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Polyvinyl Alcohol Embolization Microspheres

Primary Purpose

Primary Liver Cancer

Status
Enrolling by invitation
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Embosphere and chemotherapy drug
Polyvinyl alcohol embolization microspheres (Huihe Medical) and chemotherapy drug
Sponsored by
Shanghai Huihe Medical Technology Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Liver Cancer

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age≥18 years old; age ≤85 years old; regardless of gender 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; Child-Pugh A or B (less than 10 points); performance status (PS) score of ECOG 0~2; The patient had at least one measurable tumor lesion without embolization (maximum diameter of the target lesion ≤10cm); Those who agree to participate in the clinical trial and voluntarily sign the informed consent; Exclusion Criteria: 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; The proportion of tumor in total liver volume was ≥70%; Patients with distant extensive metastasis or other malignant tumors; The expected survival time is less than 3 months; Cachexia or multiple organ failure; Severe liver dysfunction (Child-Pugh grade C), including jaundice, hepatic encephalopathy, refractory ascites, or hepatorenal syndrome; 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; Renal dysfunction: patients with serum creatinine > 2mg/dL; Blood leukocytes and platelets decreased significantly, leukocytes < 3.0×109/L, platelets < 50×109/L (except patients with hyperplenism and chemotherapy myelosuppression); 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); Patients with active hepatitis or severe infection who cannot be treated with TACE simultaneously; Patients with complete obstruction of the main portal vein and unable to restore portal blood flow through compensatory collateral branches of the portal vein; 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.); Subjects who predicted that the target lesion would require more than three TAces; Uncontrolled diabetes mellitus; 15. 16. 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;

Sites / Locations

  • Shanghai Huihe Healthcare Tecnology Co.,Ltd.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Polyvinyl alcohol embolization microspheres (Huihe Medical) and chemotherapy drug

Embosphere and chemotherapy drug

Arm Description

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.

Outcomes

Primary Outcome Measures

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:

Secondary Outcome Measures

Full Information

First Posted
March 5, 2023
Last Updated
March 5, 2023
Sponsor
Shanghai Huihe Medical Technology Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05770635
Brief Title
Polyvinyl Alcohol Embolization Microspheres
Official Title
A Prospective, Multicenter, Randomized Controlled Trial to Evaluate the Safety and Efficacy of Polyvinyl Alcohol Embolization Microspheres for Transarterial Chemoembolization of Primary Liver Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
December 28, 2022 (Actual)
Primary Completion Date
December 28, 2024 (Anticipated)
Study Completion Date
December 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Huihe Medical Technology Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Liver Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
224 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Polyvinyl alcohol embolization microspheres (Huihe Medical) and chemotherapy drug
Arm Type
Experimental
Arm Description
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.
Arm Title
Embosphere and chemotherapy drug
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Embosphere and chemotherapy drug
Intervention Description
chemotherapeutic drug + embolic Embosphere;Iodide is selected according to the subject's condition
Intervention Type
Device
Intervention Name(s)
Polyvinyl alcohol embolization microspheres (Huihe Medical) and chemotherapy drug
Intervention Description
chemotherapy drug+Polyvinyl alcohol embolization microspheres (Huihe Medical);Iodide is selected according to the subject's condition
Primary Outcome Measure Information:
Title
Objective response rate (ORR) 1 month after the last TACE -mRECIST evaluation
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age≥18 years old; age ≤85 years old; regardless of gender 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; Child-Pugh A or B (less than 10 points); performance status (PS) score of ECOG 0~2; The patient had at least one measurable tumor lesion without embolization (maximum diameter of the target lesion ≤10cm); Those who agree to participate in the clinical trial and voluntarily sign the informed consent; Exclusion Criteria: 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; The proportion of tumor in total liver volume was ≥70%; Patients with distant extensive metastasis or other malignant tumors; The expected survival time is less than 3 months; Cachexia or multiple organ failure; Severe liver dysfunction (Child-Pugh grade C), including jaundice, hepatic encephalopathy, refractory ascites, or hepatorenal syndrome; 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; Renal dysfunction: patients with serum creatinine > 2mg/dL; Blood leukocytes and platelets decreased significantly, leukocytes < 3.0×109/L, platelets < 50×109/L (except patients with hyperplenism and chemotherapy myelosuppression); 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); Patients with active hepatitis or severe infection who cannot be treated with TACE simultaneously; Patients with complete obstruction of the main portal vein and unable to restore portal blood flow through compensatory collateral branches of the portal vein; 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.); Subjects who predicted that the target lesion would require more than three TAces; Uncontrolled diabetes mellitus; 15. 16. 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;
Facility Information:
Facility Name
Shanghai Huihe Healthcare Tecnology Co.,Ltd.
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201615
Country
China

12. IPD Sharing Statement

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Polyvinyl Alcohol Embolization Microspheres

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