Sintilimab Combined With Chemotherapy as Adjuvant Treatment for Phase III GC and GEJ (NCT06761846) | Clinical Trial Compass
RecruitingPhase 2
Sintilimab Combined With Chemotherapy as Adjuvant Treatment for Phase III GC and GEJ
China70 participantsStarted 2025-01-17
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. Patients who had received neoadjuvent treatments before surgery.
✕. Patients who have discovered tumor relapse or metastasis before adjuvent treatment.
What they're measuring
1
3-year disease free survival(DFS) rate
Timeframe: From the time of first dose of adjuvant treatment to the 3 years of the same day
Trial details
NCT IDNCT06761846
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences