Skip to content

Preoperative chemotherapy followed by hepatic resection for resectable UICC7 StageIIIA, IIIB hepatocellular carcinoma, A phase II clinical trial

Preoperative chemotherapy followed by hepatic resection for resectable UICC7 StageIIIA, IIIB hepatocellular carcinoma, A phase II clinical trial - Preoperative chemotherapy for resectable UICC7 StageIII HCC

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000030739
Enrollment
25
Registered
2018-01-09
Start date
2016-11-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

hepatocellular carcinoma

Interventions

As a preoperative chemotherapy, hepatic arterial infusion chemotherapy (HAIC) is performed, regimen of HAIC is New FP therapy. Angiography is performed on Day 1 as induction New FP and bolus injection

Sponsors

Kurume University, Department of Surgery, Division of Hepatobilliary and Pancreatic Surgery
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) A case of aged> or =20 years old. 2) Cases of UICC7 StageIIIA, IIIB diagnosed as hepatocellular carcinoma histologically or clinically (imaging diagnosis, tumor marker). 3) Cases of UICC7 StageIIIA, IIIB which can initially perform R0 resection at diagnosis. 4) Cases in which patient consent was obtained in the document after adequate explanation by the attending physician. 5) Patients who can expect survival for more than 3 months. 6) ECOG performance status 0 or 1. 7) Patients who had been preserved adequate major organ functions within 2 weeks before registration (bone marrow, heart, liver, kidney, etc.). Neutrophils> or =1000/mm3 Hb> or =8.5 g/dl Platelet> or =75,000/mm3 AST and ALT< or =200 IU/L Child-Pugh score 7 points or less Total bilirubin 3 mg/dl or less (Excluded after reduction of jaundice cases due to bile duct tumor obstructions) No refractory ascites or hepatic encephalopathy Other major organ functions are well preserved

Exclusion criteria

Exclusion criteria: 1) Patients with history of advanced cancer in other organs within 5 years. 2) A patient who has history of chemotherapy of a regimen including CDDP or 5-FU. 2) Active infectious diseases (except for viral hepatitis) 3) Patients who have a history of allergy to iodine contrast agent, platinum-containing drug, or gelatin-containing drug / food. 4) Pregnant women, breast-feeding women and patients who may be pregnant. Patients who are determined by the attending physician to be inappropriate for this examination for other reasons (in cases where the patient does not obey the instructions or has problems with family cooperation etc.).

Design outcomes

Primary

MeasureTime frame
The 3 years disease free survival rate after liver surgery

Secondary

MeasureTime frame
Overall survival, disease free survival, response to the preoperative chemotherapy, incidence and degree of side effects of preoperative chemotherapy

Countries

Japan

Contacts

Public ContactYuichi Goto

Kurume University Department of Surgery, Division of Hepatobilliary and Pancreatic Surgery

gotou_yuuichi@med.kurume-u.ac.jp0942-31-7567

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026