MedTrace Logo

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

NCT04997837 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 433

Last updated 2021-08-10

No results posted yet for this 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.

Conditions

Interventions

DRUG

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.

DRUG

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.

DRUG

Capecitabine

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

DRUG

Tegafur-gimeracil-oteracil potassium

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

DRUG

5-FU

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

RADIATION

Radiotherapy

1.8 Gy/Fx, 45-50.4 Gy

DRUG

Chemotherapy

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

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Zhen Zhang, MD,PhD · Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-21
Primary Completion
2027-07-21
Completion
2027-10-21

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04997837 on ClinicalTrials.gov