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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Hepatocellular Carcinoma

In brief

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).

Key facts

Study ID

NCT05862337

Run by

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

People needed

480

Starts

2023-05-10

Expected to finish

2026-12-01

Last updated by the study team

2023-05-17

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• Chifeng Municipal Hospital — Chifeng, Inner Mongolia, China (enrolling)
• Jiangsu Province People's Hospital — Nanjing, Jiangsu, China (enrolling)
• Affiliated Cancer Hospital of Harbin Medical University — Harbin, Heilongjiang, China (enrolling)
• The Third Xiang Ya Hospital of Central South University — Changsha, Hunan, China (enrolling)
• Peking University People's Hospital — Beijing, Beijing Municipality, China (enrolling)
• The First People's Hospital of Changzhou — Changzhou, Jiangsu, China (enrolling)
• Anhui Provincial Hospital — Hefei, Anhui, China (enrolling)
• Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (enrolling)
• The First Affiliated Hospital of Henan University of Science and Technology — Luoyang, Henan, China (enrolling)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (enrolling)
• Fujian Cancer Hospital — Fuzhou, Fujian, China (enrolling)
• Gansu Provincial Cancer Hospital — Lanzhou, Gansu, China (enrolling)
• Beijing Friendship hospital of Capital Medical University — Beijing, Beijing Municipality, China (enrolling)
• The First Affiliated Hospital of Bengbu Medical College — Bengbu, Anhui, China (enrolling)
• Gansu Provincial Hospital — Lanzhou, Gansu, China (enrolling)
• Beijing YouAn Hospital,Capital Medical University — Beijing, Beijing Municipality, China (enrolling)
• Zhujiang Hospital of Southern Medical University — Guangzhou, Guangdong, China (enrolling)
• The Third Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (enrolling)
• Cancer Hospital Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (enrolling)
• Guizhou Provincial People'S Hospital — Guiyang, Guizhou, China (enrolling)
• Mengchao Hepatobiliary Hospital of Fujian Medical — Fuzhou, Fujian, China (enrolling)
• Affiliated Hospital Of Zunyi Medical University — Zunyi, Guizhou, China (enrolling)
• Hainan Provincial People's Hospital — Haikou, Hainan, China (enrolling)
• The Second Affiliated Hospital of Hainan Medical University — Haikou, Hainan, China (enrolling)
• Affiliated Hospital of Nantong University — Nantong, Jiangsu, China (enrolling)

Full record on ClinicalTrials.gov

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