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

Phase 2

• Conditions: Hepatocellular Carcinoma
• Interventions: Combination Product: TAI combine SBRT

• Registration Number: NCT03851887
• Lead Sponsor: Sun Yat-sen University

Brief Summary

To evaluate the efiicacy of TAI combine SBRT in unresectable HCC

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-01
• Status Verified: 2019-02
• Study First Submitted: 2019-02-21
• Study First Submitted QC: 2019-02-21
• Last Update Submitted: 2019-02-21
• Study First Posted: 2019-02-22
• Last Update Posted: 2019-02-22
• Primary Completion: 2020-01-31
• Study Completion: 2022-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 33

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 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
treatment group	TAI combine SBRT	TAI combine SBRT

Primary Outcome Measures

Name	Time	Method
PFS	From date of randomization until the date of progression, assessed up to 36 months	progression-free survival
ORR	From date of randomization until the date of death, assessed up to 36 months	objective response rate

Secondary Outcome Measures

Name	Time	Method
OS	From date of randomization until the date of death from any cause, assessed up to 36 months	overall survival
DCR	From date of randomization until the date of death, assessed up to 36 months	disease control rate

Trial Locations

Locations (1)

SUN YAT-SEN University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China