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)

Overview

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.

Interventions

• Procedure SIRT
  Y-90 administered
• Procedure cTACE
  cTACE administered

Primary outcome measures

• Time to progression (TTP) [Time frame: From enrollment to 54 weeks after the treatment]

Secondary outcome measures (8)

• Adverse events [Time frame: From enrollment to 54 weeks after the treatment]
• Severe adverse events [Time frame: From the enrollment to 54 weeks after the treatment.]
• localized time to progression [Time frame: From the enrollment to 54 weeks after the treatment.]
• Objective response rates (ORR) [Time frame: From enrollment to 54 weeks after the treatment.]
• Overall survival (OS) [Time frame: From the enrollment to the death or lost to follow up.]
• Duration of response (DoR) [Time frame: From the enrollment to 54 weeks after the treatment]
• Resection rate of liver target lesions [Time frame: From enrollment to 54 weeks after the treatment.]
• Tumor markers [Time frame: From the enrollment to 54 weeks after the treatment.]

Eligibility criteria

Inclusion criteria

• Eastern Cooperative Oncology Group performance status ≤ 1;
• Expected survival time ≥ 3 months;
• Confirmed hepatocellular carcinoma based on CNLC guidelines;
• Without extrahepatic metastases, unresectable or refuse surgical resection;
• At least one well defined tumor (mRECIST 1.1);
• Tumor burden≤50% of the total liver volume;
• Child-Pugh score≤7;
• 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;
• 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

• With previous history of hepatic encephalopathy;
• Extrahepatic disease or combined with other malignant tumors;
• Infiltrative hepatocellular carcinoma ;
• With prior antitumor therapies, including liver transplantation, hepatectomy, ablation, TACE, chemotherapy, radiotherapy, targeted therapy or immunotherapy;
• With hepatic artery malformation and unable to undergo TACE or SIRT;
• Allergy to contrast agents or anesthetics
• With clinical manifestations of portal hypertension, moderate-severe or refractory ascites, or decompensated liver cirrhosis, or moderate-to-severe esophageal/gastric varices;
• 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);
• The single lung radiation absorbed dose>30 Gy;
• Tumor thrombus in main portal vein or hepatic artery or hepatic vein or bile duct;
• Serious infections in active stage or need systematic treatment;
• Pregnant and lactating women;
• With positive results of HIV antibody test;
• HBV DNA or HCV RNA positive;
• With active syphilis or tuberculosis;
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Zhongda Hospital, Southeast University — Nanjing

Identifiers

NCT: NCT06909708 · CHANCE2506-NRT6003

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗