Anatomic Versus Nonanatomic Liver Resection After Conversion Therapy for Hepatocellular Carcinoma

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type

Observational

Phase

Not applicable / not listed

Age range

18 years - 75 years

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

874 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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 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)

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not reported

Masking

Not reported

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

Sun Yat-sen University

Study start

Oct 25, 2026 Estimated

Primary completion

Dec 31, 2030 Estimated

Study completion

Dec 31, 2030 Estimated

First posted

Nov 10, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts