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Different-Dose SCRT Plus CAPOX, PD-1 Blockade and IL-2 in LARC

NCT07646639 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2026-06-15

No results posted yet for this study

Summary

This prospective, randomized phase II trial is designed to evaluate whether low-dose short-course radiotherapy differs from common-dose short-course radiotherapy in terms of efficacy when both regimens are sequentially combined with CAPOX, a PD-1 monoclonal antibody, and interleukin-2 (IL-2) in patients with locally advanced rectal cancer. The study is based on findings from our previous single-center, single-arm PRIDE01 study, in which neoadjuvant short-course radiotherapy followed by systemic chemoimmunotherapy and IL-2 demonstrated encouraging antitumor activity relative to historical short-course radiotherapy-based approaches. The current trial aims to provide more robust clinical evidence regarding the potential role of low-dose radiotherapy combined with IL-2 as a sensitization strategy in multimodal neoadjuvant therapy. By comparing complete response rates between the two radiotherapy dose levels, this study may help define an optimized neoadjuvant approach and support future organ-preservation strategies for patients with locally advanced rectal cancer.

Conditions

Interventions

DRUG

Sintilimab + IL-2 Combined with CAPOX

Enhanced immuno-chemotherapy cocktail.

RADIATION

Short-course low-dose radiotherapy

A short-course radiotherapy (SCRT, 10Gy/5f)

RADIATION

Short-course standard-dose radiotherapy

A short-course radiotherapy (SCRT, 25Gy/5f)

Sponsors & Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2026-05-20
Primary Completion
2028-12-31
Completion
2030-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT07646639 on ClinicalTrials.gov