Status unknownNCT04912258Updated Jun 3, 2021

Preoperative Irinotecan Drug-eluting Beads for Patients With Unresectable Colorectal Liver Metastasis

A Phase 3 interventional study of Trans arterial chemoembolization with Irinotecan Drug-eluting Beads in Colorectal Cancer and Liver Metastases, sponsored by Fudan University. Status unknown at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-06-03.

Sponsored by Fudan University · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2021), so the status shown — last known as Not yet recruiting — may be out of date.

Phase: Phase 3
Study type: Interventional
Enrollment: 80
Allocation: Randomized
Ages: 18 Years to 85 Years
Sex: All

Study summary

Trans arterial chemoembolization using Irinotecan Drug-eluting Beads before liver surgery for patients with primarily unresectable colorectal liver metastasis

Conditions studied

Colorectal Cancer
Liver Metastases

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In context

Neoplasm Metastasis

3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.

This study's planned enrollment of 80 is above the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.

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Lead sponsor

Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 85 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Age ≥ 18 years;
Histologically proven colorectal liver metastasis；
With liver-dominant disease；
Primarily evaluated as potentially resectable and conversed successfully
Adequate hematologic function: absolute neutrophil count (ANC)≥1.5×109/l, platelets≥75×109/l, and international normalized ratio (INR) ≤1.3 (within 1 week prior to randomization)
Adequate liver and renal function: total bilirubin ≤2.0 mg/dl, alanine aminotransferase, aspartate aminotransferase ≤ 5x upper limit of normal, and albumin≥2.5 g/dl, serum creatinine≤2.0 mg/dl (within 1 week prior to randomization);
Written informed consent for participation in the trial.

Exclusion criteria

Exclusion Criteria:

Primarily evaluated as resectable
Failed to converse
Patients with known hypersensitivity reactions to any of the components of the study treatments.
Pregnancy (absence confirmed by serum/urine β-HCG) or breast-feeding
Other previous malignancy within 5 years
Known drug abuse/ alcohol abuse
Legal incapacity or limited legal capacity

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Care provider)
Enrollment: 80 participants (estimated)

Study arms

Experimental
Arm A
DEB-TACE before liver surgery
Drug: Trans arterial chemoembolization with Irinotecan Drug-eluting Beads
No intervention
Arm B
direct liver surgery

Interventions

DrugTrans arterial chemoembolization with Irinotecan Drug-eluting Beads
preoperative chemoembolization with Irinotecan Drug-eluting Beads
Also known as: Irinotecan Drug-eluting Beads

What researchers measure

Primary outcomes

liver relapse-free survival
from liver surgery to liver relapse
Time frame: 6 months

Secondary outcomes

relapse-free survival
Time frame: 6 months
overall survival
Time frame: 12 months
response rate
Time frame: 2 months

Study locations

1 site

Zhongshan Hospital Fudan University
Shanghai, Shanghai 200032, China
- Jianmin Xu · Contact · 13301050195@fudan.edu.cn · 18834823867

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 3, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04912258
Lead sponsor: Fudan University
Responsible party: Sponsor
First posted: Jun 3, 2021
Start date: Aug 1, 2021 (estimated)
Primary completion: Dec 1, 2022 (estimated)
Completion: Jun 1, 2023 (estimated)
Last update: Jun 3, 2021

Study contacts

Jianmin Xu

Contact

xujmin@aiiyun.com

+8613501984869 ext. +8613501984869

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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