Actively Recruiting
Randomized Study of Yttrium [90Y] Microsphere Injection With Camrelizumab and/or Apatinib Versus cTACE in Treating Hepatocellular Carcinoma
Led by GrandPharma (China) Co., Ltd. · Updated on 2026-01-12
120
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating treatments for people with hepatocellular carcinoma (HCC) that cannot be removed by surgery or treated with ablation and has not spread to other parts of the body. This Phase 2 study compares the effects and safety of yttrium [90Y] microsphere injection combined with immunotherapy drugs camrelizumab and/or apatinib, versus yttrium [90Y] microsphere injection alone and the conventional transcatheter arterial chemoembolization (cTACE) procedure. The goal is to find out how well these treatments work and their safety profiles in this patient group. Participants will be randomly assigned to one of four groups: yttrium [90Y] microsphere injection plus camrelizumab and apatinib; yttrium [90Y] microsphere injection plus camrelizumab; yttrium [90Y] microsphere injection alone; or cTACE. Yttrium [90Y] microspheres are delivered through the hepatic artery based on a mapping procedure, while camrelizumab is given every three weeks starting shortly after randomization. Apatinib treatment begins after the first cycle and is paused around the yttrium [90Y] injection. Treatments continue until withdrawal criteria are met, with yttrium [90Y] and immunotherapies given for up to 18 months. During the study, participants will undergo regular assessments including imaging to measure tumor response and progression-free survival up to 18 months. Safety, overall survival, and other measures such as duration of response and disease control rate are also evaluated. The study involves multiple visits for treatment, monitoring, and follow-up to track how participants respond and to observe any side effects over time.
CONDITIONS
Brief 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...
- Patients aged 18 to 75 years, any gender
- Confirmed hepatocellular carcinoma (HCC) by pathology or clinical criteria
- Not suitable for surgery or ablation, or refuse these treatments
- China Liver Cancer Clinical Staging (CNLC) Ib-IIIa
- At least one measurable tumor lesion
- Suitable for yttrium [90Y] microsphere injection treatment
- No contraindications to study drugs or cTACE treatment
- ECOG performance status 0-1
- Child-Pugh liver function class A or B with score 3
- Life expectancy at least 3 months
- Controlled HBV or HCV infection according to protocol
- Normal organ and bone marrow functions as defined by lab tests
- Effective contraception for patients of childbearing potential
You will not qualify if you...
- Other liver cancer types such as cholangiocarcinoma or fibrolamellar carcinoma
- Diffuse invasive HCC or tumor burden over 50% liver volume
- Tumor thrombus in hepatic vein, inferior vena cava, or distant veins
- Other active malignancies within 5 years except certain cured localized tumors
- Prior systemic anti-tumor treatment for HCC
- Previous local liver treatments like TACE, radiotherapy, or ablation except limited adjuvant TACE
- Organ or stem cell transplantation other than corneal
- Unresolved bile duct obstruction
- Decompensated cirrhosis or severe liver impairment
- Significant pleural or pericardial effusion needing drainage
- Allergy to iodine contrast or inability to undergo enhanced CT
- Severe gastrointestinal conditions affecting drug absorption
- Active infections including tuberculosis, HIV, syphilis, or co-infections
- Severe cardiovascular or cerebrovascular disease
- History of lung disease affecting immune or radiation therapy
- Bleeding disorders or recent use of blood-thinning medications
- Participation in other clinical trials with investigational drugs within 30 days
- Active autoimmune diseases requiring systemic treatment
- Pregnancy or breastfeeding
- Other serious diseases or lab abnormalities judged unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 18 months
Participants receive yttrium [90Y] microsphere injection alone or in combination with camrelizumab and/or apatinib, or conventional transcatheter arterial chemoembolization (cTACE) to treat hepatocellular carcinoma. Treatments continue until criteria for withdrawal are met, for up to 18 months.
Repeated treatment visits with dosing every 3 weeks for camrelizumab and cycles for apatinib as scheduled; yttrium [90Y] microsphere injection or cTACE procedures as per protocol
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
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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