Actively Recruiting
A Study of Yttrium [90Y] Microsphere Injection in Combination With Targeted Immunotherapy in the Treatment of HCC
Led by GrandPharma (China) Co., Ltd. · Updated on 2026-01-12
120
Participants Needed
3
Research Sites
122 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is A Randomized, Active-Controlled, Open-Label National Multicenter Phase 2 Registration Clinical Study of Yttrium \[90Y\] Microsphere Injection in Combination with Camrelizumab and/or Apatinib and Yttrium \[90Y\] Microsphere Injection Alone versus Conventional Transcatheter Arterial Chemoembolization (cTACE) in the Treatment of Unresectable or Non-Ablative, Non-Metastatic Hepatocellular Carcinoma (HCC). Its aim is to evaluate the efficacy and safety of yttrium \[90Y\] resin microsphere injection combined with Camrelizumab and/or apatinib compared with yttrium \[90Y\] resin microsphere injection alone in the treatment of inoperable or ablatable, non-metastatic HCC.
CONDITIONS
Official Title
A Study of Yttrium [90Y] Microsphere Injection in Combination With Targeted Immunotherapy in the Treatment of HCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years who voluntarily agree to participate and can comply with study procedures
- Confirmed hepatocellular carcinoma by pathology or clinical guidelines
- Not suitable for or refusing surgery or ablation treatments
- China Liver Cancer Clinical Staging (CNLC) Ib to IIIa without Vp4 portal vein tumor thrombus
- At least one measurable tumor lesion by RECIST v1.1 and mRECIST
- Evaluated as suitable for selective internal radiation therapy with yttrium [90Y] microspheres
- No contraindications to yttrium [90Y] microsphere injection, camrelizumab, apatinib, or cTACE
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Child-Pugh liver function class A or B with 7 points or less
- Life expectancy of at least 3 months
- If infected with HBV, receiving recommended antiviral treatment with controlled viral load
- If positive for HCV antibodies, negative for HCV RNA
- Normal organ and bone marrow function within specified laboratory limits
- Women of childbearing potential must use effective contraception during and for 3 months after treatment
You will not qualify if you...
- Other liver cancer types such as cholangiocarcinoma or fibrolamellar hepatocellular carcinoma
- Invasive HCC with diffuse microscopic tumor nodules
- Tumor burden over 50% of liver volume
- Tumor thrombus in hepatic vein, inferior vena cava, or beyond
- Other malignancies within 5 years except certain cured localized cancers
- Prior conversion therapies before hepatectomy
- Previous systemic anti-tumor treatments for HCC
- Recent use of Chinese medicines with anti-liver cancer effects
- Previous local liver cancer treatments except limited adjuvant TACE
- Prior organ or stem cell transplant except corneal
- Unresolved bile duct obstruction
- Severe liver dysfunction or decompensated cirrhosis
- Symptomatic pleural or pericardial effusion requiring drainage
- Allergy to iodine contrast or inability to undergo enhanced CT
- Gastrointestinal conditions affecting drug absorption
- Active tuberculosis or immune deficiencies
- Serious cardiovascular or cerebrovascular diseases
- History of lung diseases affecting treatment assessment
- Severe bleeding disorders or recent use of blood-thinning medications
- Recent participation in other clinical trials
- Active autoimmune diseases requiring systemic treatment
- High risk of bleeding or recent serious bleeding events
- Recent abdominal fistula, perforation, abscess, or intestinal obstruction
- Recent thromboembolic events
- Recent major surgery, trauma, or unhealed wounds
- Recent live vaccines or use of strong CYP3A4 modulators
- Recent immunosuppressive or immunomodulatory drug use
- Pregnant or breastfeeding women
- Other serious illnesses or lab abnormalities affecting treatment or safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Beijing Tsinghua Changgung Hospital
Beijing, China
Actively Recruiting
2
Nanjing Tianyinshan Hospital
Nanjin, China
Not Yet Recruiting
3
Zhongshan Hospital Fudan University
Shanghai, China
Actively Recruiting
Research Team
X
xixi hu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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