Short-course pelvic radiotherapy with CAPOX chemotherapy plus QL1706 immunotherapy for rectal cancer that has spread to the liver

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 interventional trial gives patients short-course pelvic radiotherapy together with systemic CAPOX (capecitabine plus oxaliplatin) and QL1706, a bifunctional PD‑1/CTLA‑4 immune checkpoint inhibitor, to treat rectal cancer with synchronous liver metastases. Eligible adults (18–75 years) must have pathologically confirmed rectal cancer, MSS/pMMR tumors, a Karnofsky Performance Status ≥70, adequate organ function, and no prior anti-tumor or immunotherapy. The study will monitor tumor response, conversion to resectability of the primary tumor and liver metastases, and safety/tolerability of the combination. The trial is conducted at Fujian Cancer Hospital and Fuzhou First General Hospital in Fuzhou, Fujian, China.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 18-75 years, any gender.
2. Pathologically confirmed rectal cancer with liver metastases (stage M1).
3. Karnofsky Performance Status ≥70.
4. Adequate organ function, no contraindications to radiotherapy, or immunotherapy.
5. Microsatellite/mismatch repair status MSS/pMMR.
6. No prior chemotherapy or any other anti-tumor treatment before inclusion.
7. No prior immunotherapy.
8. Ability to comply with the study protocol during the study period.
9. Signed written informed consent.

Exclusion Criteria:

1. Pregnant or lactating women.
2. Pathological diagnosis of signet ring cell carcinoma.
3. History of other malignancies within the past 5 years, except cured skin cancer and cervical carcinoma in situ.
4. 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.
5. 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.
6. Organ transplant recipients requiring immunosuppressive therapy and long-term steroid users.
7. Patients with autoimmune diseases.
8. Severe uncontrolled recurrent infections or other severe uncontrolled comorbidities.
9. 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.
10. Known deficiency of dihydropyrimidine dehydrogenase (DPD).
11. Allergy to any investigational drug components.

Where it's running

• Fujian Cancer Hospital
  Fuzhou, Fujian, China Recruiting
• Fuzhou First General Hospital
  Fuzhou, Fujian, China Not yet recruiting

Study contacts

• Study coordinator: Hui Li, MD
• Email: lihui70105@126.com
• Phone: +8613600855801

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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.