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

Primary Purpose

Hepatocellular Carcinoma

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
PD-1 inhibitor
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sun Yat-sen University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PD-1 antibody and lenvatinib plus TACE-HAIC

Arm Description

systemic PD-1 antibody (Sintilimab) and lenvatinib plus transarterial chemobolization and FOLFOX-based chemotherapy infusion

Outcomes

Primary Outcome Measures

conversion rate to resection
The conversion rate to resection among all the enrolled patients

Secondary Outcome Measures

Full Information

First Posted
March 23, 2021
Last Updated
September 20, 2021
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT04814043
Brief Title
PD-1 Antibody and Lenvatinib Plus TACE-HAIC for Potential Resectable HCC: a Single-arm, Phase 2 Clinical Trial
Acronym
PLATIC
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
April 20, 2021 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
December 30, 2023 (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 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.

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
systemic PD-1 antibody and lenvatinib plus TACE-HAIC for potential resectable HCC
Masking
None (Open Label)
Allocation
N/A
Enrollment
57 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PD-1 antibody and lenvatinib plus TACE-HAIC
Arm Type
Experimental
Arm Description
systemic PD-1 antibody (Sintilimab) and lenvatinib plus transarterial chemobolization and FOLFOX-based chemotherapy infusion
Intervention Type
Drug
Intervention Name(s)
PD-1 inhibitor
Other Intervention Name(s)
lenvatinib, TACE-HAIC
Intervention Description
systemic PD-1 antibody (Sintilimab) and lenvatinib plus transarterial chemobolization and FOLFOX-based chemotherapy infusion
Primary Outcome Measure Information:
Title
conversion rate to resection
Description
The conversion rate to resection among all the enrolled patients
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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiliang Qiu
Phone
+862087343114
Email
qiujl@sysucc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yunfei Yuan
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
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
Jiliang Qiu
Phone
+862087342651
Email
qiujl@sysucc.org.cn

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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