The Combination of Hypofractionated Radiotherapy and Immunotherapy in Locally Recurrent Rectal Cancer

PHASE2RecruitingINTERVENTIONAL
Enrollment

93

Participants

Timeline

Start Date

November 30, 2022

Primary Completion Date

December 1, 2024

Study Completion Date

December 1, 2025

Conditions
Recurrent Rectal Cancer
Interventions
DRUG

PD-1 antibody

PD-1 antibody (Toripalimab): 240mg q3w or 160mg q2w

DRUG

Capecitabine

Capecitabine: 1000mg/m2 d1-14 q3w

DRUG

5FU

400 mg/m2 (bolus) and 2400 mg/m2 (continuous infusion for 48hr)

DRUG

folinic acid

400 mg/m2 q2w

DRUG

Oxaliplatin

130 mg/m² q3w or 85 mg/m² q2w

DRUG

Irinotecan

180 mg/m² q2w and 200 mg/m² q3w

DRUG

Raltitrexed

2 mg/m² q2w and 3 mg/m² q3w

DRUG

Cetuximab

400 mg/m² q2w

DRUG

Bevacizumab

5 mg/kg q2w or 7.5mg/kg q3w

RADIATION

Radiation

"25-40Gy/5Fx irradiation or 15-30Gy/5Fx reirradiation (pelvic radiation history) for pelvic recurrence tumor.~35-60Gy/5-8Fx irradiation for distance metastasis tumor."

Trial Locations (1)

200032

RECRUITING

Fudan University Shanghai Cancer Center, Shanghai

All Listed Sponsors
lead

Fudan University

OTHER