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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Enrolling; Phase 2

Conditions: Esophagogastric Junction Adenocarcinoma; Gastric Adenocarcinoma

Treatments: Biological: Sintilimab plus Chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06761846

NCC4947

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

Sintilimab + SOX/XELOX

Experimental group

Description:

The study only has one experimental cohort that the subjects who enter the study will receive Sintilimab combined with SOX/XELOX up to 8 cycles, and then receive Sintilimab combined with Tegafur, Gimeracil and Oteracil Potassium Capsules or Capecitabine up to a year ( totally 16 cycles).

Treatment:

Biological: Sintilimab plus Chemotherapy