Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Efficacy of Transarterial Chemoinfusion (TAI) Combine Toripalimab in Advanced Hepatocellular Carcinoma (HCC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03851939
Recruitment Status : Unknown
Verified February 2019 by Rong-ping Guo, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : February 22, 2019
Last Update Posted : February 22, 2019
Sponsor:
Information provided by (Responsible Party):
Rong-ping Guo, Sun Yat-sen University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
To evaluate the efficacy of TAI combine toripalimab in advanced HCC.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Combination Product: Transarterial Chemoinfusion (TAI) Combine Toripalimab Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy of Transarterial Chemoinfusion (TAI) Combine Toripalimab in Advanced Hepatocellular Carcinoma (HCC): A Prospective, Single-armed, Stage II Clinical Trial
Estimated Study Start Date : February 26, 2019
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : March 1, 2021
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: treatment group
Transarterial Chemoinfusion (TAI) Combine Toripalimab
 Combination Product: Transarterial Chemoinfusion (TAI) Combine Toripalimab
Transarterial Chemoinfusion (TAI) Combine Toripalimab


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. PFS [ Time Frame: From date of randomization until the date of progression, assessed up to 36 months ]
    progression-free survival

  2. ORR [ Time Frame: From date of randomization until the date of death, assessed up to 36 months ]
    objective response rate


Secondary Outcome Measures :
  1. OS [ Time Frame: From date of randomization until the date of death from any cause, assessed up to 36 months ]
    overall survival

  2. DCR [ Time Frame: From date of randomization until the date of death, assessed up to 36 months ]
    disease control rate


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • older than 18 years old and younger than 75 years;
  • ECOG PS≤1;
  • proven advanced hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria;
  • not previous treated for tumor;
  • cannot accepted hepatectomy;

  • the lab test could meet:

    • neutrophil count≥2.0×109/L;
    • hemoglobin≥100g/L;
    • platelet count≥75×109/L;
    • serum albumin≥35g/L;
    • total bilirubin<2-times upper limit of normal;
    • ALT<3-times upper limit of normal;
    • AST<3-times upper limit of normal;
    • serum creatine<1.5-times upper limit of normal;
    • PT≤upper limit of normal plus 4 seconds;
    • INR≤2.2;
  • sign up consent;

Exclusion Criteria:

  • cannot tolerate TAI or toripalimab;
  • known history of other malignancy;
  • be allergic to related drugs;
  • underwent organ transplantation before;
  • be treated before (interferon included);
  • known history of HIV infection;
  • known history of drug or alcohol abuse;
  • have GI hemorrhage or cardiac/brain vascular events within 30 days;
  • pregnancy;
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT03851939


Contacts
Layout table for location contacts
Contact: Shaohua Li, MD +8615088064187 lishaoh@sysucc.org.cn

Locations
Layout table for location information
China, Guangdong
SUN YAT-SEN University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Rong-Ping Guo, M.D.    00862087342266    guorp@sysucc.org.cn   
Contact: Wei Wei, Ph.D. M.D.    00862087343790    weiwei@sysucc.org.cn   
Sponsors and Collaborators
Sun Yat-sen University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Rong-ping Guo, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03851939    
Other Study ID Numbers: B2018-158-01
First Posted: February 22, 2019    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: February 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
 Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases