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

Recruiting now · Phase 2

Conditions studied: Rectal Cancer, Radiotherapy

In brief

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 facts

Study ID

NCT07646639

Run by

The First Affiliated Hospital with Nanjing Medical University

People needed

122

Starts

2026-05-20

Expected to finish

2030-12-31

Last updated by the study team

2026-06-15

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 total bilirubin <=1.5 x upper normal limit (UNL); aspartate aminotransferase <=2.5 x UNL; alanine aminotransferase <=2.5 x UNL; serum creatinine <=1.5 x UNL.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.

You may not qualify if…

• Metastatic disease (Stage IV).
• Recurrent rectal cancer.
• Concurrent active bleeding, perforation, or other complicated conditions requiring emergency surgery.
• Prior systemic anticancer therapy for rectal cancer.
• Presence of another non-colorectal neoplastic disease at the same time.
• Patients with any active autoimmune disease or a history of autoimmune disease requiring steroids or immunomodulatory therapy.
• Patients with interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases (e.g., diabetes mellitus, hypertension, pulmonary fibrosis, and acute pneumonitis).
• Any unresolved grade >=2 toxicity (according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0) resulting from previous treatment, except for anemia, alopecia, and skin hyperpigmentation.
• Prior treatment with anti-programmed death-1 (PD-1)/PD-L1 antibody or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody.
• Pregnant or breastfeeding women.
• Known or tested positive for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS).
• Known or suspected history of allergy to any of the relevant drugs used in the study.

Where it is running

• Jiangsu Province Hospital — Nanjing, Jiangsu, China (enrolling)

Full record on ClinicalTrials.gov

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