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

Last updated: February 28, 2026
Sponsor: Fujian Cancer Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Rectal Cancer

Digestive System Neoplasms

Colon Cancer

Treatment

Capecitabine

QL1706

Oxaliplatin

Clinical Study ID

NCT06787183
SCARLET
  • Ages 18-75
  • All Genders

Study 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 Criteria

Inclusion

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

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 andcervical carcinoma in situ.

  4. Uncontrolled epilepsy, central nervous system disorders, or history of psychiatricdisorders that, in the opinion of the investigator, may interfere with signing theinformed consent form or affect patient compliance with oral medication.

  5. Clinically significant (i.e., active) cardiac disease, such as symptomatic coronaryartery disease, New York Heart Association (NYHA) Class II or greater congestiveheart 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-termsteroid 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 thefollowing 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 timesthe upper limit of normal; serum total bilirubin <1.5 times the upper limit ofnormal; 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 Design

Total Participants: 42
Treatment Group(s): 4
Primary Treatment: Capecitabine
Phase: 2
Study Start date:
December 01, 2025
Estimated Completion Date:
December 01, 2029

Connect with a study center

  • Fujian Cancer Hospital

    Fuzhou, Fujian 350014
    China

    Site Not Available

  • Fujian Cancer Hospital

    Fuzhou 1810821, Fujian 1811017 350014
    China

    Active - Recruiting

  • Fuzhou First General Hospital

    Fuzhou 1810821, Fujian 1811017 350004
    China

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.