Actively Recruiting
Yttrium-90 Microspheres Compared to Conventional TACE for Unresectable Liver Cancer A Multicenter, Prospective Trial Evaluating Safety and Effectiveness
Led by Zhongda Hospital · Updated on 2025-04-09
108
Participants Needed
1
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of yttrium-90 carbon microspheres compared to conventional transarterial chemoembolization (cTACE) in patients with unresectable hepatocellular carcinoma (HCC), a type of liver cancer that cannot be removed by surgery. This multicenter, prospective, open-label phase 3 trial aims to determine which treatment better delays cancer progression. The primary goal is to measure the time until the cancer worsens, while secondary goals include response rates, duration of response, tumor marker changes, overall survival, and monitoring of side effects. Participants will receive one of two procedures: selective internal radiation therapy (SIRT) using yttrium-90 carbon microspheres or conventional TACE. Both treatments target liver tumors by delivering therapy directly to the tumor site. The trial is designed to compare these two approaches in a controlled setting to assess their relative safety and effectiveness for patients with unresectable HCC. During the study, participants will be followed from enrollment through 54 weeks after treatment to monitor disease progression and other outcomes. Researchers will conduct various assessments including tumor response evaluations, biomarker testing, and safety monitoring. This comprehensive follow-up aims to gather detailed information about how each treatment affects tumor growth, patient survival, and any adverse effects experienced over time.
CONDITIONS
Official Title
SIRT Versus cTACE for Unresectable HCC (CHANCE2506)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Expected survival time of at least 3 months
- Confirmed hepatocellular carcinoma based on CNLC guidelines
- No extrahepatic metastases, tumor unresectable or patient refuses surgical resection
- At least one well-defined tumor measurable by mRECIST 1.1 criteria
- Tumor burden 50% or less of total liver volume
- Child-Pugh score of 7 or less
- Adequate organ function, including blood counts, liver and kidney function, and coagulation within specified limits
- Women and men of childbearing age agree to use effective contraception during the study and for 6 months after
You will not qualify if you...
- History of hepatic encephalopathy
- Presence of extrahepatic disease or other malignant tumors
- Infiltrative hepatocellular carcinoma
- Previous antitumor therapies such as liver transplantation, hepatectomy, ablation, TACE, chemotherapy, radiotherapy, targeted therapy, or immunotherapy
- Hepatic artery malformation preventing TACE or SIRT
- Allergy to contrast agents or anesthetics
- Clinical signs of portal hypertension, moderate to severe or refractory ascites, decompensated liver cirrhosis, or moderate to severe esophageal/gastric varices
- Severe pulmonary insufficiency as defined by specific lung function measurements
- Radiation absorbed dose to single lung over 30 Gy
- Tumor thrombus in major liver vessels or bile duct
- Serious active infections requiring systemic treatment
- Pregnant or breastfeeding women
- Positive HIV antibody test
- Positive HBV DNA or HCV RNA test
- Active syphilis or tuberculosis
- Specific exclusion criteria based on 99mTc-MAA imaging and tumor dosing requirements for SIRT or cTACE
AI-Screening
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Trial Site Locations
Total: 1 location
1
Zhongda Hospital, Southeast University
Nanjing, Jiangsu, China, 210009
Actively Recruiting
Research Team
H
Hai-Dong Zhu
L
Lei Zhang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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