Combining Anlotinib and Penpulimab for Hepatocellular Carcinoma Treatment

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 clinical trial evaluates the effectiveness of anlotinib hydrochloride capsules combined with penpulimab injection in patients with hepatocellular carcinoma (HCC) who are at high risk of recurrence after undergoing radical surgery or ablation. Participants will be randomly assigned to receive either the combination treatment or a placebo, and the primary outcome will be the assessment of recurrence-free survival (RFS). The study aims to determine if this combination therapy can improve outcomes compared to standard care.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age: 18-75 years old; Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 1; Predicted survival ≥12 weeks.
* Subjects with hepatocellular carcinoma (HCC) confirmed by histopathology or cytology or who meet the diagnostic criteria for Primary Liver Cancer 2022 or the American Association for the Study of Hepatology (AASLD) hepatocellular carcinoma.
* Subjects who received radical excision or ablation (Radio Frequency Ablation (RFA) or Microwave Ablation (MWA) only) within 4 to 12 weeks prior to randomization (multiple modalities or combined or multiple treatments are not acceptable).
* No major vena portae 3 (Vp3) or vena portae 4 (Vp4) in the portal vein or any level of vascular invasion in the hepatic vein or inferior vena cava.
* No extrahepatic metastasis.
* High risk factors for recurrence after radical resection or complete ablation.
* Complete recovery from surgical resection or ablation within 4 weeks before randomization.

Exclusion Criteria:

* Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology.
* Evidence of residual, recurrent, or metastatic disease at randomization.
* More than one surgical treatment for hepatocellular carcinoma; Received more than 1 prophylactic Transcatheter Arterial Chemoembolization (TACE) treatment after surgery; or received Hepatic Artery Infusion Chemotherapy (HAIC) therapy after surgery.
* Previous use of antiangiogenic drugs or PD-1, Programmed Cell Death-Ligand 1 (PD-L1) and other related immunotherapy drugs or systemic chemotherapy drugs.

Where it's running

• The First Affiliated Hospital of Bengbu Medical College
  Bengbu, Anhui, China Recruiting
• Anhui Provincial Hospital
  Hefei, Anhui, China Recruiting
• Peking Union Medical College Hospital
  Beijing, Beijing Municipality, China Recruiting
• Cancer Hospital Chinese Academy of Medical Sciences
  Beijing, Beijing Municipality, China Recruiting
• Peking University People's Hospital
  Beijing, Beijing Municipality, China Recruiting
• Beijing Friendship hospital of Capital Medical University
  Beijing, Beijing Municipality, China Recruiting

+17 more sites. See ClinicalTrials.gov for the full list.

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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.