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

NCT06208371 | Recruiting Phase 3

• 1 other identifier: DECIDE-CRLM-10
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

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 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

Colorectal Neoplasms Malignant

Keywords

Colorectal liver metastases; Overall survival; Locoregional treatment; Palliative chemotherapy; Randomized Clinical Study

Outcome Measures

Primary Outcomes (1)

• Five-year survival rate

  The proportion of patients who are still alive five years following diagnosis

  Assessed five-year following diagnosis

Secondary Outcomes (5)

• Median Progression-Free Survival

  Assessed throughout the study duration (5 years)

• Median Overall Survival

  Assessed throughout the study duration (5 years)

• Cumulative Incidence of Liver Progression Events

  Assessed throughout the study duration (5 years)

• Cumulative Incidence of Extrahepatic Progression Events

  Assessed throughout the study duration (5 years)

• Treatment-related Adverse Events

  Assessed throughout the study duration (5 years)

Study Arms (2)

Liver-localized treatment group

EXPERIMENTAL

Participants in this group will undergo liver-localized interventions, which may include surgical resection and/or ablation therapy and/or SBRT, aiming to achieve NED.

Procedure: Surgical resection and/or ablation therapy and/or SBRT

Palliative chemotherapy only group

ACTIVE COMPARATOR

Participants in this group will receive standard palliative chemotherapy. The focus is on managing symptoms and controlling the progression of the disease.

Drug: Palliative Chemotherapy

Interventions

Surgical resection and/or ablation therapy and/or SBRT PROCEDURE

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

Liver-localized treatment group

Palliative Chemotherapy DRUG

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.

Palliative chemotherapy only group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• Histologically confirmed colorectal adenocarcinoma.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Central Study Contacts

Yuhong Li, PhD

CONTACT

87342487; liyh@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The participants who meet the inclusion criteria will be grouped using a stratified block randomization method. The stratification factors include the entire RAS/BRAF gene (wild-type vs. mutated), the number of liver metastases (10-20 vs. \>20), and the location of the primary lesion (left vs. right). The random grouping of participants will be accomplished using our center's Interactive Web Response System (IWRS). The participants will be randomly assigned to either the liver-localized treatment group or the palliative chemotherapy group in a 2:1 ratio.

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: January 17, 2024
• Study Start: January 15, 2024
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2029
• Last Updated: May 30, 2025

Record last verified: 2025-05

Locations

CN (1)