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

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

Trial Details

NCT ID
NCT07646639
Phase
PHASE2
Sponsor
The First Affiliated Hospital with Nanjing Medical University
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • Sintilimab + IL-2 Combined with CAPOX
  • Short-course low-dose radiotherapy
  • Short-course standard-dose radiotherapy
Locations (sample)
  • Nanjing, Jiangsu, China|32.06167,118.77778

Key Eligibility Criteria

  • Male and female patients aged 18 to 70 years.
  • Histologically confirmed rectal adenocarcinoma with the distal margin of the tumor located within 12 cm of the anal verge.
  • MRI-based clinical stage T3-T4 or any T with lymph node-positive (N+) disease.
  • Adequate hematologic, hepatic, and renal function defined as: absolute neutrophil count \>=1.5 x 10\^9/L; platelet count \>=75 x 10\^9/L; serum tot…

For full eligibility, visit ClinicalTrials.gov.

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