SIRT Versus cTACE for Unresectable HCC (CHANCE2506) (NRT6003)

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

To evaluate the efficacy and safety of yttrium-90 carbon microspheres versus cTACE in patients with unresectable hepatocellular carcinoma

Study Overview

• Status: Recruiting
• Conditions: Unresectable Hepatocellular Carcinoma
• Intervention / Treatment: Procedure: SIRT; Procedure: cTACE

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.

• Study Type: Interventional
• Enrollment (Estimated): 108
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hai-Dong Zhu; Phone Number: +86-25-83272121; Email: zhuhaidong9509@163.com
• Study Contact Backup: Name: Lei Zhang; Phone Number: +86-25-83272121; Email: llei589@126.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Recruiting
      • Zhongda Hospital, Southeast University
      • Contact: Hai-Dong Zhu; Email: zhuhaidong9509@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SIRT Group; Each Participant will underwent a single intra-arterial infusion of yttrium-90 carbon microspheres (NRT6003 injection)].	Procedure: SIRT; Y-90 administered; Other Names: Yttrium-90 [90Y]
Active Comparator: cTACE Group; Each Participant will underwent conventional transarterial chemoembolization (cTACE).	Procedure: cTACE; cTACE administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to progression (TTP)	Evaluated by the independent image review committee (CTCAE 5.0)	From enrollment to 54 weeks after the treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Rates and degree of adverse events	From enrollment to 54 weeks after the treatment
Severe adverse events	Rates of severe adverse events	From the enrollment to 54 weeks after the treatment.
localized time to progression	Localized time to progression evaluated by the investigator	From the enrollment to 54 weeks after the treatment.
Objective response rates (ORR)	Evaluated by the investigator	From enrollment to 54 weeks after the treatment.
Overall survival (OS)	Overall survival	From the enrollment to the death or lost to follow up.
Duration of response (DoR)	Evaluated by the investigator	From the enrollment to 54 weeks after the treatment
Resection rate of liver target lesions	Resection rate of liver target lesions	From enrollment to 54 weeks after the treatment.
Tumor markers	The variation of tumor markers	From the enrollment to 54 weeks after the treatment.

Collaborators and Investigators

• Sponsor: Zhongda Hospital
• Investigators: Principal Investigator: Gao-Jun Teng, Zhongda Hospital, Soueast University

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 30, 2027

Study Registration Dates

• First Submitted: March 26, 2025
• First Submitted That Met QC Criteria: March 26, 2025
• First Posted (Actual): April 3, 2025

Study Record Updates

• Last Update Posted (Actual): April 9, 2025
• Last Update Submitted That Met QC Criteria: April 6, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: HCC; TACE; Yttrium-90; Selective internal radiation therapy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: CHANCE2506-NRT6003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No