Primary liver cancer
Conditions
Interventions
Experimental group:Polyvinyl alcohol embolization microspheres (Huihe Medical) and chemotherapy drug
Control group:Embosphere and chemotherapy drug
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-85 years; No gender limit; 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. Leukocyte and platelet decreased significantly, leukocyte < 3.0×10^9/L, platelet < 50×10^9/L (except for hyperplenism and chemotherapeutic 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. Patients who predicted that the target lesion would require more than three TACEs; 15. Uncontrolled diabetes; 16. Patients with known severe allergy to contrast agents, iodine contrast agents or embolic materials; 17. Pregnant/lactating patients, 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. Patients without the ability to make independent decisions or with mental illness; 20. Other patients deemed unsuitable for this clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR) 1 month after the last TACE -mRECIST evaluation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate of target lesion 1 month after the first TACE and 3 months after the last TACE;Disease control rate of target lesions 1 month after the first TACE, 1 month after the last TACE, and 3 months after the last TACE-mRECIST evaluation;Treatment effect (TE) on target lesions 1 month after the first TACE, 1 month after the last TACE, and 3 months after the last TACE;Success rate of embolization of target lesions;All-cause mortality;Tumor-related mortality;Alpha-fetoprotein (AFP) response rate;Overall survival (OS);Progression-free survival;Time to progression, TTP; | — |
Countries
China
Contacts
Public ContactYan Zhiping
Zhongshan Hospital, Fudan University
Outcome results
None listed