Neoadjuvant liver‑artery chemotherapy plus PD‑1 immunotherapy, then PD‑1 after surgery, for high‑risk recurrent 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 is a phase 2, single‑center interventional trial enrolling patients with newly diagnosed, resectable hepatocellular carcinoma beyond Milan criteria (e.g., single tumor >5 cm or 2–3 tumors with the largest >3 cm) and preserved liver function. Participants receive neoadjuvant hepatic arterial infusion chemotherapy (HAIC) combined with PD‑1 immunotherapy, proceed to surgical resection if eligible, and then receive adjuvant PD‑1 therapy after surgery. Key eligibility requires no vascular invasion or distant/lymph node metastasis, Child‑Pugh A liver function, KPS ≥90, and adequate residual liver volume (>40%). The main goal is to increase surgical curability and reduce early postoperative recurrence rates compared with historical outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Newly diagnosed and untreated hepatocellular carcinoma (clinical diagnostic criteria based on the " Chinese Guidelines for the Diagnosis and Treatment of Hepatocellular Carcinoma (2024 Edition) " formulated by the National Health Commission of China and the Barcelona Clinic Liver Cancer (BCLC) strategy for prognosis prediction and treatment recommendation of the European Association for the Study of the Liver (EASL));
2. Tumor staging: beyond Milan criteria (single tumor \>5 cm, or 2-3 tumors with the largest diameter \>3 cm), resectable CNLC stage Ib/IIa hepatocellular carcinoma;
3. No tumor thrombus, distant metastasis, or lymph node metastasis;
4. Normal liver volume ≥ 700 cc, estimated residual liver volume \>40% after resection;
5. Patient KPS ≥ 90;
6. Liver function Child-Pugh class A;
7. Estimated survival of more than 6 months;
8. Function of important organs meets the following requirements: white blood cells ≥ 4.0×10\^9/l, neutrophils ≥ 1.5×10\^9/l, platelets ≥ 80.0×10\^9/l, hemoglobin ≥ 90 g/l; serum albumin ≥ 2.8 g/dl; total bilirubin ≤ 1.5 × ULN, ALT/AST/ALP ≤ 2.5 × ULN; serum creatinine ≤ 1.5 × ULN or creatinine clearance rate \> 60 mL/min; no severe organic diseases;
9. The subject must be able to understand and voluntarily sign a written informed consent form, and must sign the informed consent form prior to any specific procedure of the study, agreeing to comply with the medication and postoperative follow-up requirements as designed in this study.

Exclusion Criteria:

1. Combined with severe impairment of functions of other important organs such as heart, lungs, and kidneys; active infections other than viral hepatitis or other serious comorbid conditions, making the patient unable to tolerate treatment;
2. Contraindications to surgical resection and immunotherapy;
3. History of other malignant tumors;
4. Combined with immunological diseases or other conditions requiring long-term steroid treatment;
5. Known or suspected allergy to the study drug or any drugs administered in connection with this trial;
6. History of organ transplantation;
7. Pregnant or breastfeeding women;
8. Other factors that may affect patient enrollment and assessment outcomes;
9. Refusal to follow-up according to the requirements set by the study protocol, and refusal to sign the informed consent form.

Where it's running

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

Study contacts

• Principal investigator: Yaojun Zhang, MD, PHD — Sun Yat-Sen University Cancer Center
• Study coordinator: Yaojun Zhang, MD, PHD
• Email: zhangyuj@sysucc.org.cn
• Phone: +8613719433968

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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.