Camrelizumab plus apatinib for advanced gastric and gastroesophageal junction adenocarcinoma
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
This trial tests whether combining camrelizumab and apatinib can help people with advanced gastric or gastroesophageal junction cancer that progressed after first-line platinum-based therapy, especially if their tumors are PD-L1 positive.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 550 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Jiangsu HengRui Medicine Co., Ltd. Industry-sponsored |
| Drugs / interventions | trastuzumab, chemotherapy, camrelizumab, apatinib |
| Locations | 1 site (Beijing) |
| Trial ID | NCT04342910 on ClinicalTrials.gov |
What this trial studies
This is a phase 3 interventional trial enrolling patients with metastatic or unresectable gastric or gastroesophageal junction adenocarcinoma whose disease progressed after first-line platinum-containing therapy. Participants must provide tumor tissue for PD-L1 testing and have known HER2 status; those with HER2-positive tumors should have prior trastuzumab. The experimental approach gives camrelizumab (a PD-1 antibody) together with apatinib (a VEGFR2 inhibitor); paclitaxel and irinotecan are listed among other interventions used per protocol. The primary hypothesis is that the camrelizumab plus apatinib combination will prolong overall survival in PD-L1–positive tumors.
Who should consider this trial
Good fit: Ideal candidates are adults with histologically confirmed metastatic or unresectable gastric or gastroesophageal junction adenocarcinoma who progressed after first-line platinum/fluoropyrimidine or platinum/taxane therapy, have ECOG 0–1, adequate organ function, and are willing to provide tumor tissue for PD-L1 testing.
Not a fit: Patients with active autoimmune disease, untreated or active central nervous system metastases, poor performance status (ECOG ≥2), or tumors that are PD-L1 negative may be unlikely to benefit from this regimen.
Why it matters
Potential benefit: If successful, the combination could extend overall survival for patients with PD-L1–positive advanced gastric or gastroesophageal junction adenocarcinoma who progressed after first-line platinum-based therapy.
How similar studies have performed: Earlier-phase studies combining PD-1 pathway inhibitors with anti-angiogenic agents have shown signals of activity in gastric cancer and early reports of camrelizumab plus apatinib indicated promising response rates in prior smaller trials.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing
- Affiliated Hospital, Academy of Military Medical Sciences — Beijing, China (Recruiting)
Study contacts
- Principal investigator: Jianming Xu, Ph.D — Affiliated Hospital, Academy of Military Medical Sciences
- Study coordinator: Quanren Wang, Ph.D
- Email: wangquanren@hrglobe.cn
- Phone: +862161053363
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.