NCT06761846 Sintilimab Combined With Chemotherapy as Adjuvant Treatment for Phase III GC and GEJ
| NCT ID | NCT06761846 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
| Condition | Gastric Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2025-01-17 |
| Primary Completion | 2027-12-31 |
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.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 70 participants in total. It began in 2025-01-17 with a primary completion date of 2027-12-31.
⚠ 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 study is a prospective, single-arm, phase II clinical study. Screening patients with stage III GC/GEJ adenocarcinoma after D2 or broader radical resection. After enrolling in the study, the subjects receive Sintilimab combined with oxaliplatin+Tegafur, Gimeracil and Oteracil Potassium Capsules (SOX) or oxaliplatin+Capecitabine (XELOX) , in which the combined chemotherapy is up to 8 cycles, and the total course of treatment was 16 cycles. The following-up of subjects includes adverse events、disease status、living conditions and the quality of life.
Eligibility 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.
Contact & Investigator
LIN YANG, Doctor
PRINCIPAL INVESTIGATOR
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Frequently Asked Questions
Who can join the NCT06761846 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Gastric Adenocarcinoma. 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 NCT06761846 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06761846 currently recruiting?
Yes, NCT06761846 is actively recruiting participants. Contact the research team at linyangcicams@126.com for enrollment information.
Where is the NCT06761846 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06761846 clinical trial?
NCT06761846 is sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. The principal investigator is LIN YANG, Doctor at Cancer Institute and Hospital, Chinese Academy of Medical Sciences. The trial plans to enroll 70 participants.