TANDEM-IRI-TACE combined with systemic FOLFIRI for colorectal liver metastases after oxaliplatin regimen failure: Phase I dose escalation study

TANDEM-IRI-TACE combined with systemic FOLFIRI for colorectal liver metastases after oxaliplatin regimen failure: Phase I dose escalation study - TANDEM-IRI-TACE

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000015367

Enrollment

Registered

2014-10-08

Start date

2014-09-01

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

Colorectal Cancer

Interventions

TACE will be conducted every 5 weeks. Systemic FOLFIRI will be conducted every 2 weeks.

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 oxaliplatin based-chemotherapy. No history of chemotherapy 2 weeks before. 4. Existing measurable hepatic lesion Response Evaluation Criteria in Solid Tumor (RECIST) or modified RECIST is applicable (More than two times thickness slice). 5. Performance Status (ECOG): 0,1,2 6. Adequate organ functions: bone marrow, Heart, renal function (2 weeks before entry) WBC (or Neut): >= 3000/mm3 (or >=1500/mm3) Plt: >=7.5x104/mm3 T-Bil: <=2.5mg/dl Serum Cre: <=1.2mg/dl AST: < 5 times ULN ALT: < 5 times ULN 7. Age: more than 20 y.o 8. Expected survival time over 8 weeks 9. Written informed consent

Exclusion criteria

Exclusion criteria: 1 Previous pancreato-biliary surgery or post endoscopic sphincteropapillotomy 2. Serious complications 3. Concomitant malignancy 4. A history of allergy to iodine containing agents or contrast media, irinotecan and 5FU 5. Presence of remarkable AP shunts or AV shunts 6. UGT1A1 6, UGT1A1 28

Design outcomes

Primary

Measure	Time frame
Dose Limiting Toxicity,Recommended Dose	—

Secondary

Measure	Time frame
pharmacokinetics of irinotecan, tumor response, progression free survival, overall survival	—

Countries

Japan

Contacts

Public ContactToshihiro Tanaka

Nara Medical University Hospital Radiology and IVR Center

toshihir@bf6.so-net.ne.jp+81-744-22-3051

Outcome results

None listed

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