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

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.

Study Overview

• Status: Recruiting
• Conditions: Locally Advanced Rectal Cancer With Liver Metastases
• Intervention / Treatment: Radiation: Short course radiotherapy; Drug: Oxaliplatin; Drug: Capecitabine; Drug: QL1706

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Hui Li, MD; Phone Number: +8613600855801; Email: lihui70105@126.com
• Study Contact Backup: Name: Jinluan Li, MD; Phone Number: +86 15159628678; Email: lijinluan@fjmu.edu.cn

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350014
      • Recruiting
      • Fujian Cancer Hospital
      • Principal Investigator: Hui Li, MD
      • Contact: Hui Li, MD; Phone Number: +8613600855801; Email: lihui770105@126.com
      • Principal Investigator: Jinluan Li, MD
    • Fuzhou, Fujian, China, 350004
      • Not yet recruiting
      • Fuzhou First General Hospital
      • Contact: Xiaobin Huang; Phone Number: 86+13860660665

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Short course radiotherapy combined with CAPOX and QL1706; Two cycles of CAPOX combined with QL1706 were followed by a short course of radiotherapy (CTV 25Gy/5f) and finally two cycles of CAPOX and QL1706.	Radiation: Short course radiotherapy; CTV 25Gy/5Fx.; Drug: Oxaliplatin; 130mg/m2, d1, q3w, 2 cycles; Drug: Capecitabine; 1000mg/m2, d1-14，bid, q3w, 2 cycles.; Drug: QL1706; 5.0 mg/kg, q3w

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression-free-Survival	from enlrollment to 36month

Secondary Outcome Measures

Outcome Measure	Time Frame
Toxic reaction rate above 3rd degree	from enlrollment to 36month
relapse-free survival	from enlrollment to 36month
overall survival	from enlrollment to 36month

Collaborators and Investigators

• Sponsor: Fujian Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: January 16, 2025
• First Submitted That Met QC Criteria: January 16, 2025
• First Posted (Actual): January 22, 2025

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: February 28, 2026
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: CAPOX; short course radiotheraphy; QL1706 (bifunctional PD1/CTLA4 dual blocker)
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Rectal Diseases; Liver Diseases; Neoplastic Processes; Rectal Neoplasms; Neoplasm Metastasis; Liver Neoplasms; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Nucleosides; Uracil; Pyrimidinones; Deoxyribonucleosides; Fluorouracil; Capecitabine; Oxaliplatin
• Other Study ID Numbers: SCARLET

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No