Anlotinib Hydrochloride Capsules Combined With Penpulimab Injection for the Treatment of Hepatocellular Carcinoma at High Risk of Recurrence.

The primary objective of this study was to evaluate the efficacy of anlotinib hydrochloride capsules combined with penpulimab injection (test group) versus placebo (control group) for adjuvant therapy after radical surgery or ablation in HCC patients with high risk of recurrence by assessing recurrence-free survival (RFS).

Trial Details

NCT ID
NCT05862337
Phase
PHASE3
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Status
RECRUITING
Cancer Type
Liver Cancer
Interventions
  • Anlotinib hydrochloride capsules, Penpulimab injection
  • Anlotinib hydrochloride capsules -matching placebo, Penpulimab injection -matching placebo
Locations (sample)
  • Bengbu, Anhui, China|32.94083,117.36083
  • Beijing, Beijing Municipality, China|39.9075,116.39723
  • Beijing, Beijing Municipality, China|39.9075,116.39723
  • Chongqing, Chongqing Municipality, China|29.56026,106.55771
  • Fuzhou, Fujian, China|26.06139,119.30611

Key Eligibility 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 2…
  • Subjects who received radical excision or ablation (Radio Frequency Ablation (RFA) or Microwave Ablation (MWA) only) within 4 to 12 weeks prior to …
  • 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.

For full eligibility, visit ClinicalTrials.gov.

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