Comparing two treatments for advanced liver cancer

SIRT (Yttrium-90 Carbon Microspheres) Versus cTACE for Unresectable Hepatocellular Carcinoma: A Multicenter, Prospective, Open-label, Phase 3 Trial (CHANCE2506)

This study is testing whether a new treatment using yttrium-90 carbon microspheres works better than the standard chemoembolization for people with advanced liver cancer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 108 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Zhongda Hospital (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06909708 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of yttrium-90 carbon microspheres compared to conventional transarterial chemoembolization (cTACE) in patients with unresectable hepatocellular carcinoma (HCC). It is a multicenter, prospective, open-label trial designed to determine the primary endpoint of time to progression for patients with HCC. Secondary endpoints include overall response rate, duration of response, local time to progression, tumor biomarker variation, overall survival, and adverse events. The study aims to provide insights into which treatment may offer better outcomes for patients with this challenging condition.

Who should consider this trial

Good fit: Ideal candidates include patients with confirmed unresectable hepatocellular carcinoma who meet specific health criteria and have a performance status of 1 or lower.

Not a fit: Patients with extrahepatic metastases or those who are not candidates for either treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could provide a more effective treatment option for patients with unresectable hepatocellular carcinoma.

How similar studies have performed: Previous studies have shown promise in using yttrium-90 for liver cancer treatment, suggesting potential success for this approach.

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.

Where this trial is running

Nanjing, Jiangsu

• Zhongda Hospital, Southeast University — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Principal investigator: Gao-Jun Teng — Zhongda Hospital, Soueast University
• Study coordinator: Hai-Dong Zhu

Conditions Unresectable Hepatocellular Carcinoma; HCC; TACE; Selective internal radiation therapy; Yttrium-90