Different-Dose Short-Course Radiotherapy With CAPOX, PD-1 Blockade, and IL-2 in Locally Advanced Rectal Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized phase II study compares two dosing strategies of short-course radiotherapy given before or with systemic immunochemotherapy for locally advanced rectal cancer. Both arms receive CAPOX, a PD-1 monoclonal antibody, and interleukin-2, with the aim of increasing complete tumor response and enabling organ preservation. The trial builds on prior single-arm results suggesting enhanced activity with the combination therapy and seeks robust evidence for optimal radiotherapy intensity within a multimodal neoadjuvant strategy. Outcomes of interest include complete response rates, surgical resection feasibility, safety, and preliminary long-term disease control. Eligible participants are adults with localized, non-metastatic rectal cancer appropriate for intensive neoadjuvant treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male and female patients aged 18 to 70 years.
2. Histologically confirmed rectal adenocarcinoma with the distal margin of the tumor located within 12 cm of the anal verge.
3. MRI-based clinical stage T3-T4 or any T with lymph node-positive (N+) disease.
4. 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.
5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.

Exclusion Criteria:

1. Metastatic disease (Stage IV).
2. Recurrent rectal cancer.
3. Concurrent active bleeding, perforation, or other complicated conditions requiring emergency surgery.
4. Prior systemic anticancer therapy for rectal cancer.
5. Presence of another non-colorectal neoplastic disease at the same time.
6. Patients with any active autoimmune disease or a history of autoimmune disease requiring steroids or immunomodulatory therapy.
7. Patients with interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases (e.g., diabetes mellitus, hypertension, pulmonary fibrosis, and acute pneumonitis).
8. 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.
9. Prior treatment with anti-programmed death-1 (PD-1)/PD-L1 antibody or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody.
10. Pregnant or breastfeeding women.
11. Known or tested positive for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS).
12. Known or suspected history of allergy to any of the relevant drugs used in the study.

Where it's running

• Jiangsu Province Hospital
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Yueming Sun
• Email: jssym@vip.sina.com
• Phone: 025-68306026

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Short-course vs long-course radiotherapy followed by the PD-L1 drug adebrelimab plus CAPEOX before surgery for locally advanced rectal cancer

  This trial will test whether adding the PD‑L1 drug adebrelimab to either short‑course or long‑course radiotherapy plus CAPEOX chemotherapy before surgery helps patients with locally advanced, MSS rectal cancer.

  Recruiting Phase 2 Shandong Provincial Hospital · Jinan, Shandong · NCT07284992

• β-hydroxybutyrate with short-course radiotherapy, immunotherapy and CAPEOX before surgery for locally advanced rectal cancer

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  Recruiting Phase 2 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Wuhan, Hubei · NCT07239466

• Long-course versus short-course radiotherapy before immunotherapy and total neoadjuvant therapy for locally advanced rectal cancer

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  Recruiting Phase 3 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Wuhan, Hubei · NCT07113275

• Node-sparing radiotherapy with chemotherapy and PD-1 inhibitor for rectal cancer

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  Recruiting Phase 2/3 Sixth Affiliated Hospital, Sun Yat-sen University · Guangzhou, Guangdong · NCT06958432

• Combining long-course radiotherapy, chemotherapy, and PD-1 inhibitor for high-risk rectal cancer

  This study is testing a new treatment plan that combines radiation, chemotherapy, and a PD-1 inhibitor to see if it helps people with high-risk rectal cancer do better than with standard treatments.

  Recruiting Phase 2 Sixth Affiliated Hospital, Sun Yat-sen University · Guangzhou, Guangdong · NCT06923345

• Combining adebrelimab with radiotherapy and chemotherapy for advanced rectal cancer treatment

  This study is testing if combining a new drug called adebrelimab with radiation and chemotherapy can help people with advanced rectal cancer have better surgery results and improve their health.

  Recruiting Phase 2 Shandong Provincial Hospital · Jinan, Shandong · NCT06765616

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.