Primary Liver CancerNCT05770635
Polyvinyl Alcohol Embolization Microspheres
A study testing Embosphere and chemotherapy drug and Polyvinyl alcohol embolization microspheres (Huihe Medical) and chemotherapy drug in people with Primary Liver Cancer, run by Shanghai Huihe Medical Technology Co., Ltd at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Primary Liver Cancer
- What is being tested?
- Embosphere and chemotherapy drug and Polyvinyl alcohol embolization microspheres (Huihe Medical) and chemotherapy drug
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteChina
- Study dates
- 28 Dec 2022to 28 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
Show all 15Show fewer
- 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;
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Huihe Healthcare Tecnology Co.,Ltd.
Shanghai, Shanghai Municipality, 201615
About this study
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
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
- Conditions
- Primary Liver Cancer
- Being tested
- Embosphere and chemotherapy drug, Polyvinyl alcohol embolization microspheres (Huihe Medical) and chemotherapy drug
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Embosphere and chemotherapy drugDevice
chemotherapeutic drug + embolic Embosphere;Iodide is selected according to the subject's condition
Polyvinyl alcohol embolization microspheres (Huihe Medical) and chemotherapy drugDevice
chemotherapy drug+Polyvinyl alcohol embolization microspheres (Huihe Medical);Iodide is selected according to the subject's condition
| Study group | Role | What they receive |
|---|---|---|
| Polyvinyl alcohol embolization microspheres (Huihe Medical) and chemotherapy drug | Experimental | 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. Receives: Device: Polyvinyl alcohol embolization microspheres (Huihe Medical) and chemotherapy drug |
| Embosphere and chemotherapy drug | Other | Not described Receives: Device: Embosphere and chemotherapy drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
Measured: 1 month after the last TACE -mRECIST evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start28 Dec 2022
- Primary completion28 Dec 2024 (estimated)
- Study completion28 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Liver CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Huihe Medical Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05770635
- Sponsor's protocol ID
- CSP-V-01
- Status last verified
- Mar 2023
- First submitted
- 5 Mar 2023
- Last updated
- 15 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05770635
- Acronym / sponsor ID
- CSP-V-01
- Conditions
- Primary Liver Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- Shanghai Huihe Medical Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 28 Dec 2022 (actual)
- Primary completion
- 28 Dec 2024 (estimated)
- Study completion
- 28 Dec 2024 (estimated)
- First posted
- 15 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polyvinyl alcohol embolization microspheres (Huihe Medical) and chemotherapy drug | Experimental | Device: Polyvinyl alcohol embolization microspheres (Huihe Medical) and chemotherapy drugThe 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. |
| Embosphere and chemotherapy drug | Other | Device: Embosphere and chemotherapy drug |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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);
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Embosphere and chemotherapy drugchemotherapeutic drug + embolic Embosphere;Iodide is selected according to the subject's condition | Device | Embosphere and chemotherapy drug |
| Polyvinyl alcohol embolization microspheres (Huihe Medical) and chemotherapy drugchemotherapy drug+Polyvinyl alcohol embolization microspheres (Huihe Medical);Iodide is selected according to the subject's condition | Device | Polyvinyl alcohol embolization microspheres (Huihe Medical) and chemotherapy drug |
Primary outcome
Objective response rate (ORR) 1 month after the last TACE -mRECIST evaluation
Time frame: 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:
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Embosphere and chemotherapy drug and Polyvinyl alcohol embolization microspheres (Huihe Medical) and chemotherapy drug in people with Primary Liver Cancer, run by Shanghai Huihe Medical Technology Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) 1 month after the last TACE -mRECIST evaluation (time frame: 1 month after the last TACE -mRECIST evaluation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2023.