Clinical trial · Interventional
Evaluation of Hepatic Arterial Infusion of Cisplatin and 5-FU in Biomarker Stratified HCC
Single-arm, Prospective, Multicenter Clinical Trial to Assess the Efficacy and the Safety of Combination Therapy of Hepatic Arterial Infusion of Cisplatin and 5-FU in Advanced Hepatocellular Carcinoma With Low Expression of HMGB2 Biomarker
NCT02967887CI-TRIAL-00028644SHINEunknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is to assess the efficacy and the safety of hepatic arterial infusion of cisplatin and 5-fluorouracil (HAIC) in advanced HCC patients stratified by biomarker expression predicting therapeutic response.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma Non-Resectable | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin and 5-fluorouracil | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- cisplatin and 5-fluorouracil
- description
- Enrolled patients with pre-treatment tumor biopsy will receive Cisplatin (60mg/m2 for 2h on day 2) and 5-fluorouracil (500mg/m2 for 5h on days 1-3) through implanted port system. This treatment will be repeated every 4 weeks, up to 6 times.
- interventionNames
- Drug: cisplatin and 5-fluorouracil
Primary outcomes (1)
- measure
- Objective tumor response
- timeFrame
- Approximately 6 months
- description
- Objective tumor response according to Modified Response Evaluation Criteria in Solid Tumors (mRECIST) assessed by radiological review
Secondary outcomes (2)
- measure
- Time-to-Progression
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * over 20 years old * Patients with advanced hepatocellular carcinoma who have progressed or intolerance to Sorafenib * Patients with advanced hepatocellular carcinoma who cannot be treated with surgery, transplantation, RFA, or TACE. * TNM stage III/IV (including intrahepatic single or multiple tumors without extrahepatic metastasis regardless of lymph node metastasis) * ECOG performance status of 0 or 1 * Liver function status of Child-Pugh Class A or B * more than 3 months of life expectancy * serum creatinine \<1.5 mg/dL * aminotransferase \<5 times the upper limit of normal * absolute neutrophil count \>1,500 cells/lL * platelet count \>75,000/lL * hemoglobin \>10 g/dL Exclusion Criteria: * patients with extrahepatic tumors * Patients requiring combined treatment with chemotherapy, radiotherapy, TACE, RFA, or others * Patients in any severe and/or uncontrolled medical conditions * patients with history of allergic response to CT contrast media * patients who participated as subjects in other interventional clinical studies (as of the date of visit) within 60 days before drug administration * Any person deemed inappropriate by reason of the investigator for other reasons
References
Publications (0)
Data not yet available
No reference posted for this study.