Clinical trial NCT06909708: SIRT Versus cTACE for Unresectable HCC (CHANCE2506)
Official title: SIRT (Yttrium-90 Carbon Microspheres) Versus cTACE for Unresectable Hepatocellular Carcinoma: A Multicenter, Prospective, Open-label, Phase 3 Trial (CHANCE2506)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Unresectable Hepatocellular Carcinoma
Keywords: HCC
TACE
Selective internal radiation therapy
Yttrium-90
Lead sponsor: Zhongda Hospital
Sponsor class: OTHER
First posted: 2025-04-03
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental Group : Yttrium-90 carbon microspheres. Control Group : Conventional transarterial chemoembolization (cTACE) using anti-tumor drug, lipiodol and embolic particles.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time to progression (TTP)
timeFrame: From enrollment to 54 weeks after the treatment
Secondary outcomes:
measure: Adverse events
timeFrame: From enrollment to 54 weeks after the treatment
measure: Severe adverse events
timeFrame: From the enrollment to 54 weeks after the treatment.
measure: localized time to progression
timeFrame: From the enrollment to 54 weeks after the treatment.
measure: Objective response rates (ORR)
timeFrame: From enrollment to 54 weeks after the treatment.
measure: Overall survival (OS)
timeFrame: From the enrollment to the death or lost to follow up.
measure: Duration of response (DoR)
timeFrame: From the enrollment to 54 weeks after the treatment
measure: Resection rate of liver target lesions
timeFrame: From enrollment to 54 weeks after the treatment.
measure: Tumor markers
timeFrame: From the enrollment to 54 weeks after the treatment.
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital, Southeast University
state: Jiangsu
Study officials:
affiliation: Zhongda Hospital, Soueast University
name: Gao-Jun Teng
role: PRINCIPAL_INVESTIGATOR
References: