The Efficacy of Transarterial Chemoinfusion (TAI) Combine Stereotactic Body Radiation Therapy (SBRT) in Unresectable Hepatocellular Carcinoma (HCC)

NCT03851887 | Unknown Phase 2

• 1 other identifier: B2019-002-01
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efiicacy of TAI combine SBRT in unresectable HCC

Conditions

Hepatocellular Carcinoma

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

EXPERIMENTAL

TAI combine SBRT

Combination Product: TAI combine SBRT

Interventions

TAI combine SBRT COMBINATION_PRODUCT

TAI combine SBRT

treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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;

You may not qualify if:

• cannot tolerate TAI or SBRT;
• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

SUN YAT-SEN University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

Shaohua Li, MD

CONTACT

+8615088064187; lishaoh@sysucc.org.cn

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: December 1, 2018
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2022
• Last Updated: February 22, 2019

Record last verified: 2019-02

Locations

CN (1)