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Not yet recruitingNCT06021015Updated Sep 1, 2023

Safety and Efficacy of Polyvinyl Alcohol Sodium Acrylate Embolization Microspheres for CRLM

An interventional study of Irinotecan and polyvinyl alcohol sodium acrylate embolization microspheres(Unipearls®) and Irinotecan and HepaSphere Microspheres in Colorectal Cancer Liver Metastasis, sponsored by Zhongda Hospital. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-09-01.

Sponsored by Zhongda Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 3 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
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Study summary

This study is a prospective, multicenter, randomized controlled clinical trial to evaluate the safety and efficacy of polyvinyl alcohol sodium acrylate embolization microspheres and HepaSphere Microspheres loaded with irinotecan for the treatment of colorectal cancer with hepatic metastases through arterial chemoembolization.

Read the detailed description

This study is a prospective, multicenter, randomized controlled clinical trial. Seventy-two patients with colorectal cancer liver metastases that are not feasible or suitable for surgical resection will be enrolled in this study. The experimental group received transcatheter arterial chemoembolization (TACE) treatment with polyvinyl alcohol sodium acrylate embolization microspheres loaded with 100mg irinotecan and the control group received TACE treatment with HepaSphere Microspheres loaded with 100mg irinotecan. All patients received 1-2 TACE treatment as needed. The primary end point of this study is disease control rate (DCR) of target lesions 1 month after the last TACE treatment.

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Conditions studied

  • Colorectal Cancer Liver Metastasis

Keywords

  • colorectal cancer
  • liver metastasis
  • embolization microspheres
  • efficacy
  • safety
  • transcatheter arterial chemoembolization
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In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's planned enrollment of 72 is close to the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Zhongda Hospital is the lead sponsor of 101 studies on the registry; 40 are open to participants now.

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

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age range from 18 to 80 years old (including threshold), regardless of gender;
  2. Imaging or pathology/cytology clearly diagnosed as colorectal cancer liver metastases, with complete resection of the primary lesion and no local recurrence;
  3. Researchers believe that liver metastases are not feasible or suitable, or patients refuse surgical resection;
  4. ECOG score ≤ 2 points, Child Pugh grade A or B;
  5. At least one measurable liver metastasis with a diameter greater than 1 cm without embolization treatment (the maximum diameter of the target lesion is less than 10 cm);
  6. Voluntarily participate in this clinical trial and sign the informed consent form.

Exclusion criteria

Exclusion Criteria:

  1. Patients with known severe allergy to contrast agents (iodine contrast agents, gadolinium contrast agents, etc.) or embolic materials (polyvinyl alcohol sodium acrylate copolymer) ;
  2. White blood cell count\<3.0×109/L, platelet count\<75×109/L,hemoglobin\<70 g/L;
  3. Total bilirubin>2 times the upper limit of normal value, Alanine transaminase (ALT) or aspartate aminotransferase (AST) >5 times the upper limit of normal value, Alkaline phosphatase>2.5 times the upper limit of normal value, albumin\<30 g/L;
  4. Creatinine>1.5 times the upper limit of normal value, creatinine clearance rate\<30 mL/min;
  5. Prothrombin time and activated partial thromboplastin time>1.5 times the upper limit of normal value;
  6. Target lesion blood supply artery cannot undergo TACE treatment (the blood supply artery is too thin,vasospasm or suspected vasospasm,peripheral vascular resistance of the blood supply artery hinders the entry of embolic microspheres into the lesion site,severe Atherosclerosis, etc) or there is a risk of embolism (collateral vascular pathway endangers normal areas, etc);
  7. The expected survival time is less than 3 months;
  8. Patients who have received embolization therapy for the target lesion or undergo the first TACE treatment for the target lesion after enrollment and require combined ablation/radiotherapy;
  9. Pregnant and lactating women, or those who plan to conceive during the study period;
  10. Those who have participated in other intervention clinical trials within one month before the trial;
  11. The researchers believe that the subjects are intolerant and other unsuitable candidates for participating in this clinical trial.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
72 participants (estimated)

Study arms

  • Experimental
    Experimental group

    Irinotecan and polyvinyl alcohol sodium acrylate embolization microspheres(Unipearls®)

    Device: Irinotecan and polyvinyl alcohol sodium acrylate embolization microspheres(Unipearls®)

  • Active comparator
    Control group

    Irinotecan and HepaSphere Microspheres

    Device: Irinotecan and HepaSphere Microspheres

Interventions

  • DeviceIrinotecan and polyvinyl alcohol sodium acrylate embolization microspheres(Unipearls®)

    Irinotecan and polyvinyl alcohol sodium acrylate embolization microspheres(Unipearls®)

  • DeviceIrinotecan and HepaSphere Microspheres

    Irinotecan and HepaSphere Microspheres

06

What researchers measure

Primary outcomes

  1. Disease control rate (DCR) of target lesions 1 month after the last TACE treatment

    Disease control rate (DCR) of target lesions 1 month after the last TACE treatment

    Time frame: 3 month

Secondary outcomes

  1. Success rate

    The success rate of embolization techniques for target lesions

    Time frame: 3 month

  2. Disease control rate (DCR) of target lesions 1 month after first TACE treatment

    Disease control rate (DCR) of target lesions 1 month after first TACE treatment

    Time frame: 1 month

  3. Objective response rate (ORR)

    Objective response rate (ORR) of target lesions 1 month after the first TACE treatment and 1 month after the last TACE treatment

    Time frame: 3 month

  4. Equipment performance evaluation

    Equipment performance evaluation: evaluation of conveying performance and degree of embolism

    Time frame: 3 month

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06021015
Lead sponsor
Zhongda Hospital
Responsible party
Gao-jun Teng (Professor, Zhongda Hospital) — Principal investigator
First posted
Sep 1, 2023
Start date
Sep 10, 2023 (estimated)
Primary completion
Jun 30, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Sep 1, 2023

Study contacts

Jian Lu, MD
Contact
lujian43307131@126.com
+8615850654644
Gao-Jun Teng, MD
principal investigator · Zhongda Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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