RecruitingPhase 3NCT06208371

Localized Treatment Versus Palliative Chemotherapy in CRC Patients With 10 or More CRLM

The DECIDE-CRLM-10 Randomized Controlled Study: Comparison of Chemotherapy Combined With Localized Treatment for Liver Metastases Versus Palliative Chemotherapy Alone in Colorectal Patients With 10 or More Liver Metastases

Sponsor

Sun Yat-sen University

Enrollment

117 participants

Start Date

Jan 15, 2024

Study Type

INTERVENTIONAL

Conditions

Colorectal Neoplasms Malignant

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 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.

Eligibility

Min Age: 18 Years

Inclusion Criteria13

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 Criteria12

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.

Interventions

PROCEDURESurgical resection and/or ablation therapy and/or SBRT

Participants may receive surgical resection and/or ablation therapy and/or stereotactic body radiotherapy

DRUGPalliative Chemotherapy

Participants in this group may continue the original systemic chemotherapy regimen. Patients with tumor control after 10-12 cycles can either transition to maintenance treatment or temporarily suspend treatment until disease progression, at which point they switch to a second-line treatment regimen.The selection of second-line and subsequent treatment regimens follows CSCO guidelines and clinical practices.