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Short-course Radiotherapy Combined With Retlirafusp Alfa and CAPOX Chemotherapy as Neoadjuvant Therapy for Locally Advanced Rectal Cancer: A Prospective, Single-arm, Phase II Clinical Study

NCT07663071 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2026-06-23

No results posted yet for this study

Summary

This study aims to evaluate the efficacy and safety of neoadjuvant short-course radiotherapy combined with Retlirafusp alfa and CAPOX chemotherapy in the treatment of locally advanced rectal cancer. This is a prospective, single-arm, phase II clinical trial planned to enroll 44 patients with locally advanced rectal cancer. The primary endpoint is the complete response rate, and secondary endpoints include objective response rate, pathological complete response rate, event-free survival, and overall survival, with the goal of providing evidence to optimize clinical treatment decisions.

Conditions

  • Rectal Cancer Patients

Interventions

DRUG

Short-course radiotherapy combined with Retlirafusp alfa and CAPOX chemotherapy

Short-course radiotherapy + Retlirafusp alfa + CAPOX chemotherapy for 1 cycle, followed by Retlirafusp alfa + CAPOX chemotherapy for 3 cycles. Cycle 1: Retlirafusp alfa: 1800 mg or 30 mg/kg, IV infusion over 30-60 min, D1, q3w; administered at least 30 min before chemotherapy. Oxaliplatin: 130 mg/m², IV infusion over ≥2 h, D1, q3w. Capecitabine: 1000 mg/m², PO, twice daily (total 2000 mg/m²/day) for 14 days, q3w. Short-course radiotherapy: 25 Gy in 5 fractions, D2-D6. Cycles 2-4: Retlirafusp alfa: 1800 mg or 30 mg/kg, IV infusion over 30-60 min, D1, q3w. Oxaliplatin: 130 mg/m², IV infusion over ≥2 h, D1, q3w. Capecitabine: 1000 mg/m², PO, twice daily (total 2000 mg/m²/day) for 14 days, q3w. Efficacy evaluation is performed after cycles 2 and 4. Patients are reassessed 2-4 weeks after the last treatment. Those achieving clinical complete response (cCR) may opt for watch-and-wait (W\&W). Non-cCR patients (near-CR, PR, or SD) are recommended to undergo total mesorectal excision (

Sponsors & Collaborators

  • Harbin Medical University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-27
Primary Completion
2028-05-27
Completion
2029-05-27

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07663071 on ClinicalTrials.gov