🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT04997837
Recruiting Phase 3

Study of Adjuvant Chemotherapy With or Without PD-1 Inhibitors and Chemoradiotherapy in Resected pN3 Gastric (G) or GEJ Adenocarcinoma

NCT04997837 · tracked via the Priya Life Science China tracker
Sponsor
Fudan University
Phase
Phase 3
Started
2021-07-21
Last updated
2021-08-10

Condition(s) studied

Gastric Cancer

Investigational drug(s) / intervention(s)

PD-1 inhibitor →Oxaliplatin →Capecitabine →Tegafur-gimeracil-oteracil potassium →5-FU →RadiotherapyChemotherapy

PD-1 inhibitor: Nivolumab/Toripalimab 240mg solution intravenously once daily, Q2W. OR Nivolumab/Toripalimab 360mg solution intravenously once daily, Q3W; OR Pembrolizumab/Tilelizumab/Sintilimab/Carrelizumab, 200mg solution intravenously once daily, Q3W.

Oxaliplatin: CapeOx: 130 mg/m2 (body surface area) solution intravenously once-daily, followed by 20 days off. FOLFOX: 85 mg/m2 (body surface area) solution intravenously once-daily, followed by 13 days off.

Capecitabine: CapeOx: 1000 mg2 (body surface area) bid orally in 14 days, followed by 7 days off.

Tegafur-gimeracil-oteracil potassium: SOX: 40 - 60 mg bid orally in 14 days, followed by 7 days off

5-FU: FOLFOX:2400-2800mg/m2/d continuous intravenous pumping for 48h, Q2W

Radiotherapy: 1.8 Gy/Fx, 45-50.4 Gy

Chemotherapy: Capecitabine 625mg/m2 bid orally with radiotherapy; ORegafur-gimeracil-oteracil potassium combination drug 40-60mg bid orally with radiotherapy

Study summary

The purpose of the study is to evaluate the efficacy and safety of postoperative adjuvant chemotherapy with PD-1 inhibitors and chemoradiotherapy, in comparison with adjuvant chemotherapy only, in D2/R0 resected pN3 gastric or gastroesophageal junction adenocarcinoma. PD-1+CRT cohort: A total of 216 patients will receive 6 weeks of PD-1 inhibitors and chemotherapy, then receive concurrent chemoradiotherapy, followed by 6 weeks of PD-1 inhibitors and chemotherapy, finally receive maintenance treatment of PD-1 inhibitors until (maximum 1year after radiotherapy). CT cohort: A total of 217 patients will receive 6 months of chemotherapy. The disease-free survival(DFS), overall survival(OS) and adverse effects will be analyzed.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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 cell detection 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≥1.5\*10\^9/L, PLT≥100\*10\^9/L, ALT \& AST≤2.5 U/L, TB ≤ 1.5 UNL, serum creatinine\<1 UNL. * Patients who are willing to obey regimens during the study. * Written informed consent is acquired before random entry, and patients should know that 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 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 treatment within 2 years before first medication in the study, substitutive therapy (such as thyroxine, insulin, etc) excluded. * Patients diagnosed with immunodeficiency, or was receiving systematic glucocorticoid treatment or other immunosuppressive therapy within 7 days before medication, physiological dose of glucocorticoid is allowed (≤10 mg/d prednison or equivalent medication) * Patients who have known severe allergic reaction (≥level 3) to anti-PD-1 monoclonal antibody, 5-FU, Oxaliplatin or any auxiliary material. * Patient diagnosed with other malignant tumor in the past 5 years, excluding radical basal 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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Fudan University Shanghai Cancer Center Shanghai Shanghai Municipality Recruiting

More Fudan University trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04997837 on ClinicalTrials.gov ↗ ← All trials in China