NCT04342910RecruitingPhase 3
Study to Evaluate the Efficacy and Safety of Camrelizumab and Apatinib in Patients With GC/GEJC
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
Source: ClinicalTrials.gov · Last updated 20 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 550 (estimated)
- First submitted
- 9 Apr 2020
- Start date
- 21 Sept 2020
- Primary completion date
- 1 Apr 2026
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT04342910
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 550
- From 21 Sept 2020 to the primary completion date, 1 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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.
- 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.
Other illness
- Squamous cell or undifferentiated gastric cancer.
- Clinically significant cardiovascular and cerebrovascular diseases.
- 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.
Other
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Affiliated Hospital, Academy of Military Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.