RecruitingPhase 2NCT06787183

SCRT(Short Course Radiotherapy) Combined With CAPOX Plus QL1706 for Rectal Cancer Liver Metastases

A Phase II Multicenter Clinical Trail of Efficacy and Safety of Short Course Radiotherapy Combined With CAPOX and PD-1/CTLA-4 Bispecific Antibody QL1706 in Patients With Liver Metastases From Rectal Cancer


Sponsor

Fujian Cancer Hospital

Enrollment

42 participants

Start Date

Dec 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

To enhance the treatment efficacy of rectal cancer liver metastasis through a multidisciplinary approach of radiotherapy, immunotherapy, and chemotherapy, and to provide a new direction for the combination treatment strategy.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria9

  • Age 18-75 years, any gender.
  • Pathologically confirmed rectal cancer with liver metastases (stage M1).
  • Karnofsky Performance Status ≥70.
  • Adequate organ function, no contraindications to 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 Criteria11

  • 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.

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Interventions

RADIATIONShort course radiotherapy

CTV 25Gy/5Fx.

DRUGCapecitabine

1000mg/m2, d1-14,bid, q3w, 2 cycles.

DRUGOxaliplatin

130mg/m2, d1, q3w, 2 cycles

DRUGQL1706

5.0 mg/kg, q3w


Locations(2)

Fuzhou First General Hospital

Fuzhou, Fujian, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

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NCT06787183