Clinical Trials Logo

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05770635
Other study ID # CSP-V-01
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date December 28, 2022
Est. completion date December 28, 2024

Study information

Verified date March 2023
Source Shanghai Huihe Medical Technology Co., Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 method


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 224
Est. completion date December 28, 2024
Est. primary completion date December 28, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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: 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. 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;

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Embosphere and chemotherapy drug
chemotherapeutic drug + embolic Embosphere;Iodide is selected according to the subject's condition
Polyvinyl 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

Locations

Country Name City State
China Shanghai Huihe Healthcare Tecnology Co.,Ltd. Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Huihe Medical Technology Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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: 1 month after the last TACE -mRECIST evaluation
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03161925 - Chinese Liver Cancer Clinical Survey N/A
Completed NCT00261378 - Prospective Randomised Study of Doxorubicin in the Treatment of Hepatocellular Carcinoma by Drug-Eluting Bead Embolisation Phase 2
Enrolling by invitation NCT05609448 - MRI-guided Holmium-166 Radioembolization N/A
Recruiting NCT05714124 - Liver Embolization Approaches for Tumor Management
Not yet recruiting NCT05353894 - Effect of Food and Formulation on the Pharmacokinetics, Safety, and Tolerability of GNS561 After One Single Dose (50 and 200mg) in Healthy Volunteers Phase 1
Completed NCT03518632 - Preoperative Physical Activity Intervention in Patients Before Planned Liver Resection for Cancer (APACHE) N/A
Terminated NCT00003530 - Antineoplaston Therapy in Treating Patients With Primary Liver Cancer Phase 2
Recruiting NCT04806464 - Clinical Study of VG161 in Subjects With Advanced Primary Liver Cancer Phase 1
Recruiting NCT06342414 - An Exosome-Based Liquid Biopsy for the Differential Diagnosis of Primary Liver Cancer
Completed NCT01116804 - Role PET Imaging in Response Assessment for Hepatocellular Carcinoma (HCC) Phase 1
Recruiting NCT03067493 - RFA or Surgical Resection Combined With Neo-MASCT for Primary HCC: a Phase II Trial Phase 2
Completed NCT05183776 - Clinical Validation of a Fractional Administration Device for Holmium-166 SIRT N/A
Not yet recruiting NCT06430983 - Recurrent Liver Cancer: Reconceptualization and Reevaluation
Recruiting NCT05677724 - Single-cell RNA Sequencing Resolves the Regulatory Role of HBV on the Hepatocellular Carcinoma Immune Microenvironment
Not yet recruiting NCT03178929 - Effect of SAMe Treatment on Recurrence After Radical Treatment of Primary Hepatic Carcinoma N/A
Recruiting NCT05267080 - Registry on Percutaneous Electrochemotherapy
Not yet recruiting NCT02327819 - The Effect of Branched-chain Amino Acid (BCAA) on the Progression of Primary Liver Cancer N/A
Completed NCT01640522 - Comprehensive Electronic Cancer Support System for the Treatment of Cancer Related Symptoms N/A
Completed NCT00408122 - Evaluation of Preoperative Investigations in Patients With Liver Cancer N/A
Recruiting NCT03297255 - Primary Liver Cancer Cohort of South China N/A