Actively Recruiting
LDRT Combined With Immunochemotherapy for Colorectal Cancer With Liver Metastasis
Led by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University · Updated on 2026-04-03
9
Participants Needed
2
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
In recent years, growing evidences have demonstrated promising synergistic antitumor effects of radiotherapy combined with immunotherapy. More over, LDRT may enhance the antitumor effect of immunotherapy by altering the tumor immune microenvironment (TIME) and adjusting the immune response. In this study, we will explore the safety and feasibility of LDRT and immunochemotherapy in liver metastatic colorectal cancer. 9-18 participants will be enrolled in this study. All will take part at Daping Hospital, Army Medical University.
CONDITIONS
Official Title
LDRT Combined With Immunochemotherapy for Colorectal Cancer With Liver Metastasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years old.
- Histopathologically confirmed MSS/pMMR adenocarcinoma of the colon or rectum.
- Clinical baseline stage of rectal cancer assessed by MRI/CT/Transrectal ultrasound as T3-4Nx or TXN1-2.
- Presence of simultaneous liver metastasis confirmed by imaging.
- No previous antitumor treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate cardiac function with left ventricular ejection fraction greater than 50%.
- Adequate liver function with total serum bilirubin ≤ 1.5 times upper limit of normal, and ALT or AST ≤ 2.5 times upper limit of normal.
- Adequate kidney function with serum creatinine ≤ 1.5 times upper limit of normal or glomerular filtration rate > 60 ml/min.
- Adequate blood counts: white blood cells ≥ 4.0 x 10^9/L, neutrophils ≥ 1.5 x 10^9/L, hemoglobin ≥ 90 g/L, platelets ≥ 100 x 10^9/L.
- Signed informed consent and good compliance.
You will not qualify if you...
- Distant metastases outside the liver.
- Body mass index less than 18.5 kg/m² or weight loss ≥ 10% in the past 6 months.
- Prior receipt of investigational drugs, concurrent enrollment in other clinical trials except observational studies, or prior anti-tumor/live vaccines.
- Active or history of autoimmune diseases, or liver diseases including HBV or HCV infection and liver cirrhosis.
- History of immunodeficiency, positive HIV test, or history of organ/bone marrow transplantation.
- History of heart disease within 6 months including congestive heart failure, acute myocardial infarction, severe angina, coronary artery bypass grafting, or cardiac insufficiency with LVEF < 50%.
- Presence of a second primary malignancy or history of other malignancies within 5 years except certain skin, cervical, or bladder cancers.
- Pregnant or breastfeeding women.
- Any clinical or laboratory abnormalities or compliance issues making participation unsuitable as judged by the investigator.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Army Medical Center
Chongqing, Chongqing Municipality, China, 400042
Actively Recruiting
2
Daping Hospital, Army Medical University
Chongqing, Chongqing Municipality, China, 400042
Active, Not Recruiting
Research Team
C
Chuan Chen, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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