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

Официальное название

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)

Обзор

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.

Подробное описание

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 that meets the criteria for group entry and does not meet the exclusion criteria. After signing the informed consent, the subjects entered the trial group to receive adjuvant treatment with Sintilimab combined with chemotherapy (SOX or XELOX ), in which SOX or XELOX chemotherapy was up to 8 cycles, and the total course of treatment was 16 cycles. The efficacy is evaluated every 4 cycles during the study treatment. The frequency of follow-up after treatment is defined as: once every 3 months within 2 years after surgery, every 6 months for 2 to 5 years, and once a year after 5 years. The follow-up interval can be adjusted according to the clinical need. Safety follow-up is from the beginning of the first treatment to 30 days after the last medication.

Вмешательства

• Биопрепарат Sintilimab plus Chemotherapy
  chemotherapy includes SOX and XELOX

Первичные конечные точки

• 3-year disease free survival(DFS) rate [Срок оценки: From the time of first dose of adjuvant treatment to the 3 years of the same day]

Вторичные конечные точки (3)

• DFS [Срок оценки: From the time of first dose of adjuvant treatment to the time when the subjects have confirmed disease progress]
• overall survival (OS) [Срок оценки: From the time of first dose of adjuvant treatment to the time when the subjects have died for all causes]
• safety [Срок оценки: collect all adverse events since the last medication up to 30 days]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Cancer Hodpital, Chinese Academy of Medical Sciences and Peking Union Medical College — Пекин

Идентификаторы

NCT: NCT06761846 · NCC4947

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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