Menu
Recruiting NCT06787183

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

Phase II Interventional Locally Advanced Rectal Cancer With Liver Metastases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Short course radiotherapy, Capecitabine, Oxaliplatin, QL1706.
Who it may be relevant to
Registry conditions: Locally Advanced Rectal Cancer With Liver Metastases. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Interventions

  • Radiation Short course radiotherapy
    CTV 25Gy/5Fx.
  • Drug Capecitabine
    1000mg/m2, d1-14，bid, q3w, 2 cycles.
  • Drug Oxaliplatin
    130mg/m2, d1, q3w, 2 cycles
  • Drug QL1706
    5.0 mg/kg, q3w

Primary outcome measures

  • Progression-free-Survival [Time frame: from enlrollment to 36month]
Secondary outcome measures (3)
  • Toxic reaction rate above 3rd degree [Time frame: from enlrollment to 36month]
  • relapse-free survival [Time frame: from enlrollment to 36month]
  • overall survival [Time frame: from enlrollment to 36month]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 2 centers
  • Fuzhou First General Hospital — Fuzhou
  • Fujian Cancer Hospital — Fuzhou

Identifiers

NCT: NCT06787183 · SCARLET

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗