Anatomic Versus Nonanatomic Liver Resection After Conversion Therapy for Hepatocellular Carcinoma

Anatomic Versus Non-anatomic Liver Resection After Successful Immune Checkpoint Inhibitor-Based Conversion Therapy for Initially Unresectable Hepatocellular Carcinoma: A Prospective Cohort Study

This prospective observational cohort study will compare the survival outcomes of anatomic liver resection (ALR) versus nonanatomic liver resection (NALR) in patients with initially unresectable hepatocellular carcinoma (HCC) who become eligible for resection following immune checkpoint inhibitor (ICI)-based conversion therapy. Emerging evidence suggests that surgical resection may provide a survival benefit for selected patients with initially unresectable HCC after conversion therapy; however, the optimal surgical approach for these patients remains unclear. This study aims to inform surgical decision-making in this setting. Participants will be included in one of two cohorts according to the procedure received: ALR or NALR. The primary outcome is the 2-year recurrence-free survival (RFS) rate. Participants will undergo regular imaging assessments and survival follow-up. The target enrollment is 874 participants, with approximately 437 planned for each cohort; because treatment allocation is not randomized, the actual cohort sizes may differ.

Study Overview

• Status: Recruiting
• Conditions: Hepato Cellular Carcinoma (HCC); Liver Resection; Conversion Therapy

• Study Type: Observational
• Enrollment (Estimated): 874

Contacts and Locations

• Study Contact: Name: Chenwei Wang; Phone Number: 020-87343114; Email: wangchw@sysucc.org.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • Sun Yat-sen University Cancer Center
      • Contact: Chenwei Wang; Phone Number: 020-87343114; Email: wangchw@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with initially unresectable HCC who underwent liver resection after successful immune checkpoint inhibitor-based conversion therapy conversion therapy at the Sun Yat-sen University Cancer Center (SYSUCC)

Description

Inclusion Criteria:

• Clinical diagnosis of initially unresectable HCC
• Received conversion therapy based on PD-1/PD-L1 therapy.
• Two liver surgeons with associate senior or higher professional titles determine that R0 resection is feasible after conversion therapy.
• Child-Pugh class A liver function.
• ECOG performance status 0 or 1.
• Adequate organ and bone marrow function, based on laboratory tests within 7 days before enrollment: ANC ≥1.5 × 10^9/L; platelet count ≥75 × 10^9/L; hemoglobin ≥9.0 g/dL; total bilirubin ≤1.5 × ULN; ALT, AST, and ALP ≤3 × ULN; serum albumin ≥28 g/L; serum creatinine ≤1.5 × ULN or creatinine clearance ≥50 mL/min by Cockcroft-Gault; urine protein <2+, or, if ≥2+ at baseline, 24-hour urine protein <1 g; INR and APTT ≤1.5 × ULN; TSH between the lower and upper limits of normal (if abnormal, FT3 and FT4 must be normal).

Exclusion Criteria:

• Any cancer treatment other than conversion therapy.
• Any of the following within 12 months before study start: myocardial infarction, severe/unstable angina, coronary artery bypass grafting, congestive heart failure, cerebrovascular accident (including transient ischemic attack), or pulmonary embolism; ongoing arrhythmia of CTCAE Grade 2 or higher; or QTc >450 ms in men or >470 ms in women.
• Renal insufficiency requiring peritoneal dialysis or hemodialysis.
• Severe dysfunction of another major organ.
• Prior diagnosis of a second primary malignancy.
• Known or new evidence of brain or leptomeningeal disease.
• Hemophilia or bleeding tendency, or therapeutic anticoagulation with coumarin derivatives.
• Prior organ transplantation.

Study Plan

How is the study designed?

Design Details

• Observational Models: COHORT
• Time Perspectives: PROSPECTIVE

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Anatomic Liver Resection (ALR); Participants with HCC who undergo anatomic liver resection after conversion therapy.
Non-anatomic Liver Resection (NALR); Participants with HCC who undergo nonanatomic liver resection after conversion therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
2-year recurrence-free survival (RFS) rate	From enrollment to the end of treatment at 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence-free survival (RFS)	Time from study entry to disease recurrence or death from any cause, whichever occurs first.	Time from study entry to disease recurrence or death from any cause, whichever occurs first, assessed up to 5 years.
Overall survival (OS)	Time from study entry to death from any cause	Time from study entry to death from any cause, assessed up to 5 years.
Time to recurrence (TTR)	Time from study entry to recurrence	Time from study entry to recurrence, assessed up to 5 years.

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Estimated): October 25, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: October 22, 2026
• First Submitted That Met QC Criteria: November 9, 2026
• First Posted (Actual): November 10, 2026

Study Record Updates

• Last Update Posted (Actual): November 10, 2026
• Last Update Submitted That Met QC Criteria: November 9, 2026
• Last Verified: October 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: B2026-494-01