NCT04342910 Study to Evaluate the Efficacy and Safety of Camrelizumab and Apatinib in Patients With GC/GEJC
| NCT ID | NCT04342910 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Jiangsu HengRui Medicine Co., Ltd. |
| Condition | Gastric Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 550 participants |
| Start Date | 2020-09-21 |
| Primary Completion | 2026-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 550 participants in total. It began in 2020-09-21 with a primary completion date of 2026-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Jianming Xu, Ph.D
PRINCIPAL INVESTIGATOR
Affiliated Hospital, Academy of Military Medical Sciences
Frequently Asked Questions
Who can join the NCT04342910 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Gastric Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04342910 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 550 participants.
Is NCT04342910 currently recruiting?
Yes, NCT04342910 is actively recruiting participants. Contact the research team at wangquanren@hrglobe.cn for enrollment information.
Where is the NCT04342910 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT04342910 clinical trial?
NCT04342910 is sponsored by Jiangsu HengRui Medicine Co., Ltd.. The principal investigator is Jianming Xu, Ph.D at Affiliated Hospital, Academy of Military Medical Sciences. The trial plans to enroll 550 participants.
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