Status:
RECRUITING
Localized Treatment Versus Palliative Chemotherapy in CRC Patients With 10 or More CRLM
Lead Sponsor:
Sun Yat-sen University
Conditions:
Colorectal Neoplasms Malignant
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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...
Detailed Description
Colorectal cancer is one of the most common malignant tumors, ranking second globally in cancer-related mortality. In recent years, both the incidence and mortality rates of colorectal cancer in China...
Eligibility Criteria
Inclusion
- Age ≥ 18 years.
- Histologically confirmed colorectal adenocarcinoma.
- Baseline imaging (CT, MRI, or PET/CT as necessary) or pathological confirmation of liver metastasis, with no extrahepatic metastasis (consideration for inclusion may be given to lesions with a diameter less than 10mm in the lungs or lymph nodes if metastasis is difficult to confirm or is suspected).
- Disease control (PR or SD) achieved after a minimum of 8 cycles of systemic chemotherapy.
- Evaluation by a centralized liver surgeon expert group to confirm presence of ≥10 liver metastases, which can be managed through surgery and/or ablation and/or SBRT to achieve NED. Non-resectability is defined as one or more of the following: ① Unable to undergo R0 resection; ② Predicted insufficient remaining liver volume after resection; ③ After resection, none of the three hepatic veins can be preserved, and the preservation of residual liver inflow and outflow and bile ducts cannot be guaranteed, and adjacent two liver segments cannot be preserved.
- Curative surgery possible for the primary colorectal lesion.
- Normal hematological, hepatic, and renal functions at baseline.
- Child-Pugh grade A liver function.
- ECOG performance status 0-1.
- Tolerability to undergo further surgery and chemotherapy.
- Life expectancy \> 3 months.
- Signed written informed consent.
- Willing and able to undergo follow-up until death, study completion, or study termination.
Exclusion
- Definite presence of extrahepatic metastasis and/or primary tumor not amenable to curative surgical resection.
- Severe arterial embolism or ascites.
- Bleeding tendencies or coagulation disorders.
- Hypertensive crisis or hypertensive encephalopathy.
- Severe uncontrollable systemic complications such as infection or diabetes.
- Clinically severe cardiovascular diseases such as cerebrovascular accident (within 6 months before enrollment), myocardial infarction (within 6 months before enrollment), uncontrolled hypertension despite appropriate medical treatment, unstable angina, congestive heart failure (NYHA 2-4), and arrhythmias requiring medication.
- History or physical examination indicating central nervous system diseases (such as primary brain tumor, uncontrollable epilepsy, any brain metastasis, or history of stroke).
- Diagnosis of other malignant tumors within the past 5 years (excluding basal cell carcinoma after radical surgery and/or cervical carcinoma in situ).
- Pregnant or lactating women.
- Women of childbearing potential not using or refusing to use effective non-hormonal contraceptive methods (intrauterine devices, combined barrier contraceptive methods with spermicidal gel, or sterilization) or men with reproductive potential.
- Inability or unwillingness to comply with the study protocol.
- Any other diseases, metastatic lesions causing functional impairment, or suspicious findings in the physical examination indicating possible contraindications for the use of investigational drugs or placing the patient at a high risk of treatment-related complications.
Key Trial Info
Start Date :
January 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2029
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT06208371
Start Date
January 15 2024
End Date
June 30 2029
Last Update
May 30 2025
Active Locations (1)
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1
Sun Yat-sen Cancer Center
Guangzhou, Guangdong, China, 510060