Comparing surgery and local treatment for liver metastases from colorectal cancer

Comparison of Hepatectomy and Local Ablation for Resectable Synchronous and Metachronous Colorectal Liver Metastasis (HELARC) ------ a Randomized Controlled Multicenter Clinical Study

This study is testing whether removing both the main colorectal tumor and liver metastases at the same time is better than removing the main tumor and treating the liver tumors with a different method for patients with colorectal cancer that has spread to the liver.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 548 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University (Academic / other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT02886104 on ClinicalTrials.gov

What this trial studies

This study aims to compare two treatment strategies for patients with resectable synchronous and metachronous colorectal liver metastases (CRLM). It evaluates the effectiveness and safety of simultaneous resection of both primary and secondary tumors against the combination of resection of the primary tumor with local ablation of the secondary tumor. The study will assess severe complications and survival rates as primary endpoints. By analyzing these two approaches, the research seeks to determine the optimal treatment strategy for patients with CRLM.

Who should consider this trial

Good fit: Ideal candidates for this study are patients with histologically proven colorectal adenocarcinoma and liver metastases that are resectable and meet specific criteria regarding tumor size and number.

Not a fit: Patients with extra-hepatic metastasis or those with local complications at the time of surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide clearer treatment guidelines that improve survival rates and reduce complications for patients with colorectal liver metastases.

How similar studies have performed: While the treatment of colorectal liver metastases has been explored, this specific comparison of hepatectomy versus local ablation is a novel approach that has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. At least one metastatic adenocarcinoma of liver, histologically proven.
2. At least one adenocarcinoma of colon and/or rectum, histologically proven.
3. No local complication at the time of surgery (no occlusion, no sub-occlusion, no massive hemorrhage, no abscesses or local invasion).
4. No extra-hepatic metastasis.
5. Extra-hepatic disease (EHD) suitable for hepatectomy, liver ablation and anesthesia as long as all sites of EHD disease are radically treated.
6. All the primary and secondary tumors which R0 resections are technically possible. (SCRLM: synchronous resection for both primary and secondary tumors, MCRLM: no local recurrence within 6 months after resection of primary tumor)
7. Residual hepatic volume\>30%-40%.
8. At least 2-3 hepatic segments remained after hepatectomy (except S1), residual liver with normal portal vein, hepatic artery and biliary duct, at least 1 of hepatic veins (left, middle and right) not invaded.
9. Tumor size ≤3 cm.
10. Tumor number≤ 3.
11. Tumors located ≥1.0 cm of vulnerable structures, e.g. colon, main trunk of portal vein, hepatic artery, hepatic vein and intrahepatic biliary duct.
12. suitable for both hepatectomy and local ablation after multiple disciplinary team(MDT) discussion.
13. Informed written consent.

Exclusion Criteria:

1. Other malignant tumors history.
2. Complications need emergency surgery (occlusion, sub-occlusion, massive hemorrhage and abscesses, et al.).
3. Colorectal or hepatic tumor extension towards abdominal wall and/or adjacent organ making liver R0 resection impossible immediately.
4. Hepatic lesions diagnosed with ultrasound and MRI making complete ablation impossible immediately.
5. ≤ 2 hepatic segments remained after hepatectomy or residual hepatic volume﹤30%-40%
6. Non resectable lymph node metastasis.
7. American Society of Anesthesiologists(ASA) grading≥ IV and/or Eastern cooperative oncology group(ECOG) score≥ 2. (see appendix)
8. EHD is not recommended.
9. Physical or psychological dependence.
10. Pregnant or breast feeding women.
11. Not controlled preoperational infection.
12. Enrolled in other clinical trials within 4 weeks. Other clinical or laboratorial condition not recommended by investigators.

Where this trial is running

Guangzhou, Guangdong

• The 6th Affiliated Hospital of Sun Yat-Sen University — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Meijin Huang, MD,PHD — The 6th Affiliated Hospital of Sun Yat-sen University
• Study coordinator: Meijin Huang, MD,PHD

Conditions Secondary Malignant Neoplasm of Liver; synchronous; metachronous; colorectal liver metastasis; resection; ablation