Phase I/II study of transcatheter arterial chemo-embolization with DDP-H and degradable starch microspheres for hepatic metastases of colorectal cancer

Phase I/II study of transcatheter arterial chemo-embolization with DDP-H and degradable starch microspheres for hepatic metastases of colorectal cancer - Phase I/II study of transcatheter arterial chemo-embolization with DDP-H and degradable starch microspheres for hepatic metastases of colorectal cancer

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001168

Enrollment

Registered

2008-06-02

Start date

2008-02-01

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

Colorectal Cancer

Interventions

The protocol in the clinical trial repeatedly makes up treatment couses which is constituted DPP-H and DSM mixing solution injects into hepatic artery until the embolization appears conducts every 4

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed colorectal carcinoma with unresectable liver metastases. 2. Metastatic hepatic lesion as the most prior prognostic factor. 3. Refractory with standard chemotherapy or contraindication of chemotherapy. No history of chemotherapy 2 weeks before. 4. Existing measurable hepatic lesion Response Evaluation Criteria in Solid Tumor (RECIST) is applicable (More than two times thickness slice resolution with CT). 5. Performance Status (ECOG): 0,1,2 6. Adequate organ functions: bone marrow, Heart, renal function (2 weeks before entry) WBC: 3000/mm3-12000/mm3 Plt: >=7.5x104/mm3 T-Bil: <=2.5mg/dl Serum Cre: <=1.5mg/dl BUN: <=25mg/dl PT: >=50% 7. Age: 20 to 80 yrs 8. Expected survival time over 8 weeks 9. Written informed consent

Exclusion criteria

Exclusion criteria: 1) Reconstruction of the biliary tract history 2) Severe complication (Cardiac failure, Myocardial infarction, Pulmonary fibrosis, Interstitial pneumonia, Uncontrollable diabetic, Renal failure) 3)Active infection (Hepatitis C virus is permitted) 4) Active double cancer 5) Hyper sensitivity history with iodin contrast medium or platinum related substance, or starch 6) Pregnant, nursing or possible pregnant woman 7) Heparic artery occlusion under CT angiography or angiography (Registration after qualification with CT angiography. Judging occlusion under angiography, including reservoir DAS, in case unqualified judgement with CT angiography) 8) Qualified ineligible patients being this clinical trial by responsible doctor

Design outcomes

Primary

Measure	Time frame
Dose Limiting Toxicity,Recommended Dose	—

Secondary

Measure	Time frame
Adverse events, Response rate, Overall survival, Progression free survival	—

Countries

Japan

Contacts

Public ContactHideyuki Nishiofuku

Nara Medical University Hospital Radiology

hmn@naramed-u.ac.jp0744-29-8900

Outcome results

None listed

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