Anatomic vs nonanatomic liver resection after conversion therapy for liver cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective observational cohort will compare two surgical approaches for patients with initially unresectable hepatocellular carcinoma who become eligible for resection after immune checkpoint inhibitor–based conversion therapy. Participants are assigned to ALR or NALR based on the procedure they receive, and the primary outcome is 2-year recurrence-free survival. Regular imaging and follow-up will monitor survival and disease status. Enrollment aims for about 874 participants, with roughly equal numbers in each arm, to inform surgical decision-making in this setting.

Why it matters

Who can join: the full rules

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.

Where it's running

• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Chenwei Wang
• Email: wangchw@sysucc.org.cn
• Phone: 020-87343114

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.