The Efficacy of Transarterial Chemoinfusion (TAI) Combine Toripalimab in Advanced Hepatocellular Carcinoma (HCC)
1 other identifier
interventional
65
1 country
1
Brief Summary
To evaluate the efficacy of TAI combine toripalimab in advanced HCC.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 hepatocellular-carcinoma
Started Feb 2019
Shorter than P25 for phase_2 hepatocellular-carcinoma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2019
CompletedFirst Posted
Study publicly available on registry
February 22, 2019
CompletedStudy Start
First participant enrolled
February 26, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2021
CompletedFebruary 22, 2019
February 1, 2019
1 year
February 21, 2019
February 21, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
PFS
progression-free survival
From date of randomization until the date of progression, assessed up to 36 months
ORR
objective response rate
From date of randomization until the date of death, assessed up to 36 months
Secondary Outcomes (2)
OS
From date of randomization until the date of death from any cause, assessed up to 36 months
DCR
From date of randomization until the date of death, assessed up to 36 months
Study Arms (1)
treatment group
EXPERIMENTALTransarterial Chemoinfusion (TAI) Combine Toripalimab
Interventions
Transarterial Chemoinfusion (TAI) Combine Toripalimab
Eligibility Criteria
You may qualify if:
- 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;
- +2 more criteria
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
SUN YAT-SEN University Cancer Center
Guangzhou, Guangdong, 510060, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
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
Study Record Dates
First Submitted
February 21, 2019
First Posted
February 22, 2019
Study Start
February 26, 2019
Primary Completion
March 1, 2020
Study Completion
March 1, 2021
Last Updated
February 22, 2019
Record last verified: 2019-02