Unresectable Hepatocellular Carcinoma
Conditions
Keywords
HCC, TACE, Selective internal radiation therapy, Yttrium-90
Brief summary
To evaluate the efficacy and safety of yttrium-90 carbon microspheres versus cTACE in patients with unresectable hepatocellular carcinoma
Detailed description
The efficacy and safety of yttrium-90 carbon microspheres versus in patients with unresectable hepatocellular carcinoma (HCC) remain unknown. This multicenter, prospective, open-label, phase 3 trial is designed to evaluate the safety and efficacy of yttrium-90 carbon microspheres versus conventional TACE in patients with hepatocellular carcinoma. The primary endpoint is time to progression for patients with HCC. While the secondary endpoints include the overall response rate, duration of response, local time to progression, tumor biomarkers variation, overall survival and adverse events.
Sponsors
Zhongda Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Experimental Group : Yttrium-90 carbon microspheres. Control Group : Conventional transarterial chemoembolization (cTACE) using anti-tumor drug, lipiodol and embolic particles.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Eastern Cooperative Oncology Group performance status ≤ 1; 2. Expected survival time ≥ 3 months; 3. Confirmed hepatocellular carcinoma based on CNLC guidelines; 4. Without extrahepatic metastases, unresectable or refuse surgical resection; 5. At least one well defined tumor (mRECIST 1.1); 6. Tumor burden≤50% of the total liver volume; 7. Child-Pugh score≤7; 8. Adequate organ function: # Blood routine: absolute neutrophil count ≥ 1.5×10\^9/L; platelet≥75×10\^9/L; hemoglobin≥90 g/L; # Liver function: total bilirubin≤2 times upper limit of normal (ULN); alanine transaminase and aspartate aminotransferase≤5.0 ULN; alkaline phosphatase≤2.5 ULN; Albumin\>30 g/L; # Renal function: Cr≤1.5 ULN; creatinine clearance≥50 mL/min; # Coagulation function: international normalized ratio, prothrombin time and activated partial thromboplastin time were less than 1.5 ULN; 9. Women and men of childbearing age must agree to take strict and effective contraceptive measures during the study period and within 6 m after the end of the trial.
Exclusion criteria
1. With previous history of hepatic encephalopathy; 2. Extrahepatic disease or combined with other malignant tumors; 3. Infiltrative hepatocellular carcinoma ; 4. With prior antitumor therapies, including liver transplantation, hepatectomy, ablation, TACE, chemotherapy, radiotherapy, targeted therapy or immunotherapy; 5. With hepatic artery malformation and unable to undergo TACE or SIRT; 6. Allergy to contrast agents or anesthetics 7. With clinical manifestations of portal hypertension, moderate-severe or refractory ascites, or decompensated liver cirrhosis, or moderate-to-severe esophageal/gastric varices; 8. With severe pulmonary insufficiency (forced expiratory volume at one second / forced vital capacity\<50% or forced expiratory volume at one second /predicting value\<50% or maximum volume per minute\<50 L/min); 9. The single lung radiation absorbed dose\>30 Gy; 10. Tumor thrombus in main portal vein or hepatic artery or hepatic vein or bile duct; 11. Serious infections in active stage or need systematic treatment; 12. Pregnant and lactating women; 13. With positive results of HIV antibody test; 14. HBV DNA or HCV RNA positive; 15. With active syphilis or tuberculosis; 16. 99mTc-MAA imaging (patients exclusion meet all criteria): 1\) Perfusion area covers all intrahepatic tumors (including non-target lesions) and non-perfused liver volume ≥30% of total liver volume; 2) Tumor dose ≥400 Gy for 1-2 hepatic segments; Perfused normal liver dose (PNLD): 120 Gy \< PNLD \<1000 Gy; Tumor dose ≥200 Gy (recommended ≥400 Gy) and PNLD \<120 Gy with other condition; 3) No gastrointestinal shunt , or shunt amendment by endovascular techniques (reassessment required); 4) cTACE should cover all intrahepatic lesions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to progression (TTP) | From enrollment to 54 weeks after the treatment | Evaluated by the independent image review committee (CTCAE 5.0) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severe adverse events | From the enrollment to 54 weeks after the treatment. | Rates of severe adverse events |
| localized time to progression | From the enrollment to 54 weeks after the treatment. | Localized time to progression evaluated by the investigator |
| Objective response rates (ORR) | From enrollment to 54 weeks after the treatment. | Evaluated by the investigator |
| Adverse events | From enrollment to 54 weeks after the treatment | Rates and degree of adverse events |
| Duration of response (DoR) | From the enrollment to 54 weeks after the treatment | Evaluated by the investigator |
| Resection rate of liver target lesions | From enrollment to 54 weeks after the treatment. | Resection rate of liver target lesions |
| Tumor markers | From the enrollment to 54 weeks after the treatment. | The variation of tumor markers |
| Overall survival (OS) | From the enrollment to the death or lost to follow up. | Overall survival |
Countries
China
Contacts
Primary ContactHai-Dong Zhu
Backup ContactLei Zhang
Outcome results
None listed