Camrelizumab and Apatinib for Advanced Gastric Cancer
Study to Evaluate the Efficacy and Safety of Camrelizumab and Apatinib in Patients With GC/GEJC
Recruiting
Phase 3Interventional Study
Gastric Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
550 (estimated)
Sponsor
Jiangsu HengRui Medicine Co., Ltd. · Industry
Who this trial is looking for
This trial is looking for people with advanced gastric cancer who have not responded to initial treatment. Participants will take Camrelizumab and Apatinib to see if it helps them live longer.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with gastric cancer.
I have metastatic or locally advanced, unresectable gastric cancer.
My cancer has progressed after previous treatment.
I am willing to provide tumor tissue for testing.
I know my HER-2/neu status.
I have a good performance status.
I expect to live more than 12 weeks.
I have signed the informed consent forms.
You may not be able to join if
I have squamous cell or undifferentiated gastric cancer.
I have known active brain metastases.
I have an active autoimmune disease.
I have clinically significant heart or brain diseases.
My high blood pressure is not well controlled.
I have had digestive tract bleeding in the last 3 months.
I have had blood clot events in the last 6 months.
I have received certain previous cancer therapies.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 Locations
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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 plat…
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.
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