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

Sponsor
Fudan University
Study ID
NCT07183865
Phase
PHASE2
Status
Recruiting
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Conditions

  • Locally Recurrent Rectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • radiotherapy — RADIATION
    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.
  • Irinotecan Hydrochloride Liposome — DRUG
    70mg/m2 (UGT1A1\*28 6/6) or 55mg/m2 (UGT1A1\*28 6/7), IV, q2w
  • 5-FU — DRUG
    400 mg/m\^2 bolus over 2 hours followed by 2400 mg/m\^2 continuous infusion over 48 hours d1, q2w
  • Leucovorin — DRUG
    400mg/m2, IV, q2w
  • SG001 — DRUG
    240mg, IV, q2w
  • C225 — DRUG
    500 mg/m2, IV, q2w
  • Bevacizumab — DRUG
    5mg/kg, IV, q2w

Study Details

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.

Key Dates

Start date
Mar 9, 2025
Status verified
Sep 2025
Primary completion
Mar 9, 2030
Completion
Mar 9, 2030

Study Design

Enrollment
44 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm
    Radiotherapy: The enrolled patients will receive 25-40Gy/5Fx irradiation or 15-30Gy/5Fx reirradiation (pelvic radiation history) for pelvic recurrence.All metastasis sites will receive 25-50Gy/5Fx irradiation before or between system therapy cycles. Dose Constraints are based on SABR-COMET 10 trial. System therapy: Patients will receive Irinotecan Hydrochloride Liposome plus 5-FU and leucovorin (NALIRIF), PD-1 antibody, target therapy based on the KRAS/NRAS/BRAF mutation station.

Primary Outcome Measure

Local objective response rate [ Time Frame: up to 1 year ]

Central Contacts