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NCT Number: NCT06787183

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

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.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fujian Cancer Hospital, Fuzhou, Fujian, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 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.

Treatment and study plan

Short Course Radiotherapy

Radiation

CTV 25Gy/5Fx.

Capecitabine

Drug

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

Oxaliplatin

Drug

130mg/m2, d1, q3w, 2 cycles

QL1706

Drug

5.0 mg/kg, q3w

Primary outcomes

  1. Progression-free-Survival

    Time frame: from enlrollment to 36month

Secondary outcomes

  1. Toxic reaction rate above 3rd degree

    Time frame: from enlrollment to 36month

  2. relapse-free survival

    Time frame: from enlrollment to 36month

  3. overall survival

    Time frame: from enlrollment to 36month

Study contacts

Contact information is provided by the study sponsor or research team.

Hui Li, MD

CONTACT

[email protected]

+8613600855801

Jinluan Li, MD

CONTACT

[email protected]

+86 15159628678

Sponsors and collaborators

Lead sponsor

Fujian Cancer Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2029
First posted
Jan 22, 2025
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.