NCT04997837View on ClinicalTrials.gov

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

PHASE3RecruitingINTERVENTIONAL
Enrollment

433

Participants

Timeline

Start Date

July 21, 2021

Primary Completion Date

July 21, 2027

Study Completion Date

October 21, 2027

Conditions
Gastric Cancer
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

Trial Locations (1)

200032

RECRUITING

Fudan University Shanghai Cancer Center, Shanghai

All Listed Sponsors
lead

Fudan University

OTHER