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A random controlled trial for comparing conventional transarterial chemoembolization plus hepatic artery infusion chemotherapy with conventional transarterial chemoembolization in intermediate-advanced stage HCC patients:evaluation of efficacy and safety

A random controlled trial for comparing conventional transarterial chemoembolization plus hepatic artery infusion chemotherapy with conventional transarterial chemoembolization in intermediate-advanced stage HCC patients:evaluation of efficacy and safety

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900026751
Enrollment
Unknown
Registered
2019-10-20
Start date
2019-11-01
Completion date
Unknown
Last updated
2019-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Interventions

Group 1:conventional TACE
Group 2:cTACEcombined with HAIC

Sponsors

Zhongshan Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. clinical or pathological diagnosis of HCC; 2. unresectable stage B / C liver cancer of BCLC; 3. at least one measurable target lesion; 4. ECoG score 0-2; 5. liver function status is child Pugh a or B; 6. the life expectancy shall be at least 3 months; 7. at least 18 years old, no more than 85 years old, gender unlimited; 8. women patients of childbearing age and men patients shall agree to adopt birth control measures since the signing of informed consent; 9. requirements for bone marrow function, liver function and kidney function of patients: (1) Hemoglobin concentration >85 g/L; (2) Peripheral blood WBC >=3x10^9/L; (3) Platelet count >=50x10^9/L; (4) Total bilirubin concentration =28 g/L; (6) ALT and AST <=5 ULN; (7) Prothrombin time international standard ratio (PT-INR) < 2.3 ULN; (8) Serum creatinine <=1.5 ULN.

Exclusion criteria

Exclusion criteria: 1. uncontrollable infection; 2. cholangiocarcinoma or mixed cell carcinoma with other tumors; 3. history of drug allergy; 4. HIV infection; 5. pregnancy; 6. within the first 30 days, patients with severe bleeding symptoms or with a clear tendency of gastrointestinal bleeding (fecal occult blood + + or above can not be included in the group).

Design outcomes

Primary

MeasureTime frame
overall survival;

Secondary

MeasureTime frame
progression-free survival;TTP;ORR;AFP response;DCR;Safety;

Countries

China

Contacts

Public ContactChen Rongxin

Zhongshan Hospital of Fudan University

chenrongxin99@126.com+86 13916988702

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026