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Combining Anlotinib and Penpulimab for Hepatocellular Carcinoma Treatment

A Randomized, Double-blind, Placebo-controlled, Multicenter Phase 3 Study of Anlotinib Hydrochloride Capsules Combined With Penpulimab Injection in Patients With High Risk of Relapse After Radical Surgery or Ablation of Hepatocellular Carcinoma (HCC).

Phase 3 Interventional Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · NCT05862337

This study is testing if a new combination of two treatments can help prevent liver cancer from coming back in patients who are at high risk after surgery or other treatments.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment480 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd. Industry-sponsored
Drugs / interventionsChemotherapy, immunotherapy, penpulimab, anlotinib
Locations67 sites (Bengbu, Anhui and 66 other locations)
Trial IDNCT05862337 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with confirmed hepatocellular carcinoma who have undergone radical excision or ablation within the last 4 to 12 weeks.

Not a fit: Patients with extrahepatic metastasis or significant vascular invasion are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the risk of recurrence in patients with hepatocellular carcinoma after surgery.

How similar studies have performed: Other studies have shown promise in using combination therapies for cancer treatment, suggesting potential success for this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Bengbu, Anhui and 66 other locations

+17 more sites — see ClinicalTrials.gov for the full list.

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Hepatocellular Carcinoma
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.