CClinicalTrials.gg
Status unknownNCT05770635Updated Mar 15, 2023

Polyvinyl Alcohol Embolization Microspheres

An interventional study of Embosphere and chemotherapy drug and Polyvinyl alcohol embolization microspheres (Huihe Medical) and chemotherapy drug in Primary Liver Cancer, sponsored by Shanghai Huihe Medical Technology Co., Ltd. Status unknown at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-03-15.

Sponsored by Shanghai Huihe Medical Technology Co., Ltd · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2023), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
224
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study summary

To evaluate the safety and efficacy of polyvinyl alcohol embolization microspheres developed and manufactured by Shanghai Huihe Medical Technology Co., LTD. (hereinafter referred to as Huihe Medical) for transarterial chemoembolization of primary liver cancer using a prospective, multi-center, randomized controlled method

02

Conditions studied

  • Primary Liver Cancer

Browse trials for

03

In context

Liver Neoplasms

1,391 studies on the registry are indexed under Liver Neoplasms; 345 are open to participants now.

This study's planned enrollment of 224 is above the median of 47 across 968 interventional studies indexed under Liver Neoplasms.

Browse Liver Neoplasms studies →

Lead sponsor

Shanghai Huihe Medical Technology Co., Ltd is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

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

04

Who can participate

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

Inclusion criteria

  1. Age≥18 years old; age ≤85 years old; regardless of gender
  2. Patients with CNLC Ib, IIa, IIb, IIIa who need transarterial chemoembolization (TACE) therapy and are not suitable for or refuse surgical resection, liver transplantation, and ablation, and patients with stage IIIb primary liver cancer who are expected to benefit from TACE therapy to control the growth of intrahepatic tumors;
  3. Child-Pugh A or B (less than 10 points);
  4. performance status (PS) score of ECOG 0\~2;
  5. The patient had at least one measurable tumor lesion without embolization (maximum diameter of the target lesion ≤10cm);
  6. Those who agree to participate in the clinical trial and voluntarily sign the informed consent;

Exclusion criteria

Exclusion Criteria:

  1. Patients whose target lesions had received embolization therapy, whose target lesions had received other local treatments besides TACE (including but not limited to surgery, radiotherapy, hepatic arterial perfusion, radiofrequency ablation, cryoablation or percutaneous ethanol injection) within 1 month, or who had received first TACE therapy for target lesions combined with ablation/radiotherapy after inclusion;
  2. The proportion of tumor in total liver volume was ≥70%;
  3. Patients with distant extensive metastasis or other malignant tumors;
  4. The expected survival time is less than 3 months;
  5. Cachexia or multiple organ failure;
  6. Severe liver dysfunction (Child-Pugh grade C), including jaundice, hepatic encephalopathy, refractory ascites, or hepatorenal syndrome;
  7. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 times the upper limit of normal or >250U/L, and ≥2 times the upper limit of normal after 1 week of liver protection and antiviral treatment;
  8. Renal dysfunction: patients with serum creatinine > 2mg/dL;
  9. Blood leukocytes and platelets decreased significantly, leukocytes \< 3.0×109/L, platelets \< 50×109/L (except patients with hyperplenism and chemotherapy myelosuppression);
  10. Bleeding and thrombotic tendency: patients with known hereditary or acquired bleeding and thrombotic tendency (e.g., hemophiliacs, uncorrectable coagulation disorders, thrombocytopenia, hyperplenism, etc.), active peptic ulcer or gastrointestinal bleeding within 30 days; Arteriovenous thrombosis occurred in the past 6 months (until enrollment);
  11. Patients with active hepatitis or severe infection who cannot be treated with TACE simultaneously;
  12. Patients with complete obstruction of the main portal vein and unable to restore portal blood flow through compensatory collateral branches of the portal vein;
  13. The target focal blood supply arteries cannot be treated with TACE or have the risk of embolization (vascular access endangers normal areas, arteriovenous fistula, portal fistula, etc.);
  14. Subjects who predicted that the target lesion would require more than three TAces; Uncontrolled diabetes mellitus; 15.
  1. People with known severe allergy to contrast agents, iodine contrast agents or embolic materials; 17. Pregnant/lactating women, or those who plan to give birth; 18. Patients who are participating in clinical trials of other drugs or devices and have not been in the group or have been in the group for less than 1 month; 19. Persons without the ability to make independent decisions or with mental illness; 20. Other patients deemed unsuitable for this clinical trial by the investigator;
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
224 participants (estimated)

Study arms

  • Experimental
    Polyvinyl alcohol embolization microspheres (Huihe Medical) and chemotherapy drug

    The experimental group received chemotherapy drug + polyvinyl alcohol embolized microspheres (Huihe Medical) for target lesion TACE (Trans-Arterial Chemoembolization)treatment.Experimental group and control group were selected to use iodide oil according to the condition of subjects.

    Device: Polyvinyl alcohol embolization microspheres (Huihe Medical) and chemotherapy drug

  • Other
    Embosphere and chemotherapy drug

    Device: Embosphere and chemotherapy drug

Interventions

  • DeviceEmbosphere and chemotherapy drug

    chemotherapeutic drug + embolic Embosphere;Iodide is selected according to the subject's condition

  • DevicePolyvinyl alcohol embolization microspheres (Huihe Medical) and chemotherapy drug

    chemotherapy drug+Polyvinyl alcohol embolization microspheres (Huihe Medical);Iodide is selected according to the subject's condition

06

What researchers measure

Primary outcomes

  1. Objective response rate (ORR) 1 month after the last TACE -mRECIST evaluation

    Target lesions of subjects were treated with TACE for 1-3 times as needed, and the last evaluation of target lesions before enrollment was used as baseline tumor evaluation. One month after the last TACE, all subjects underwent plain CT and enhanced MRI examinations, which were compared with the baseline of target lesions. The efficacy was evaluated according to the mRECIST (Modified Response Evaluation Criteria in Solid Tumors)for the treatment of solid tumors in target foci. For example, multiple tumor foci were embolized at the same time, and the two largest target foci were selected as the evaluation foci:

    Time frame: 1 month after the last TACE -mRECIST evaluation

07

Study locations

1 site
  • Shanghai Huihe Healthcare Tecnology Co.,Ltd.
    Shanghai, Shanghai 201615, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05770635
Lead sponsor
Shanghai Huihe Medical Technology Co., Ltd
Responsible party
Sponsor
First posted
Mar 15, 2023
Start date
Dec 28, 2022
Primary completion
Dec 28, 2024 (estimated)
Completion
Dec 28, 2024 (estimated)
Last update
Mar 15, 2023

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 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion