Last updated: August 1, 2021
Sponsor: Fudan University
Overall Status: Active - Recruiting
Phase
3
Condition
Gastric Cancer
Adenocarcinoma
Treatment
N/AClinical Study ID
NCT04997837
FDRT-2021-63-2366
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1
- Patients with expected survival time more than 6 months
- Patients after standard D2/R0 resection
- Postoperative histologically confirmed adenocarcinoma of the stomach or GEJ
- Positive lymph nodes more than 7, stage pN3
- Patients without distant metastasis (M0) or M1 with abdominal exfoliated celldetection positive (CY1P0)
- Patients' physical condition and visceral function allows following adjuvant therapy,including chemotherapy, chemoradiotherapy and PD-1 inhibitor therapy.
- Patients' blood routine and biochemical indicators should meet the following standard:Hb≥90g/L, ANC≥1.510^9/L, PLT≥10010^9/L, ALT & AST≤2.5 U/L, TB ≤ 1.5 UNL, serumcreatinine<1 UNL.
- Patients who are willing to obey regimens during the study.
- Written informed consent is acquired before random entry, and patients should knowthat he/she has the right to quit, and following treatment won't be affected.
- Patients are willing to provide samples of blood and tissue.
Exclusion
Exclusion Criteria:
- Patients with gross peritoneal metastasis (CY1P0 excluded) or distant metastasis.
- Patients who has received any anti-tumor therapy before surgery.
- Patients who had received radiotherapy for abdominal organs including stomach, liver,kidney, etc.
- Patients who had active systematic autoimmune diseases which need systematic treatmentwithin 2 years before first medication in the study, substitutive therapy (such asthyroxine, insulin, etc) excluded.
- Patients diagnosed with immunodeficiency, or was receiving systematic glucocorticoidtreatment or other immunosuppressive therapy within 7 days before medication,physiological dose of glucocorticoid is allowed (≤10 mg/d prednison or equivalentmedication)
- Patients who have known severe allergic reaction (≥level 3) to anti-PD-1 monoclonalantibody, 5-FU, Oxaliplatin or any auxiliary material.
- Patient diagnosed with other malignant tumor in the past 5 years, excluding radicalbasal cell carcinoma of the skin and/or radical resected carcinoma in situ.
- Patient with severe vital organ failure.
- Pregnant or lactation period
- Patient with known mental illness or drug abuse that may influence compliance.
- Patient with known HIV infection, or active tuberculosis.
- Untreated active hepatitis B
- Patient with active HCV infection
- Uncontrolled complications
- Other situations that might disturb study results and compliance.
Study Design
Total Participants: 433
Study Start date:
July 21, 2021
Estimated Completion Date:
October 21, 2027
Connect with a study center
Fudan University Shanghai Cancer Center
Shanghai, Shanghai 200032
ChinaActive - Recruiting

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