Evaluation of efficacy and safety of continuous hepatic artery infusion chemotherapy in hepatocellular carcinoma patients with TACE failure or unsuitable for TACE therapy

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900026754

Enrollment

Unknown

Registered

2019-10-20

Start date

2020-07-01

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

Case series:continuous hepatic artery infusion chemotherapy

Eligibility

Sex/Gender

All

Age

18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. clinical or pathological diagnosis of HCC; 2. patients with stage B / C liver cancer of BCLC who can't be resected, unsuitable / intolerant to interventional therapy or failed in interventional therapy. Unsuitable intervention criteria: portal vein cancer thrombus or severe arteriovenous fistula, hepatic vein or inferior vena cava cancer thrombus, bile duct cancer thrombus or diffuse liver cancer; Failure criteria of interventional therapy (refer to Japanese standards): incomplete necrosis (tumor activity still > 50%) or new lesions were found in the intrahepatic lesions after twice or more TACE treatment; vascular invasion occurred during follow-up; tumor thrombus progression; AFP or abnormal DCP continued to rise; extrahepatic metastasis occurred. 3. at least one untreated and measurable target lesion; 4. ECOG score is 0-2; 5. Child-Pugh Score A or B. 6. the life expectancy shall be at least 3 months. 7. male or female patients aged = 18 and = 85. 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. the history of other tumors other than the previous or concurrent ICC; 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

Measure	Time frame
OS;	—

Secondary

Measure	Time frame
PFS;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