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

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of short-course radiation, chemotherapy (CAPOX), and an immunotherapy drug (QL1706) for people with rectal cancer that has spread to the liver. The goal is to see if this combined approach can shrink the cancer and improve outcomes. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with rectal cancer that has spread to the liver (stage M1) - Your cancer has a specific genetic trait called MSS or pMMR - You have not received any prior chemotherapy or other cancer treatments for this condition - You are reasonably fit (Karnofsky score 70 or above) and your organs are functioning adequately **You may NOT be eligible if...** - You are pregnant or breastfeeding - Your cancer is of a type called signet ring cell carcinoma - You have had another cancer in the past 5 years (except for certain cured skin cancers) - You have an autoimmune disease (a condition where the immune system attacks the body) or received an organ transplant requiring ongoing immune-suppressing drugs - You have significant heart problems such as heart failure or a recent heart attack - You have active uncontrolled infections or severe other illnesses Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

View Full Details on ClinicalTrials.gov

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NCT06787183