TACE Combined With Penpulimab and Anlotinib for Advanced HCC

December 28, 2022 updated by: Gao-jun Teng, Zhongda Hospital

Transarterial Chemoembolization Combined With Penpulimab and Anlotinib for Advanced Hepatocellular Carcinoma：A Nationwide Multicenter Prospective Real-world Study

The purpose of this multicenter, dual-cohort, prospective real-world study is to explore the efficacy and safety of penpulimab and anlotinib combined with or without TACE, as well as the optimum interval of the combination of penpulimab and anlotinib with TACE in advanced HCC patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The efficacy and safety of transarterial chemoembolization (TACE) combined with penpulimab and anlotinib in the treatment of advanced hepatocellular carcinoma (HCC) remain unknown. This is a multicenter, dual-cohort, prospective real-world study with patients receiving normal clinical care. Patients in cohort I will receive TACE combined with penpulimab and anlotinib (TACE-A-A Cohort), and patients in cohort II will just receive penpulimab and anlotinib (A-A Cohort). The primary endpoints of this study are the efficacy of penpulimab and anlotinib combined with or without TACE in advanced HCC patients. While the secondary endpoints include the safety of penpulimab and anlotinib combined with or without TACE, as well as the optimum interval of the combination of penpulimab and anlotinib with TACE in advanced HCC patients. The results will provide further evidence for the clinical practice and the design of future trials.

Study Type

Interventional

Enrollment (Anticipated)

109

Phase

  • Phase 2
  • 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 Contact

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Recruiting
        • Zhongda Hospital Affiliated to Southeast University
        • Contact:

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Pathologically or clinically diagnosed HCC patients;
  • Age of 18-80;
  • Barcelona Clinic Liver Cancer (BCLC) stage C (ie, China Liver Cancer Staging (CNLC) stage III);
  • with expect survival ≥ 3 months;
  • with obtained informed consent;
  • will receive penpulimab and anlotinib combined with or without TACE.

Exclusion criteria:

  • Contraindications of penpulimab and anlotinib;
  • Child-Pugh C;
  • Key information (such as imaging, liver function, Eastern Cooperative Oncology Group(ECOG) score, etc.) missing.

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort I（TACE-A-A Cohort）
Patients will receive TACE as needed; penpulimab 200 mg i.v. every 3 weeks(Q3W); and anlotinib 12 mg orally before breakfast,everyday(QD); continue taking for 2 weeks and stop for 1 week, that is, 3 weeks (21 days) as a course of treatment.
Drug: TACE+penpulimab+anlotinib vs. penpulimab+anlotinib
Patients will receive TACE as needed; penpulimab 200 mg i.v. every 3 weeks(Q3W); and anlotinib 12 mg orally before breakfast,everyday(QD); continue taking for 2 weeks and stop for 1 week, that is, 3 weeks (21 days) as a course of treatment.
Other Names:
  • The combination of penpulimab+anlotinib with or without TACE
Experimental: Cohort II (A-A Cohort)
Patients will receive penpulimab 200 mg i.v. every 3 weeks(Q3W); and anlotinib 12 mg orally before breakfast,everyday(QD); continue taking for 2 weeks and stop for 1 week, that is, 3 weeks (21 days) as a course of treatment.
Drug: TACE+penpulimab+anlotinib vs. penpulimab+anlotinib
Patients will receive TACE as needed; penpulimab 200 mg i.v. every 3 weeks(Q3W); and anlotinib 12 mg orally before breakfast,everyday(QD); continue taking for 2 weeks and stop for 1 week, that is, 3 weeks (21 days) as a course of treatment.
Other Names:
  • The combination of penpulimab+anlotinib with or without TACE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival (PFS)
Time Frame: 2 years
Time from initiation of either combination therapy to tumor progression according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria or death from any cause.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate(ORR)
Time Frame: 2 years
The proportion of patients with complete response (CR) and partial response (PR) according to the mRECIST criteria.
2 years
Overall survival (OS)
Time Frame: up to 5 years
The time from initiation of either regimen of combination therapy to all-cause death.
up to 5 years
Adverse effects
Time Frame: 2 years
Adverse event (AE)，treatment emergent adverse event(TEAE)，serious adverse event (SAE)
2 years

Collaborators and Investigators

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

Sponsor

Zhongda Hospital

Investigators

  • Principal Investigator: Gao-Jun Teng, MD, Zhongda hospital

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)

October 12, 2022

Primary Completion (Anticipated)

March 31, 2023

Study Completion (Anticipated)

March 31, 2024

Study Registration Dates

First Submitted

April 18, 2022

First Submitted That Met QC Criteria

April 18, 2022

First Posted (Actual)

April 25, 2022

Study Record Updates

Last Update Posted (Estimate)

December 29, 2022

Last Update Submitted That Met QC Criteria

December 28, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHANCE 2205

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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