SIRT Versus cTACE for Unresectable HCC (CHANCE2506)

NCT06909708 | Recruiting DMC

• 1 other identifier: CHANCE2506-NRT6003
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Unresectable Hepatocellular Carcinoma

Keywords

HCC; TACE; Selective internal radiation therapy; Yttrium-90

Outcome Measures

Primary Outcomes (1)

• Time to progression (TTP)

  Evaluated by the independent image review committee (CTCAE 5.0)

  From enrollment to 54 weeks after the treatment

Secondary Outcomes (8)

• Adverse events

  From enrollment to 54 weeks after the treatment

• Severe adverse events

  From the enrollment to 54 weeks after the treatment.

• localized time to progression

  From the enrollment to 54 weeks after the treatment.

• Objective response rates (ORR)

  From enrollment to 54 weeks after the treatment.

• Overall survival (OS)

  From the enrollment to the death or lost to follow up.

Study Arms (2)

SIRT Group

EXPERIMENTAL

Each Participant will underwent a single intra-arterial infusion of yttrium-90 carbon microspheres (NRT6003 injection)\].

Procedure: SIRT

cTACE Group

ACTIVE COMPARATOR

Each Participant will underwent conventional transarterial chemoembolization (cTACE).

Procedure: cTACE

Interventions

SIRT PROCEDURE

Y-90 administered

Also known as: Yttrium-90 [90Y]

SIRT Group

cTACE PROCEDURE

cTACE administered

cTACE Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Zhongda Hospital: lead

Study Sites (1)

Zhongda Hospital, Southeast University

Nanjing, Jiangsu, 210009, China

RECRUITING

MeSH Terms

Interventions

Sirtuins; Yttrium-90

Intervention Hierarchy (Ancestors)

Group III Histone Deacetylases; Histone Deacetylases; Amidohydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; ADP Ribose Transferases; Pentosyltransferases; Glycosyltransferases; Transferases; Intracellular Signaling Peptides and Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Gao-Jun Teng

  Zhongda Hospital, Soueast University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hai-Dong Zhu

CONTACT

+86-25-83272121; zhuhaidong9509@163.com

Lei Zhang

CONTACT

+86-25-83272121; llei589@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Interventional and Vascular Surgery Department

Model Details: Experimental Group : Yttrium-90 carbon microspheres. Control Group : Conventional transarterial chemoembolization (cTACE) using anti-tumor drug, lipiodol and embolic particles.

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 3, 2025
• Study Start: April 3, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)