Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07646639
PHASE2

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

Sponsor: The First Affiliated Hospital with Nanjing Medical University

View on ClinicalTrials.gov

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.

Official title: Different-Dose Short-Course Radiotherapy Plus CAPOX, Anti-PD-1 Antibody and Interleukin-2 for Locally Advanced Rectal Cancer: A Single-Centre, Prospective, Randomised Phase II Trial

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

122

Start Date

2026-05-20

Completion Date

2030-12-31

Last Updated

2026-06-15

Healthy Volunteers

No

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)

Locations (1)

Jiangsu Province Hospital

Nanjing, Jiangsu, China