RecruitingPhase 3NCT04997837

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

A Multicenter, Randomized, Controlled Phase III Study of Chemotherapy With or Without PD-1 Inhibitors and Chemoradiotherapy as Adjuvant Regimen for D2/R0 Resected pN3 Gastric (G) or Gastroesophageal Junction (GEJ) Adenocarcinoma


Sponsor

Fudan University

Enrollment

433 participants

Start Date

Jul 21, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding an immunotherapy drug (PD-1 inhibitor) to standard chemotherapy and chemoradiotherapy after surgery improves outcomes for patients with stomach (gastric) or gastroesophageal junction cancer that had extensive lymph node involvement (more than 7 positive nodes) at the time of surgery. **You may be eligible if...** - You are in good general health (ECOG 0–1) with expected survival more than 6 months - You had a complete D2/R0 surgical removal of your stomach or GEJ cancer - Your cancer had more than 7 positive lymph nodes (stage pN3) with no distant spread - Your blood counts, liver, and kidney function meet required standards - You are willing to provide blood and tissue samples **You may NOT be eligible if...** - You had peritoneal spread of cancer (with some exceptions) - You received any anti-cancer treatment before surgery - You have an active autoimmune disease requiring systemic treatment - You have known HIV, active tuberculosis, active hepatitis B or C - You are pregnant or breastfeeding - You have had another cancer in the past 5 years (except treated basal cell skin cancer or carcinoma in situ) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPD-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.

DRUGOxaliplatin

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.

DRUGCapecitabine

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

DRUGTegafur-gimeracil-oteracil potassium

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

DRUG5-FU

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

RADIATIONRadiotherapy

1.8 Gy/Fx, 45-50.4 Gy

DRUGChemotherapy

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


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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NCT04997837


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