Back to resultsTACE Combined With Penpulimab and Anlotinib for Advanced HCC
Primary Purpose
Hepatocellular Carcinoma
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
TACE+penpulimab+anlotinib vs. penpulimab+anlotinib
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Hepatocellular carcinoma, Transarterial chemoembolization, Penpulimab, Anlotinib
Eligibility Criteria
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.
Sites / Locations
- Zhongda Hospital Affiliated to Southeast UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cohort I（TACE-A-A Cohort）
Cohort II (A-A Cohort)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Progression free survival (PFS)
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.
Secondary Outcome Measures
Objective response rate(ORR)
The proportion of patients with complete response (CR) and partial response (PR) according to the mRECIST criteria.
Overall survival (OS)
The time from initiation of either regimen of combination therapy to all-cause death.
Adverse effects
Adverse event (AE)，treatment emergent adverse event(TEAE)，serious adverse event (SAE)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05344924
Brief Title
TACE Combined With Penpulimab and Anlotinib for Advanced HCC
Official Title
Transarterial Chemoembolization Combined With Penpulimab and Anlotinib for Advanced Hepatocellular Carcinoma：A Nationwide Multicenter Prospective Real-world Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 12, 2022 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhongda Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Hepatocellular carcinoma, Transarterial chemoembolization, Penpulimab, Anlotinib
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
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).
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
109 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cohort I（TACE-A-A Cohort）
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort II (A-A Cohort)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
TACE+penpulimab+anlotinib vs. penpulimab+anlotinib
Other Intervention Name(s)
The combination of penpulimab+anlotinib with or without TACE
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression free survival (PFS)
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Objective response rate(ORR)
Description
The proportion of patients with complete response (CR) and partial response (PR) according to the mRECIST criteria.
Time Frame
2 years
Title
Overall survival (OS)
Description
The time from initiation of either regimen of combination therapy to all-cause death.
Time Frame
up to 5 years
Title
Adverse effects
Description
Adverse event (AE)，treatment emergent adverse event(TEAE)，serious adverse event (SAE)
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hai-Dong Zhu, MD
Phone
86-25-83262224
Email
zhuhaidong9509@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ri Li, MS
Phone
86-25-83262224
Email
qmjk_xsj@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gao-Jun Teng, MD
Organizational Affiliation
Zhongda Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongda Hospital Affiliated to Southeast University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hai Dong Zhu, MD
Phone
86-25-83262224
Email
zhuhaidong9509@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
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TACE Combined With Penpulimab and Anlotinib for Advanced HCC
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