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

Sponsor
The First Affiliated Hospital with Nanjing Medical University
Study ID
NCT07646639
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Sintilimab + IL-2 Combined with CAPOX — DRUG
    Enhanced immuno-chemotherapy cocktail.
  • Short-course low-dose radiotherapy — RADIATION
    A short-course radiotherapy (SCRT, 10Gy/5f)
  • Short-course standard-dose radiotherapy — RADIATION
    A short-course radiotherapy (SCRT, 25Gy/5f)

Study Details

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.

Key Dates

First listed
Jun 15, 2026
Start date
May 20, 2026
Status verified
Mar 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2030

Study Design

Enrollment
122 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Short-course standard-dose radiotherapy, IL-2 and Sintilimab Combined with CAPOX
  • Experimental: Short-course low-dose radiotherapy, IL-2 and Sintilimab Combined with CAPOX

Primary Outcome Measure

Complete remission [ Time Frame: Two years ]

Central Contacts

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