Oxaliplatin-hepatic arterial infusion chemotherapy (OXA-HAIC) plus Tiji'ao for treatment of advanced hepatocellular carcinoma (HCC) with portal vein tumor thrombus

Status

Recruiting

Phases

Phase 2

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR-OIC-16007966

Enrollment

Unknown

Registered

2016-02-22

Start date

2016-03-01

Completion date

Unknown

Last updated

2017-04-18

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:OXA-HAIC plus Tiji'ao

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Prior informed consent; 2. Confirmed Diagnosis of HCC: 2.1. Cirrhotic subjects: Clinical diagnosis by AASLD criteriaHCC can be defined in cirrhotic subjects by one imaging technique (CT scan, MRI, or second generation contrast ultrasound) showing a nodule larger than 2 cm with contrast uptake in the arterial phase and washout in venous or late phases or two imaging techniques showing this radiological behavior for nodules of 1-2 cm in diameter. Cytohistological confirmation is required for subjects who do not fulfill these eligibility criteria; 2.2. Non-cirrhotic subjects: For subjects without cirrhosis, histological or cytological confirmation is mandatory.Documentation of original biopsy for diagnosis is acceptable; 3. BCLC stage C HCC with portal vein tumor thrombus; 4. Child Pugh class == 18 years of age; 8. Ability to swallow oral medications; 9. Life expectancy of at least 12 weeks; 10. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and 4 weeks after the completion of trial; Adequate bone marrow, liver and renal function as assessed by central lab by means of the following laboratory requirements from samples within 7 days prior to randomization: Hemoglobin > 9.0 g/dl; Absolute neutrophil count (ANC) >1,500/mm3; Platelet count 50*10^9/L; ALB>=28g/L; Total bilirubin < 2 mg/dL; ALT and AST < 5*upper limit of normal; BUN and creatinine < 1.5*upper limit of normal; INR < 1.7, or PT < 4 seconds above control.

Exclusion criteria

Exclusion criteria: 1. Biliary tract obstruction; 2. Any contraindications for hepatic embolization procedures(known hepatofugal blood flow,known portal-systemic shunt, renal failure/insufficiency requiring hemo-or peritoneal dialysis); 3. Previous or concurrent cancer that is distinct in primary site or histology from HCC. Any cancer curatively treated >3 years prior to entry is permitted.

Design outcomes

Primary

Measure	Time frame
Adverse reactions;time to progress;	—

Secondary

Measure	Time frame
OS;DCR;	—

Countries

China

Contacts

Public ContactWukui Huang

huangwukui1982@sina.com+86 15909911798

Outcome results

None listed

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