A phase 1 trial of hepatic arterial infusion chemotherapy with high dose cisplatin and 5-fluorouracil for unresectable advanced and recurrent hepatocellular carcinoma

A phase 1 trial of hepatic arterial infusion chemotherapy with high dose cisplatin and 5-fluorouracil for unresectable advanced and recurrent hepatocellular carcinoma - A phase 1 trial of HAIC with high dose CDDP + 5-FU for advanced HCC

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000015101

Enrollment

Registered

2014-09-10

Start date

2013-09-01

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

hepatocelllar carcinoma

Interventions

Hepatic arterial infusion chemotherapy with high dose CDDP and 5-FU

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histology/cytology-or clinically (by imaging or tumor marker) proven advanced hepatocellular carcinoma 2) ECOG PS of 0 or1 4) Child-Pugh A or B 5) The function of the major organ is kept as satisfied by the following requirement, a) Neutrophil >= 1,500/microL, b) Platelets >=50,000/microL, c) Hemoglobin >= 8.5g/dL d) PT% >=40%, e) AST or ALT <= 5 *Upper limit of Normal(ULN), f) Cr <= 1.5 *ULN 6) written informed consent

Exclusion criteria

Exclusion criteria: (1) Active second primary malignancies. (2) Within 3 years after radical treatment of another cancer (3) With extrahepatic metastasis. (4) Patients with ascites possessed clinical meaning. (5) Hepatic Encephalopathy (6) Critical renal failure or hemodialysis (7) Contraindication of CDDP and 5-FU (8) Any patients are pregnant/ nursing (9) After administration of TS-1 (10) Auditory disorder (11) Patients with serious infection (12) Gastrointestinal ulcer or bleeding (13) Uncontrolled DM (14) Those judged to be not suitable by the attending physician

Design outcomes

Primary

Measure	Time frame
Incidence of dose limiting toxicity	—

Secondary

Measure	Time frame
Adverse effect, response rate, progression free survival, safety	—

Countries

Japan

Contacts

Public ContactOsamu Itano

Keio University, School of medicine Department of Surgery

contact@keio-hpbts.jp03-3353-1211

Outcome results

None listed

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