NCT07183865View on ClinicalTrials.gov

Hypofractionated Radiotherapy Combined With NALIRIF, PD-1 Antibody in Locally Recurrent Rectal Cancer(NOVELTY-R)

PHASE2RecruitingINTERVENTIONAL
Enrollment

44

Participants

Timeline

Start Date

March 9, 2025

Primary Completion Date

March 9, 2030

Study Completion Date

March 9, 2030

Conditions
Locally Recurrent Rectal Cancer
Interventions
RADIATION

radiotherapy

25-40Gy/5Fx or 15-30Gy/5Fx (previous pelvic radiation) for pelvic recurrence. 25-50GY/5Fx for all metastasis tumors. Dose Constraints are based on SABR-COMET 10 trial.

DRUG

Irinotecan Hydrochloride Liposome

70mg/m2 (UGT1A1\*28 6/6) or 55mg/m2 (UGT1A1\*28 6/7), IV, q2w

DRUG

5-FU

400 mg/m\^2 bolus over 2 hours followed by 2400 mg/m\^2 continuous infusion over 48 hours d1, q2w

DRUG

Leucovorin

400mg/m2, IV, q2w

DRUG

SG001

240mg, IV, q2w

DRUG

C225

500 mg/m2, IV, q2w

DRUG

Bevacizumab

5mg/kg, IV, q2w

Trial Locations (1)

200032

RECRUITING

Fudan University Shanghai Cancer Center, Shanghai

All Listed Sponsors
lead

Fudan University

OTHER