Liver surgery combo fails to show clear survival edge in advanced colorectal cancer
NCT ID NCT02738606
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at whether removing liver tumors with surgery, along with chemotherapy, helps people with colorectal cancer that has spread to the liver and lungs live longer compared to chemotherapy alone. The trial was stopped early after enrolling only 29 participants. The results did not show a clear survival benefit from adding surgery, so the best approach remains uncertain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
29 people
The number who actually took part.
- Started
-
Sep 2016
- Finished
-
Dec 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients with synchronous or metachronous diagnosis of resectable liver metastases by computed tomography (CT) or magnetic resonance imaging (MRI) of the abdomen * Patients requiring percutaneous or intraoperative ablation of liver metastases \< 2 cm in size are eligible * Patients who underwent prior liver resection or ablation for colorectal liver metastases are eligible * Patients previously treated with systemic chemotherapy and/or biologic agents for colorectal cancer are eligible * The primary tumor in the colon or rectum may be intact or resected * Low-volume lung metastases are defined as solid pulmonary nodules \< 2 cm with non-spiculated contours, no benign-appearing calcifications, and =\< 14 in number, diagnosed by computed tomography of the chest or positron emission tomography (PET) * Lung metastases will be unresectable due to anatomic location, distribution, or patients' comorbidities, as determined by review of imaging by a faculty member in the Department of Thoracic \& Cardiovascular Surgery * Patients must sign a study-specific consent form * Patients will undergo CT imaging of the chest, abdomen, and pelvis to evaluate lung and liver metastases within 60 days of registration; for patients who cannot tolerate CT contrast or have hepatic steatosis that reduces the sensitivity of CT, MRI of the liver will be performed Exclusion Criteria: * Radiographic evidence of disease other than liver and lungs, with the exception of mediastinal lymph nodes \< 2 cm and hepatoduodenal ligament lymphadenopathy, diagnosed by computed tomography, magnetic resonance imaging, or positron emission tomography * Serum bilirubin \>= 2 mg/dL * Platelet count \< 50,000/uL * Eastern Cooperative Oncology Group (ECOG) performance status of 3-4 * Patient refusal to participate in randomization * Pregnant women are excluded from this study * Planned stereotactic body radiation therapy (SBRT) for the pulmonary metastases
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Metastatic colorectal carcinoma are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
M D Anderson Cancer Center
Houston, Texas, 77030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a new drug combo revive the immune System's attack on resistant cancers?
- Can a new drug combo shrink metastatic colorectal tumors?
- Can a new blood test spot colorectal cancer return earlier?
- Can a pill boost the immune system to fight Hard-to-Treat cancers?
- Experimental drug combo targets Hard-to-Treat GI cancers
- Double immunotherapy plus liver blockade targets eye cancer that spreads