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

Hepatocellular Carcinoma Clinical Trial

Official title:

The Efficacy of Transarterial Chemoinfusion (TAI) Combine Toripalimab in Advanced Hepatocellular Carcinoma (HCC): A Prospective, Single-armed, Stage II Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03851939
• Other study ID #: B2018-158-01
• Status: Recruiting
• Phase: Phase 2
• Start date: February 26, 2019
• Est. completion date: March 1, 2021

Study information

• Verified date: February 2019
• Source: Sun Yat-sen University
• Contact: Shaohua Li, MD
• Phone: +8615088064187
• Email: lishaoh[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the efficacy of TAI combine toripalimab in advanced HCC.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: March 1, 2021
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Combination Product:
• Transarterial Chemoinfusion (TAI) Combine Toripalimab
Transarterial Chemoinfusion (TAI) Combine Toripalimab

Locations

Country	Name	City	State
China	SUN YAT-SEN University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS	progression-free survival	From date of randomization until the date of progression, assessed up to 36 months
Primary	ORR	objective response rate	From date of randomization until the date of death, assessed up to 36 months
Secondary	OS	overall survival	From date of randomization until the date of death from any cause, assessed up to 36 months
Secondary	DCR	disease control rate	From date of randomization until the date of death, assessed up to 36 months