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

Sun Yat-sen University

Status and phase: Unknown; Phase 2

Conditions: Hepatocellular Carcinoma

Treatments: Combination Product: TAI combine SBRT

Study type: Interventional

Funder types: Other

Identifiers

NCT03851887

B2019-002-01

Details and patient eligibility

About

To evaluate the efiicacy of TAI combine SBRT in unresectable HCC

Enrollment: 33 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

treatment group

Experimental group

Description:

TAI combine SBRT

Treatment:

Combination Product: TAI combine SBRT