TACE Combined With Penpulimab and Anlotinib for Advanced HCC
NCT ID: NCT05344924
Last Updated: 2022-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
109 participants
INTERVENTIONAL
2022-10-12
2024-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Child-Pugh C;
* Key information (such as imaging, liver function, Eastern Cooperative Oncology Group(ECOG) score, etc.) missing.
18 Years
80 Years
ALL
No
Sponsors
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Zhongda Hospital
OTHER
Responsible Party
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Gao-jun Teng
Head of Zhongda Hospital
Principal Investigators
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Gao-Jun Teng, MD
Role: PRINCIPAL_INVESTIGATOR
Zhongda Hospital
Locations
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Zhongda Hospital Affiliated to Southeast University
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Hai Dong Zhu, MD
Role: primary
Other Identifiers
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CHANCE 2205
Identifier Type: -
Identifier Source: org_study_id