Actively Recruiting
A Multicenter Clinical Study of Combined Therapy for Unresectable Hepatocellular Carcinoma
Led by West China Hospital · Updated on 2026-03-19
33
Participants Needed
1
Research Sites
125 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial was designed to evaluate the safety and efficacy of Y90-SIRT combined with nivolumab, ipilimumab, and lenvatinib in patients with unresectable HCC. In addition to assessing short-term efficacy endpoints, such as ORR and PFS, this trial places particular emphasis on the OS benefit for patients. This study is therefore both novel and innovative.
CONDITIONS
Official Title
A Multicenter Clinical Study of Combined Therapy for Unresectable Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed unresectable hepatocellular carcinoma by imaging or histology, or refusal of surgery
- Eligible for yttrium-90 selective internal radiation therapy with no evidence of disease outside the liver except lymph nodes
- Age between 18 and 80 years at enrollment
- Child-Pugh class A liver function
- ECOG performance status of 0 or 1
- Lung dose threshold for yttrium-90 microspheres \u2264 30 Gy and expected future liver remnant volume \u2265 30% of total liver volume
- One or more measurable lesions; if portal vein invasion, disease confined to one liver lobe suitable for treatment
- If co-infected with hepatitis B or C, viral levels must be monitored and meet specified criteria
- No prior systemic therapy or transarterial radioembolization with yttrium-90 glass microspheres
- No active or history of chronic/recurrent autoimmune disease
- Adequate blood counts, liver and kidney function meeting specified laboratory values
- Not pregnant and no intention to conceive during treatment
- Written informed consent provided
- Expected survival of at least 12 weeks
You will not qualify if you...
- Diffuse hepatocellular carcinoma or vascular invasion or spread outside the liver, except segmental portal or hepatic vein invasion
- Child-Pugh class C cirrhosis
- Contraindications to hepatic arterial embolization including coagulopathy or severe arteriosclerosis
- Significant heart disease including congestive heart failure above NYHA class II or uncontrolled arrhythmias
- Recent thrombotic or embolic events within 6 months except segmental portal vein thrombosis
- Use of systemic anticancer therapy or investigational drugs within 4 weeks before study
- Use of immunosuppressive drugs within 28 days before starting nivolumab or ipilimumab, with some exceptions
- Receipt of live attenuated vaccines within 30 days before study drug
- Major surgery within 4 weeks before study and not fully recovered
- Second primary cancer unless disease-free over 3 years, except certain skin or cervical cancers
- Uncontrolled infections or comorbidities that increase risk or limit study compliance
- Active infections including positive hepatitis B surface antigen or hepatitis C RNA
- History of organ transplantation
- Psychiatric or mental conditions interfering with consent or compliance
- Symptomatic brain metastases
- Pregnant or breastfeeding women
- Immunocompromised including HIV infection
- Active or prior documented autoimmune or inflammatory diseases
- Known allergy to study drugs or components
- Prior participation in investigational drug or device studies within 4 weeks before treatment initiation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Study Chair Liu Chang , West China Hospital
Chengdu, Sichuan, China, 610041
Actively Recruiting
Research Team
C
Chang Liu, 医生
CONTACT
R
Ruihong Dai, 医生
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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