Short-Course RT with CAPOX and Tislelizumab vs Long-Course RT with Tislelizumab for 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 phase 2 trial compares two radiotherapy strategies combined with CAPOX chemotherapy and tislelizumab in patients with locally advanced rectal cancer. Participants are randomized to receive modified short-course radiotherapy or conventional long-course chemoradiotherapy, both with CAPOX and tislelizumab, to assess complete tumor response rates and safety. Eligibility includes adults 18–75 with MRI-confirmed T3-4 or node-positive disease, limited distance from the anal verge, MSS/pMMR status, and adequate organ function. Primary aim is to identify which radiotherapy approach yields higher complete response while maintaining tolerable toxicity. The study is conducted at three cancer centers in Fujian, China, led by Fujian Cancer Hospital.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18-75 years, any gender.
* Pathologically confirmed rectal adenocarcinoma.
* Baseline MR stage T3-4/N+.
* Distance from anal verge ≤12cm.
* No distant metastasis.
* Karnofsky Performance Status ≥70.
* Adequate organ function, no contraindications to surgery, radiotherapy, or immunotherapy.
* Microsatellite/mismatch repair status MSS/pMMR.
* No prior chemotherapy or any other anti-tumor treatment before inclusion.
* No prior immunotherapy.
* Ability to comply with the study protocol during the study period.
* Signed written informed consent.

Exclusion Criteria:

* Pregnant or lactating women.
* Pathological diagnosis of signet ring cell carcinoma.
* History of other malignancies within the past 5 years, except cured skin cancer and cervical carcinoma in situ.
* Uncontrolled epilepsy, central nervous system disorders, or history of psychiatric disorders that, in the opinion of the investigator, may interfere with signing the informed consent form or affect patient compliance with oral medication.
* Clinically significant (i.e., active) cardiac disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) Class II or greater congestive heart failure, or significant arrhythmias requiring drug intervention (see Appendix 12), or history of myocardial infarction within the past 12 months.
* Organ transplant recipients requiring immunosuppressive therapy and long-term steroid users.
* Patients with autoimmune diseases.
* Severe uncontrolled recurrent infections or other severe uncontrolled comorbidities.
* Subjects with baseline hematological and biochemical parameters not meeting the following criteria: hemoglobin ≥90g/L; absolute neutrophil count (ANC) .≥1.5×10\^9/L; platelets ≥100×10\^9/L; ALT, AST ≤2.5 times the upper limit of normal; ALP

  ≤2.5 times the upper limit of normal; serum total bilirubin \<1.5 times the upper limit of normal; serum creatinine \<1 times the upper limit of normal; serum albumin ≥30g/L.
* Known deficiency of dihydropyrimidine dehydrogenase (DPD).
* Allergy to any investigational drug components.

Where it's running

• Fujian Cancer Hospital
  Fuzhou, Fujian, China Recruiting
• The Second Hospital of Longyan
  Longyan, Fujian, China Not yet recruiting
• Jinjiang Municipal Hospital
  Quanzhou, Fujian, China Not yet recruiting

Study contacts

• Principal investigator: Jiunluan Li, MD — Fujian Cancer Hospital
• Study coordinator: Jinluan Li, MD
• Email: lijinluan@fjmu.edu.cn
• Phone: 15159628678

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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.