NCT06761846RecruitingPhase 2
Sintilimab Combined With Chemotherapy as Adjuvant Treatment for Phase III GC and GEJ
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)
Source: ClinicalTrials.gov · Last updated 21 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 28 Dec 2024
- Start date
- 17 Jan 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06761846
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 70
- From 17 Jan 2025 to the primary completion date, 31 Dec 2027
- 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
- Patients who had received neoadjuvent treatments before surgery.
Other illness
- Patients who have other malignant tumors.
- Other conditions which the researchers think are not suitable for participate the study.
Other
- Patients who have discovered tumor relapse or metastasis before adjuvent treatment.
- Patients who could not swallow the tablets and capsules.
Who the study is looking for
- Age ≥18.
- Patients with histopathological confirmed gastric/GEJ adenocarcinoma.
- The pTNM is confirmed between IIIA-IIIC and the PD-L1 CPS\>=1.
- Patients treated with D2 surgery.
- ECOG is 0 or 1.
- Patients who could tolerate chemotherapy combined with immunotherapy.
- Patients who are not pregnant and have no willing to get pregnant within 6 months after the treatment is over.
- Patients who are willing to offer their postoperative tumor tissue and their peripheral blood samples.
- Patients who are volunteer to sign the ICF.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cancer Hodpital, Chinese Academy of Medical Sciences and Peking Union Medical College Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.