Actively Recruiting
Localized Treatment Versus Palliative Chemotherapy in CRC Patients With 10 or More CRLM
Led by Sun Yat-sen University · Updated on 2025-05-30
117
Participants Needed
1
Research Sites
284 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to investigate the effectiveness of localized interventions in improving the 5-year survival rate for colorectal cancer patients with ≥10 liver metastases. We aim to answer the following question: Can localized interventions, including surgery and/or ablation and/or stereotactic body radiotherapy (SBRT), enhance the 5-year survival rate compared to palliative chemotherapy alone in patients with ≥10 colorectal liver metastases (CRLM)? Participants in this study, who have achieved disease control through chemotherapy, will undergo either localized interventions (surgery and/or ablation and/or SBRT) or receive palliative chemotherapy alone. Researchers will compare the survival outcomes between these groups to determine the potential benefits of localized interventions for patients with ≥10 CRLM.
CONDITIONS
Official Title
Localized Treatment Versus Palliative Chemotherapy in CRC Patients With 10 or More CRLM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed colorectal adenocarcinoma
- Liver metastases confirmed by imaging or pathology with no extrahepatic metastasis except possibly small lung or lymph node lesions under 10mm
- Disease control (partial response or stable disease) after at least 8 cycles of systemic chemotherapy
- Confirmation by expert liver surgeons that 10 or more liver metastases can be treated with surgery, ablation, and/or SBRT to achieve no evidence of disease
- Primary colorectal tumor can be cured by surgery
- Normal blood, liver, and kidney function at baseline
- Child-Pugh grade A liver function
- ECOG performance status 0-1
- Able to tolerate further surgery and chemotherapy
- Life expectancy longer than 3 months
- Signed informed consent
- Willing and able to be followed until death, study end, or termination
You will not qualify if you...
- Presence of extrahepatic metastasis or primary tumor not suitable for curative surgery
- Severe arterial embolism or ascites
- Bleeding disorders or coagulation problems
- Hypertensive crisis or hypertensive encephalopathy
- Severe uncontrolled systemic conditions such as infections or diabetes
- Serious cardiovascular diseases including recent stroke, heart attack, unstable angina, heart failure, or arrhythmias requiring medication
- Central nervous system diseases such as brain tumors, uncontrolled epilepsy, brain metastases, or history of stroke
- Other cancers diagnosed within last 5 years except certain skin or cervical cancers
- Pregnant or breastfeeding women
- Women of childbearing potential not using or refusing effective non-hormonal contraception, or men with reproductive potential
- Unable or unwilling to follow study protocol
- Other diseases or conditions causing functional impairment or high risk of treatment complications
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
Y
Yuhong Li, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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