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

May 15, 2023 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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).

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

480

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Anhui
      • Bengbu, Anhui, China, 233000
        • Recruiting
        • The First Affiliated Hospital Of Bengbu Medical College
        • Contact:
      • Hefei, Anhui, China, 230000
        • Recruiting
        • Anhui Provincial Hospital
        • Contact:
      • Hefei, Anhui, China, 230000
        • Not yet recruiting
        • The First Affiliated Hospital of Anhui Medical University
        • Contact:
          • Yufeng Gao, Doctor
          • Phone Number: +86 13956938032
          • Email: aygyf@126.com
    • Beijing
      • Beijing, Beijing, China, 100005
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
      • Beijing, Beijing, China, 100044
        • Recruiting
        • Peking University People's Hospital
        • Contact:
      • Beijing, Beijing, China, 100069
        • Recruiting
        • Beijing Youan Hospital,Capital Medical University
        • Contact:
          • Yonghong Zhang, Doctor
          • Phone Number: +86 13810108505
      • Beijing, Beijing, China, 100020
        • Recruiting
        • Cancer Hospital Chinese Academy of Medical Sciences
        • Contact:
      • Beijing, Beijing, China, 100050
        • Recruiting
        • Beijing Friendship Hospital of Capital Medical University
        • Contact:
    • Chongqing
      • Chongqing, Chongqing, China, 400030
        • Not yet recruiting
        • Chongqing University Cancer Hospital
        • Contact:
      • Chongqing, Chongqing, China, 404199
        • Not yet recruiting
        • Chongqing University Three Gorges Hospital
        • Contact:
    • Fujian
      • Fuzhou, Fujian, China, 350011
        • Recruiting
        • Fujian Cancer Hospital
        • Contact:
      • Fuzhou, Fujian, China, 350001
        • Recruiting
        • Mengchao Hepatobiliary Hospital of Fujian Medical
        • Contact:
    • Gansu
      • Lanzhou, Gansu, China, 730030
        • Not yet recruiting
        • Lanzhou University Second Hospital
        • Contact:
      • Lanzhou, Gansu, China, 730700
        • Recruiting
        • Gansu Provincial Hospital
        • Contact:
      • Lanzhou, Gansu, China, 730000
        • Recruiting
        • Gansu Provincial Cancer Hospital
        • Contact:
      • Lanzhou, Gansu, China, 730000
        • Not yet recruiting
        • Lanzhou University First Hospital
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510280
        • Recruiting
        • Zhujiang Hospital of Southern Medical University
        • Contact:
      • Guangzhou, Guangdong, China, 510630
        • Recruiting
        • The Third Affiliated Hospital of Sun Yat-sen University
        • Contact:
      • Guangzhou, Guangdong, China, 510000
        • Not yet recruiting
        • Guangdong People's Hospital
        • Contact:
    • Guangxi
      • Nanning, Guangxi, China, 530000
        • Not yet recruiting
        • Guangxi Medical University Affiliated Tumor Hospital
        • Contact:
    • Guizhou
      • Guiyang, Guizhou, China, 550002
        • Recruiting
        • Guizhou Provincial People's Hospital
        • Contact:
      • Guiyang, Guizhou, China, 550008
        • Not yet recruiting
        • The Affiliated Cancer Hospital of Guizhou Medical University
        • Contact:
      • Zunyi, Guizhou, China, 563000
        • Recruiting
        • Affiliated Hospital of Zunyi Medical University
        • Contact:
    • Hainan
      • Haikou, Hainan, China, 570311
        • Recruiting
        • Hainan Provincial People's Hospital
        • Contact:
      • Haikou, Hainan, China, 570311
        • Recruiting
        • The Second Affiliated Hospital of Hainan Medical University
        • Contact:
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Recruiting
        • Affiliated Cancer Hospital of Harbin Medical University
        • Contact:
    • Henan
      • Luoyang, Henan, China, 471000
        • Recruiting
        • The First Affiliated Hospital of Henan University of Science and Technology
        • Contact:
      • Zhengzhou, Henan, China, 450000
        • Recruiting
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:
      • Zhengzhou, Henan, China, 450003
        • Not yet recruiting
        • Henan Cancer Hospital
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410000
        • Not yet recruiting
        • Hunan Cancer Hospital
        • Contact:
      • Changsha, Hunan, China, 410000
        • Not yet recruiting
        • Hunan Provincial People's Hospital
        • Contact:
      • Changsha, Hunan, China, 410000
        • Recruiting
        • The Third Xiang Ya Hospital of Central South University
        • Contact:
      • Changsha, Hunan, China, 410000
        • Not yet recruiting
        • Xiangya Hospital of Central South University
        • Contact:
          • Ledu Zhou, Doctor
          • Phone Number: +86 17373120367
          • Email: csuzld@126.com
    • Inner Mongolia
      • Chifeng, Inner Mongolia, China, 240000
        • Recruiting
        • Chifeng Municipal Hospital
        • Contact:
    • Jiangsu
      • Changzhou, Jiangsu, China, 213000
        • Recruiting
        • The First People's Hospital of Changzhou
        • Contact:
      • Nanjing, Jiangsu, China, 210000
        • Recruiting
        • Jiangsu Province People's Hospital
        • Contact:
          • Xiangcheng Li, Doctor
          • Phone Number: +86 18951999088
          • Email: drlixc@163.com
      • Nantong, Jiangsu, China, 226361
        • Not yet recruiting
        • Nantong Tumor Hospital
        • Contact:
          • Bingfeng Shao, Bachelor
          • Phone Number: +86 13962981592
          • Email: ntzlsbf@163.com
      • Nantong, Jiangsu, China, 226006
        • Recruiting
        • Affiliated Hospital of Nantong University
        • Contact:
    • Jiangxi
      • Ganzhou, Jiangxi, China, 341099
        • Recruiting
        • Ganzhou People's Hospital
        • Contact:
          • Song Zou, Bachelor
          • Phone Number: +86 13879757375
          • Email: 1758771@qq.com
      • Nanchang, Jiangxi, China, 330000
        • Recruiting
        • The Second Affiliated Hospital of Nanchang University
        • Contact:
          • Linquan Wu, Doctor
          • Phone Number: +86 13607912265
          • Email: wulqnc@163.com
    • Jilin
      • Changchun, Jilin, China, 130012
        • Not yet recruiting
        • Jilin Cancer Hospital
        • Contact:
    • Liaoning
      • Dalian, Liaoning, China, 116027
        • Recruiting
        • The Second Hospital of Dalian Medical University
        • Contact:
      • Jinzhou, Liaoning, China, 121012
        • Recruiting
        • The First Affiliated Hospital of Jinzhou Medical University
        • Contact:
          • Hongzhi Sun, Doctor
          • Phone Number: +86 13840650008
          • Email: cmushz@163.com
      • Shenyang, Liaoning, China, 110000
        • Not yet recruiting
        • Shengjing Hospital of China Medical University
        • Contact:
      • Shenyang, Liaoning, China, 110801
        • Not yet recruiting
        • Liaoning cancer hospital
        • Contact:
          • Xiangdong Hua, Doctor
          • Phone Number: +86 13940126803
          • Email: LnzlHxd@163.com
      • Shenyang, Liaoning, China, 110000
        • Recruiting
        • The Sixth People's Hospital of Shen Yang
        • Contact:
    • Shandong
      • BinZhou, Shandong, China, 256699
        • Recruiting
        • Binzhou Medical University Hospital
        • Contact:
      • Jinan, Shandong, China, 250117
        • Not yet recruiting
        • Shandong Cancer Hospital
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200433
        • Recruiting
        • The First Affiliated Hospital of Naval Medical University
        • Contact:
      • Shanghai, Shanghai, China, 200433
        • Recruiting
        • Third Affiliated Hospital of Naval Medical University
        • Contact:
    • Shanxi
      • Baoji, Shanxi, China, 721000
        • Recruiting
        • Baoji Central Hospital
        • Contact:
      • Changzhi, Shanxi, China, 46000
        • Recruiting
        • Heping Hospital Affiliated to Changzhi Medical College
        • Contact:
          • Buqiang Wu, Doctor
          • Phone Number: +86 13934055258
          • Email: wuli67@163.com
      • Xi'an, Shanxi, China, 710038
        • Not yet recruiting
        • The Second Affiliated Hospital of Air Force Medical University
        • Contact:
      • Xi'an, Shanxi, China, 710061
        • Not yet recruiting
        • First Affiliated Hospital of Xian Jiaotong University
        • Contact:
      • Xi'an, Shanxi, China, 710117
        • Recruiting
        • Xi'an International Medical Center Hospital
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • Recruiting
        • West China Hospital of Sichuan University
        • Contact:
      • Luzhou, Sichuan, China, 646000
        • Recruiting
        • Affiliated Hospital of Southwest Medical University
        • Contact:
      • Nanchong, Sichuan, China, 637000
        • Recruiting
        • Affiliated Hospital of North Sichuan Medical College
        • Contact:
    • Tianjin
      • Tianjin, Tianjin, China, 300000
        • Recruiting
        • Tianjin Third Central Hospital
        • Contact:
      • Tianjin, Tianjin, China, 300308
        • Recruiting
        • Tianjin Cancer Hospital Airport Hospital
        • Contact:
      • Tianjin, Tianjin, China, 300181
        • Recruiting
        • Tianjin Medical University Cancer Institute & Hospital
        • Contact:
    • Xinjiang
      • Ürümqi, Xinjiang, China, 830000
        • Not yet recruiting
        • The First Affiliated Hospital of Xinjiang Medical University
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • Sir Run Run Shaw Hospital Zhetiang University School of Medicine
        • Contact:
      • Ningbo, Zhejiang, China, 315000
        • Recruiting
        • Ningbo Medical Center Lihuili Hospital
        • Contact:
      • Shaoxing, Zhejiang, China, 312000
        • Recruiting
        • Shaoxing People's Hospital
        • Contact:
      • Taizhou, Zhejiang, China, 317000
        • Recruiting
        • Taizhou Hospital of Zhejiang Province
        • Contact:
      • Wenzhou, Zhejiang, China, 325000
        • Recruiting
        • The First Affiliated Hospital of Wenzhou Medical University
        • Contact:
          • Chang Yu, Doctor
          • Phone Number: +86 13906650823
          • Email: wzmcyc@126.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Anlotinib hydrochloride capsules + Penpulimab injection
Anlotinib hydrochloride capsules + Penpulimab injection, 21 days as a treatment cycle.
Drug: Anlotinib hydrochloride capsules, Penpulimab injection

Anlotinib hydrochloride capsules is a multitargeted receptor tyrosine kinase inhibitor.

Penpulimab injection is a humanized monoclonal antibody targeting programmed cell death protein 1 (PD-1).
Placebo Comparator: Anlotinib hydrochloride capsules -matching placebo+ Penpulimab injection -matching placebo
Anlotinib hydrochloride capsules -matching placebo+ penpulimab injection -matching placebo, 21 days as a treatment cycle.
Drug: Anlotinib hydrochloride capsules -matching placebo, Penpulimab injection -matching placebo
placebo control, no active substance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence-free survival (RFS)
Time Frame: Baseline up to 3 years.
RFS assessed by the Blinded Independent Image Review Committee and the investigator is the time from randomization to the first local, regional recurrence or distant metastasis, or death from any cause, whichever occurred first.
Baseline up to 3 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to recurrence(TTR)
Time Frame: Baseline up to 3 years.
TTR assessed by the Blinded Independent Image Review Committee and the investigator is the time from randomization to the first local, regional recurrence or distant metastasis, whichever occurred first.
Baseline up to 3 years.
Time to extrahepatic metastasis or macrovascular invasion
Time Frame: Baseline up to 3 years.
Time to extrahepatic metastasis or macrovascular invasion as assessed by the investigator.
Baseline up to 3 years.
Overall survival (OS)
Time Frame: Baseline up to 3 years.
OS defined as the time from the date of randomization until the date of death due to any cause.
Baseline up to 3 years.
Objective response rate (ORR) after first recurrence
Time Frame: Baseline up to 3 years.
subjects with evaluable tumor lesion status who were cross-treated with Anlotinib hydrochloride capsules combined with Penpulimab injection developed complete response or partial response after a first HCC relapse as assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.
Baseline up to 3 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2023

Primary Completion (Anticipated)

August 1, 2024

Study Completion (Anticipated)

December 1, 2026

Study Registration Dates

First Submitted

May 15, 2023

First Submitted That Met QC Criteria

May 15, 2023

First Posted (Actual)

May 17, 2023

Study Record Updates

Last Update Posted (Actual)

May 17, 2023

Last Update Submitted That Met QC Criteria

May 15, 2023

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALTN-AK105-III-06

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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