A clinical study on safety and efficacy of System-i as new indwelling catheter system for hepatic arterial chemotherapy.

A clinical study on safety and efficacy of System-i as new indwelling catheter system for hepatic arterial chemotherapy. - A clinical study on safety and efficacy of System-i for hepatic arterial chemotherapy.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000016887

Enrollment

Registered

2015-03-24

Start date

2015-03-28

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

The new indwelling catheter system (System-i) is embedded and TACE or TAI is performed from it.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histology/cytology-or clinically (by imaging or tumor marker) proven advanced hepatocellular carcinoma 2) ECOG performance status 0 or 1. 3) 20 years of age or older. 4) Liver function is preserved. 5) The function of the major organ is kept as satisfied by the following requirement, a) WBC (Neutrophil) >= 3,000 (1,500)/microL b) d) Cr<=2.0 *Upper limit of Normal(ULN) 6) Obtained written consent from the patient before study.

Exclusion criteria

Exclusion criteria: 1) ECOG performance status 3. 2) Uncontrollable extra-hepatic metastasis. 3) Symptomatic or under medication cardiac disease. 4) Having other cancer. 5) Having severe dysfunction (HCC rapture, uncontrolled diabetes, heart failure, MI, Arrhythmia, etc). 6) Having possibility of pregnant or nursing. 7) Deemed inappropriate to perform the study by the physician.

Design outcomes

Primary

Measure	Time frame
Success rate of therapy (TACE or TAI) and safety	—

Secondary

Measure	Time frame
Implantation time of system response rate complication (liver dysfunction, stenosis of catheter)	—

Countries

Japan

Contacts

Public ContactYuuta Abe

Department of surgery, Keio University, school of medicine Department of Surgery

abey3666@gmail.com03-3353-1211

Outcome results

None listed

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