NCT06928584View on ClinicalTrials.gov

Hypofractionated Radiotherapy Plus Immunotherapy Versus Conventional Radiotherapy in Locally Recurrent Rectal Cancer

PHASE2RecruitingINTERVENTIONAL
Enrollment

221

Participants

Timeline

Start Date

March 10, 2025

Primary Completion Date

March 10, 2030

Study Completion Date

March 10, 2030

Conditions
Locally Recurrent Rectal Cancer
Interventions
RADIATION

Conventional Radiotherapy

50Gy/25Fx irradiation or 39Gy/30Fx bid reirradiation (previous pelvic radiation)

DRUG

Capecitabine

1000mg/m2 d1-14 q3w

DRUG

5-fluorouracil

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

Cetuximab

500 mg/m² q2w

DRUG

Bevacizumab

5 mg/kg q2w or 7.5mg/kg q3w

RADIATION

Hypofractionated radiotherapy

25-40Gy/5Fx irradiation or 15-30Gy/5Fx reirradiation (previous pelvic radiation)

DRUG

PD-1 antibody

200mg IV q3w

Trial Locations (1)

200032

RECRUITING

Fudan University Shanghai Cancer Center, Shanghai

All Listed Sponsors
lead

Fudan University

OTHER