Sintilimab Combined With Chemotherapy as Adjuvant Treatment for Phase III GC and GEJ
Recruiting now · Phase 2
Conditions studied: Gastric Adenocarcinoma, Esophagogastric Junction Adenocarcinoma
In brief
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.
Key facts
- Study ID
- NCT06761846
- Run by
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- People needed
- 70
- Starts
- 2025-01-17
- Expected to finish
- 2028-12-31
- Last updated by the study team
- 2026-04-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Patients who had received neoadjuvent treatments before surgery.
- Patients who have discovered tumor relapse or metastasis before adjuvent treatment.
- Patients who have other malignant tumors.
- Patients who could not swallow the tablets and capsules.
- Other conditions which the researchers think are not suitable for participate the study.
Where it is running
- Cancer Hodpital, Chinese Academy of Medical Sciences and Peking Union Medical College — Beijing, Beijing Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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