Combining Sintilimab with Chemotherapy for Stage III Gastric Cancer Treatment
A Phase II Study of Sintilimab Combined With Chemotherapy as Postoperative Adjuvant Treatment for Phase III Gastric Adenocarcinoma (GC) and The Adenocarcinoma of Esophagogastric Junction (GEJ)
This study is testing if combining a new drug called Sintilimab with chemotherapy can help people with stage III gastric cancer feel better after their surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, Sintilimab |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06761846 on ClinicalTrials.gov |
What this trial studies
This phase II clinical study aims to evaluate the efficacy and safety of Sintilimab combined with chemotherapy in patients with stage III gastric adenocarcinoma and esophagogastric junction adenocarcinoma following radical resection. Participants will receive either the SOX or XELOX chemotherapy regimen for a total of 16 cycles, with efficacy assessed every four cycles. The study includes comprehensive follow-up to monitor adverse events, disease status, and quality of life for up to five years post-treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histopathologically confirmed stage III gastric or GEJ adenocarcinoma who have undergone D2 surgery.
Not a fit: Patients with prior neoadjuvant treatments, tumor relapse, or other malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve survival rates and quality of life for patients with advanced gastric cancer.
How similar studies have performed: Similar studies combining immunotherapy with chemotherapy have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥18. 2. Patients with histopathological confirmed gastric/GEJ adenocarcinoma. 3. The pTNM is confirmed between IIIA-IIIC and the PD-L1 CPS\>=1. 4. Patients treated with D2 surgery. 5. ECOG is 0 or 1. 6. Patients who could tolerate chemotherapy combined with immunotherapy. 7. Patients who are not pregnant and have no willing to get pregnant within 6 months after the treatment is over. 8. Patients who are willing to offer their postoperative tumor tissue and their peripheral blood samples. 9. Patients who are volunteer to sign the ICF. Exclusion Criteria: 1. Patients who had received neoadjuvent treatments before surgery. 2. Patients who have discovered tumor relapse or metastasis before adjuvent treatment. 3. Patients who have other malignant tumors. 4. Patients who could not swallow the tablets and capsules. 5. Other conditions which the researchers think are not suitable for participate the study.
Where this trial is running
Beijing, Beijing Municipality
- Cancer Hodpital, Chinese Academy of Medical Sciences and Peking Union Medical College — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: LIN YANG, Doctor — Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Study coordinator: LIN YANG, Doctor
- Email: linyangcicams@126.com
- Phone: 010-13681015148
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.