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

NCT04814030 | Unknown Phase 2

• 1 other identifier: B2021-060
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• overall response rate

  defined as the sum of complete responses (CRs) and partial responses (PRs) over a specified time period

  12 month

Study Arms (1)

AIPD-1

EXPERIMENTAL

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

Drug: PD-1 inhibitor

Interventions

PD-1 inhibitor DRUG

Transarterial hepatic chemoembolization and FOLFOX-based infusion

Also known as: TACE-HAIC

AIPD-1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BCLC C stage with unresectable diseasehigh-recurrence risk factor;
• Child-Pugh A or B (7 score) liver function;
• Anticipated survival more than 3 moths

You may not qualify if:

• Pregnant woman or sucking period;
• With other malignant cancer;
• Received anti-HCC therapy before this study

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Immune Checkpoint Inhibitors

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Central Study Contacts

Jiliang Qiu

CONTACT

862087343114; qiujl@sysucc.org.cn

Xuzhi Pan

CONTACT

862087343009; kyk@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Trans hepatic arterial infusion of PD-1 antibody, chemoembolization and FOLFOX-based chemotherapy

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: March 24, 2021
• Study Start: April 20, 2021
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: April 23, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)