NCT07183865

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

Hypofractionated Radiotherapy Combined With Irinotecan Hydrochloride Liposome, 5-FU, Leucovorin, PD-1 Antibody and Target Therapy in Locally Recurrent Rectal Cancer(NOVELTY-R)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, single arm, phase 2 study. The study is to evaluate the activity of combination therapy of hypofractionated radiotherapy, Irinotecan Hydrochloride Liposome plus 5-FU and leucovorin (NALIRIF), Anti-PD1 and target therapy in patients with locally recurrent rectal cancer (LRRC). The inclusion LRRC patients were failed to oxaliplatin treatment in prior chemotherapy or chemoradiotherapy due to toxicity or progression. Patients will receive 25-40Gy/5Fx irradiation or 15-30Gy/5Fx reirradiation for pelvic recurrence, 25-50Gy/5Fx irradiation for all metastasis sites, and 8 cycles of NALIRIF + anti-PD1 + target therapy, followed by multidisciplinary team (MDT) for decision: radical surgery, sustained system +/- local treatment of non resection. The primary endpoint was local objective response rate. Secondary endpoints were extrapelvic objective response rate, complete response rate, R0 resection rate, duration of response, progression-free survival, overall survival, and safety and tolerability of the treatment.

Conditions

• Locally Recurrent Rectal Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-03-09
• Primary completion: 2030-03-09
• Completion: 2030-03-09
• First posted: 2025-09-19
• Last updated: 2025-09-19

Locations

1 site across 1 country: China