Transarterial Infusion of PD-1 Antibody Plus TACE-HAIC for Unresectable HCC: a Single-arm, Phase 2 Clinical Trial

NCT ID: NCT04814030

Last Updated: 2021-04-23

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-20

Study Completion Date

2022-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Trans hepatic arterial infusion of PD-1 antibody, chemoembolization and FOLFOX-based chemotherapy
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AIPD-1

Trans hepatic artery infusion of PD-1 antibody, chemoembolization, FOLFOX-based infusion chemotherapy

Group Type EXPERIMENTAL

PD-1 inhibitor

Intervention Type DRUG

Transarterial hepatic chemoembolization and FOLFOX-based infusion

Interventions

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PD-1 inhibitor

Transarterial hepatic chemoembolization and FOLFOX-based infusion

Intervention Type DRUG

Other Intervention Names

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TACE-HAIC

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Yunfei Yuan

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jiliang Qiu

Role: CONTACT

862087343114

Xuzhi Pan

Role: CONTACT

862087343009

Facility Contacts

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Yunfei Yuan

Role: primary

862087343118

Other Identifiers

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B2021-060

Identifier Type: -

Identifier Source: org_study_id

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