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Different-Dose SCRT Plus CAPOX, PD-1 Blockade and IL-2 in LARC
Sponsor: The First Affiliated Hospital with Nanjing Medical University
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
Conditions
Interventions
Sintilimab + IL-2 Combined with CAPOX
Enhanced immuno-chemotherapy cocktail.
Short-course low-dose radiotherapy
A short-course radiotherapy (SCRT, 10Gy/5f)
Short-course standard-dose radiotherapy
A short-course radiotherapy (SCRT, 25Gy/5f)
Locations (1)
Jiangsu Province Hospital
Nanjing, Jiangsu, China