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Surgery Plus Systemic Therapy for Liver Cancer With Extrahepatic Metastases

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Summary

NIH ClinicalTrials.gov has registered NCT07537959, a randomized trial evaluating whether adding primary tumor resection to standard immune-based systemic therapy improves survival in hepatocellular carcinoma patients with extrahepatic metastases. The study will enroll approximately 252 participants and measure overall survival as the primary endpoint.

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What changed

NIH ClinicalTrials.gov has registered a new clinical trial (NCT07537959) evaluating surgery plus systemic therapy versus systemic therapy alone for hepatocellular carcinoma patients with extrahepatic metastases. The randomized trial will assess primary tumor resection combined with protocol-allowed first-line immune-based systemic therapy, with overall survival as the primary outcome measure.

This trial registration applies to clinical investigators and trial sponsors conducting interventional studies. Parties conducting applicable clinical trials must ensure registration on ClinicalTrials.gov per FDAAA 801 requirements and maintain compliance with NIH formatting and update requirements.

Archived snapshot

Apr 18, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

← ClinicalTrials.gov Studies

Surgery Plus Systemic Therapy for Liver Cancer With Extrahepatic Metastases

N/A NCT07537959 Kind: NA Apr 17, 2026

Abstract

This study will evaluate whether resection of the primary liver tumor, in addition to standard first-line systemic therapy, improves survival in patients with hepatocellular carcinoma that has spread outside the liver but still has a resectable primary intrahepatic tumor. Participants will be randomly assigned to receive either primary tumor resection followed by protocol-allowed first-line immune-based systemic therapy or systemic therapy alone. The primary outcome is overall survival. Secondary outcomes include progression-free survival, objective response rate, disease control rate, immune-related adverse events, postoperative complications, and quality of life.

Conditions: Hepatocellular Carcinoma (HCC), Metastasis

Interventions: Primary Tumor Resection, Protocol-Allowed First-Line Immune-Based Systemic Therapy

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Classification

Agency
NIH
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor

Who this affects

Applies to
Clinical investigators Trial sponsors Healthcare providers
Industry sector
5417 Scientific Research
Activity scope
Clinical trial conduct Patient enrollment
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Compliance frameworks
GxP
Topics
Public Health Pharmaceuticals

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