Back to resultsTransarterial Infusion of PD-1 Antibody Plus TACE-HAIC for Unresectable HCC: a Single-arm, Phase 2 Clinical Trial (AIPD-1)
Primary Purpose
Hepatocellular Carcinoma
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
PD-1 inhibitor
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma
Eligibility Criteria
Inclusion Criteria:
- BCLC C stage with unresectable diseasehigh-recurrence risk factor;
- Child-Pugh A or B (7 score) liver function;
- Anticipated survival more than 3 moths
Exclusion Criteria:
- Pregnant woman or sucking period;
- With other malignant cancer;
- Received anti-HCC therapy before this study
Sites / Locations
- Sun Yat-sen University Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AIPD-1
Arm Description
Trans hepatic artery infusion of PD-1 antibody, chemoembolization, FOLFOX-based infusion chemotherapy
Outcomes
Primary Outcome Measures
overall response rate
defined as the sum of complete responses (CRs) and partial responses (PRs) over a specified time period
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04814030
Brief Title
Transarterial Infusion of PD-1 Antibody Plus TACE-HAIC for Unresectable HCC: a Single-arm, Phase 2 Clinical Trial
Acronym
AIPD-1
Official Title
Transarterial Infusion of PD-1 Antibody Plus Chemoembolization and FOLFOX-based Chemtherapy for Unresectable BCLC C Stage HCC: a Single-arm, Phase 2 Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 20, 2021 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Hepatocellular carcinoma (HCC) is a common disease in East Asia. Less than 20% of newly diagnosed patients can undergo radical resection. For those with unresectable BCLC C stage, transarterial chemotherapy and targeted therapy are recommend to prolong survival. Recently, FOLFOX (Oxaliplatin and 5-fluorouracil) based hepatic artery infusion chemotherapy (HAIC) exhibited high response rate for unresectable HCC. Transartery infusion of agents provide promising outcome when compared systemic infusion. Furthermore, our pilot study showed TACE combined HAIC (TACE-HAIC) had better tumor response, with low progression disease rate. Whether TACE-HAIC plus hepatic artery infusion PD-1 antibody would improve survival for unresectalbe BCLC C stage patients is still unknown. A single arm, phase 2 clinical trial is aimed to answer this question.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Trans hepatic arterial infusion of PD-1 antibody, chemoembolization and FOLFOX-based chemotherapy
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AIPD-1
Arm Type
Experimental
Arm Description
Trans hepatic artery infusion of PD-1 antibody, chemoembolization, FOLFOX-based infusion chemotherapy
Intervention Type
Drug
Intervention Name(s)
PD-1 inhibitor
Other Intervention Name(s)
TACE-HAIC
Intervention Description
Transarterial hepatic chemoembolization and FOLFOX-based infusion
Primary Outcome Measure Information:
Title
overall response rate
Description
defined as the sum of complete responses (CRs) and partial responses (PRs) over a specified time period
Time Frame
12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
BCLC C stage with unresectable diseasehigh-recurrence risk factor;
Child-Pugh A or B (7 score) liver function;
Anticipated survival more than 3 moths
Exclusion Criteria:
Pregnant woman or sucking period;
With other malignant cancer;
Received anti-HCC therapy before this study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiliang Qiu
Phone
862087343114
Email
qiujl@sysucc.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Xuzhi Pan
Phone
862087343009
Email
kyk@sysucc.org.cn
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yunfei Yuan
Phone
862087343118
Email
yuanyf@sysucc.org.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Transarterial Infusion of PD-1 Antibody Plus TACE-HAIC for Unresectable HCC: a Single-arm, Phase 2 Clinical Trial
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