugs.
- Previous digestive tract bleeding history within 3 months or evident gastrointestinal bleeding tendency.
- 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.
- Subjects who have previously received anti-PD-1 / PD-L1 monoclonal antibody, anti-CTLA-4 monoclonal antibody, and VEGFR small molecule inhibitor therapy.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Paclitaxel or Irinotecan Paclitaxel 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. Paclitaxel or Irinotecan Irinotecan 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. camrelizumab (SHR-1210) combined with apatinib Apatinib Mesylate Participants will receive camrelizumab on Day 1 and Day 15 of each 28-day cycle and apatinib mg/day up to 2 years. camrelizumab (SHR-1210) combined with apatinib camrelizumab Participants will receive camrelizumab on Day 1 and Day 15 of each 28-day cycle and apatinib mg/day up to 2 years.
- Primary Outcome Measures
Name Time Method Overall Survival (OS) in PD-L1 Positive Participants. Up to 27 months OS was defined as the time from randomization to death due to any cause.
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) in All Participants. Up to 27 months OS was defined as the time from randomization to death due to any cause.
Progression-free Survival (PFS) According to RECIST 1.1 base on investigator assessment in All Participants or in PD-L1 Positive Participants. Up to 27 months 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.
Time to Tumor Progression (TTP) According to RECIST 1.1 based on investigator assessment in All Participants or in PD-L1 Positive Participants. Up to 27 months 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.
Time to Failure (TTF) in All Participants or in PD-L1 Positive Participants Up to 27 months TTF was defined as the time from randomization to treatment discontinuation caused by any reason.
Duration of Response (DOR) According to RECIST 1.1 Based on investigator assessment in All Participants or in PD-L1 Positive Participants. Up to 27 months 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.
Disease Control Rate (DCR) According to RECIST 1.1 based on investigator assessment in All Participants or in PD-L1 Positive Participants. Up to 27 months 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.
Objective Response Rate (ORR) According to RECIST 1.1 based on investigator assessment in All Participants or in PD-L1 Positive Participants. Up to 27 months 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.
Time to Response (TTR) According to RECIST 1.1 based on investigator assessment in All Participants or in PD-L1 Positive Participants. Up to 27 months TTR was defined as the time from randomization to the first documented evidence of CR or PR.
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v4.03. Up to 27 months The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v4.03.
Proportion of dose suspension, dose reduction or dose discontinuation caused by treatment-related toxicities. Up to 27 months Proportion of dose suspension, dose reduction or dose discontinuation caused by treatment-related toxicities.
Proportion of anti-camrelizumab antibody (ADA) and neutralizing antibody (Nab) formed during the study from baseline Up to 27 months Proportion of anti-camrelizumab antibody (ADA) and neutralizing antibody (Nab) formed during the study from baseline
Serum concentration of camrelizumab Up to 27 months Serum concentration of camrelizumab
Plasma concentration of apatinib Up to 27 months plasma concentration of apatinib
Trial Locations
- Locations (1)
Affiliated Hospital, Academy of Military Medical Sciences
🇨🇳Beijing, China