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Sintilimab Combined With Chemotherapy as Adjuvant Treatment for Phase III GC and GEJ

RecruitingPhase 2Ages 18 Years - anyAllCancer Institute and Hospital, Chinese Academy of…
NCT06761846 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Sintilimab plus Chemotherapy
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Where

1 site
Cancer Hodpital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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