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PD-1 Antibody and Lenvatinib Plus TACE-HAIC for Potential Resectable HCC: a Single-arm, Phase 2 Clinical Trial (PLATIC)

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ClinicalTrials.gov Identifier: NCT04814043
Recruitment Status : Recruiting
First Posted : March 24, 2021
Last Update Posted : September 22, 2021
Sponsor:
Information provided by (Responsible Party):
Yunfei Yuan, Sun Yat-sen University

Study Description
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Brief Summary:
Hepatocellular carcinoma (HCC) is one of the most commonly malignant tumors around the world. Hepatic resection or liver transplantation is the radical method to cure the disease. However, less than 20% of newly diagnosed patients can undergo radical resection. Our latest study showed that 48% potentially resectable HCC received hepatectomy after transarterial chemoembolization plus FOLFOX-based chemotherapy infusion (TACE-HAIC) treatment. Recently, several clinical trials (LEAP-002) showed that PD-1 antibody and Lenvatinib had an ORR of 36% for advanced patients. The combination of TACE-HAIC with PD-1 antibody and lenvatinib, theoretically can significantly decrease the tumor burden and increase the hepatectomy rate. However, this hasn't been verified in clinical application. To identify a more effective and safety way for treating potentially resectable HCC patients, this study is designed to investigate TACE-HAIC plus PD-1 antibody and Lenvatinib will increase the resection rate for those patients.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: PD-1 inhibitor Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 57 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: systemic PD-1 antibody and lenvatinib plus TACE-HAIC for potential resectable HCC
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Systemic PD-1 Antibody (Sintilimab) and Lenvatinib Plus Transarterial Chemoembolization and FOLFOX-based Chemotherapy Infusion for Potential Resectable HCC: a Single-arm, Phase 2 Clinical Trial
Actual Study Start Date : April 20, 2021
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : December 30, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: PD-1 antibody and lenvatinib plus TACE-HAIC
systemic PD-1 antibody (Sintilimab) and lenvatinib plus transarterial chemobolization and FOLFOX-based chemotherapy infusion
 Drug: PD-1 inhibitor
systemic PD-1 antibody (Sintilimab) and lenvatinib plus transarterial chemobolization and FOLFOX-based chemotherapy infusion
Other Names:
  • lenvatinib
  • TACE-HAIC


Outcome Measures
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Primary Outcome Measures :
  1. conversion rate to resection [ Time Frame: 12 month ]
    The conversion rate to resection among all the enrolled patients


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed as potentially resectable with consensus by the panel of liver surgeons
  • stage BCLC A/B/C, without extra-hepatic involvement
  • No previous anti-HCC treatment
  • Eastern Co-operative Group performance status 2 or less
  • Liver function: Child's A or B (score < 7)

Exclusion Criteria:

  • Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy

    • underlying serve cardiac or renal diseases Known or suspected allergy to the investigational agent or any agent given in association with this trial
    • Patients ineligible for hepatic artery embolization, or PD-1 antibody
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04814043


Contacts
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Contact: Jiliang Qiu +862087343114 qiujl@sysucc.org.cn

Locations
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China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Jiliang Qiu    +862087342651    qiujl@sysucc.org.cn   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Yunfei Yuan Sun Yat-sen University
More Information
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Responsible Party: Yunfei Yuan, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT04814043    
Other Study ID Numbers: B2020-411
First Posted: March 24, 2021    Key Record Dates
Last Update Posted: September 22, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Digestive System Diseases
Liver Diseases
Lenvatinib
Immune Checkpoint Inhibitors
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action