Recruiting

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

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What is being tested

Surgical resection and/or ablation therapy and/or SBRT

+ Palliative Chemotherapy

ProcedureDrug
Who is being recruted

Colonic Diseases+8

+ Colonic Neoplasms

+ Digestive System Diseases

Over 18 Years
+25 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: January 2024
See protocol details

Summary

Principal SponsorSun Yat-sen University
Study ContactYuhong Li, PhD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 15, 2024

Actual date on which the first participant was enrolled.

This clinical trial is exploring treatment options for patients who have colorectal cancer with at least 10 liver metastases. Colorectal cancer often spreads to the liver, and when this happens, it can be challenging to treat effectively. While surgery is a common way to remove cancer from the liver, only a small percentage of patients qualify for such procedures. This study aims to determine if combining surgery or other localized treatments with chemotherapy can improve survival rates over chemotherapy alone for patients who have many liver metastases. This research is important because it might offer new hope and better outcomes for patients who currently have limited treatment options. Participants in the study will first receive chemotherapy to control the cancer in their liver. After achieving disease control, they will be randomly assigned to receive either additional localized treatment, such as surgery, ablation, or stereotactic body radiotherapy (SBRT), or continue with chemotherapy alone. The study will monitor the participants over five years to see if those who receive the localized treatments live longer than those who only receive chemotherapy. This trial hopes to provide new evidence on the effectiveness of combining local interventions with chemotherapy in improving survival rates in patients with numerous liver metastases.

Official TitleThe 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
NCT06208371
Principal SponsorSun Yat-sen University
Study ContactYuhong Li, PhD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

117 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Colonic DiseasesColonic NeoplasmsDigestive System DiseasesDigestive System NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsIntestinal DiseasesIntestinal NeoplasmsNeoplasmsNeoplasms by SiteColorectal Neoplasms

Criteria

13 inclusion criteria required to participate
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.

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12 exclusion criteria prevent from participating
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.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Sun Yat-sen Cancer Center

Guangzhou, ChinaOpen Sun Yat-sen Cancer Center in Google Maps
Recruiting
One Study Center