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)
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
70 participants
Jan 17, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria9
- 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.
Exclusion Criteria5
- 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.
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Interventions
chemotherapy includes SOX and XELOX
Locations(1)
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NCT06761846