- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04814030
Transarterial Infusion of PD-1 Antibody Plus TACE-HAIC for Unresectable HCC: a Single-arm, Phase 2 Clinical Trial (AIPD-1)
April 21, 2021 updated by: Yunfei Yuan, Sun Yat-sen University
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
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
80
Phase
- Phase 2
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
- Name: Xuzhi Pan
- Phone Number: 862087343009
- Email: kyk@sysucc.org.cn
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510060
- Recruiting
- Sun Yat-Sen University Cancer Center
-
Contact:
- Yunfei Yuan
- Phone Number: 862087343118
- Email: yuanyf@sysucc.org.cn
-
-
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 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: AIPD-1
Trans hepatic artery infusion of PD-1 antibody, chemoembolization, FOLFOX-based infusion chemotherapy
|
Transarterial hepatic chemoembolization and FOLFOX-based infusion
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
overall response rate
Time Frame: 12 month
|
defined as the sum of complete responses (CRs) and partial responses (PRs) over a specified time period
|
12 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
April 20, 2021
Primary Completion (ANTICIPATED)
December 30, 2022
Study Completion (ANTICIPATED)
December 30, 2022
Study Registration Dates
First Submitted
March 23, 2021
First Submitted That Met QC Criteria
March 23, 2021
First Posted (ACTUAL)
March 24, 2021
Study Record Updates
Last Update Posted (ACTUAL)
April 23, 2021
Last Update Submitted That Met QC Criteria
April 21, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Digestive System Neoplasms
- Liver Diseases
- Liver Neoplasms
- Carcinoma, Hepatocellular
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Immune Checkpoint Inhibitors
Other Study ID Numbers
- B2021-060
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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