A Study of Yttrium [90Y] Microsphere Injection in Combination With Targeted Immunotherapy in the Treatment of HCC

NCT07334483 | Recruiting Phase 2 DMC

• 1 other identifier: ST561-1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

Brief Summary

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

HCC

Keywords

Yttrium [90Y] Microsphere Injection

Outcome Measures

Primary Outcomes (1)

• ORR

  Objective Response Rate, assessed by blinded independent central review (BICR) based on mRECIST criteria

  up to 18 months

Secondary Outcomes (11)

• PFS

  up to 18 months

• ORR

  up to 18 months

• hPFS

  up to 18 months

• hORR

  up to 18 months

• PFS rate

  up to 9 months

Study Arms (4)

Group A

EXPERIMENTAL

Yttrium \[90Y\] microsphere injection selective internal radiation therapy (SIRT) + camrelizumab + apatinib

Drug: Yttrium [90Y] Microsphere Injection; Drug: Camrelizumab; Drug: Apatinib

Group B

EXPERIMENTAL

Yttrium \[90Y\] microsphere injection SIRT + camrelizumab

Drug: Yttrium [90Y] Microsphere Injection; Drug: Camrelizumab

Group C

EXPERIMENTAL

Yttrium \[90Y\] microsphere injection SIRT

Drug: Yttrium [90Y] Microsphere Injection

Group D

ACTIVE COMPARATOR

Conventional transcatheter arterial chemoembolization

Other: Conventional transcatheter arterial chemoembolization

Interventions

Yttrium [90Y] Microsphere Injection DRUG

Yttrium \[90Y\] microsphere injection should be implanted through the hepatic artery based on 99mTc-MAA SPECT/CT simulated surgery (Mapping) to evaluate the distribution of microsphere in the body, and calculate the activity required for treatment

Also known as: Yttrium-90 resin microsphere

Group A; Group B; Group C

Conventional transcatheter arterial chemoembolization OTHER

For the operation method of cTACE, please refer to the Clinical Practice Guidelines for Transcatheter Arterial Chemoembolization (TACE) Treatment of Hepatocellular Carcinoma in China (2023 Edition) and its related standard operating procedures (SOPs).

Also known as: cTACE

Group D

Camrelizumab DRUG

The first dose of Cycle 1 should be completed within 3 days after randomization. After Cycle 1 Day 1 (C1D1), it should be dosed every 3 weeks ± 3 days. Dosing may be delayed due to holidays, but should not exceed 7 days

Also known as: CAM

Group A; Group B

Apatinib DRUG

Apatinib will be used from Cycle 2 Day 1 (C2D1). Apatinib should be discontinued for at least 7 days before and after treatment with yttrium \[90Y\] microsphere injection

Also known as: RIVO

Group A

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who voluntarily participate in this study, sign the informed consent form (ICF), and are able to comply with the diagnosis, treatment, observation, follow-up visit and related procedures specified in this protocol, with good compliance.
• Patients aged ≥ 18 and ≤ 75, regardless of gender.
• HCC confirmed by pathological histology/cytology, or meeting the clinical diagnostic criteria in the Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2024 Edition) established by the National Health Commission.
• Patients who are not suitable for surgery (including hepatectomy and liver transplantation) or ablation treatment based on the judgment of investigator or clinical practice guidelines, or refuse surgery or ablation treatment.
• China Liver Cancer Clinical Staging (CNLC): Ib-IIIa. Vp4 portal vein tumor thrombus invasion will be excluded, if combined with Vp1-3 portal vein tumor thrombus, the tumor thrombus must be located on the same side of the liver lobe as the targeted tumor area.
• Patients with at least 1 measurable lesion according to RECIST v1.1 and mRECIST criteria.
• Patients who have been evaluated by Yttrium \[90Y\] Microsphere Injection Selective Internal Radiation Therapy and Dose Evaluation Committee as suitable for SIRT treatment.
• For yttrium \[90Y\] microsphere injection, camrelizumab and apatinib, there are no contraindications for use in the product instructions and clinical practice guidelines. Patients who are suitable for cTACE treatment, have no contraindications to use in clinical practice guidelines, are expected to be able to use up to 4 cTACE treatments for localized liver lesions within 24 weeks during the study period, and are expected to receive 1-2 cTACE treatments for a single lesion.
• ECOG PS score: 0-1.
• Child-Pugh liver function classification: Class A or Class B with ≤7 points.
• Life expectancy ≥3 months.
• If the subject has HBV or HCV infection, the following criteria must be met:
• i. Subjects with HBV infection (HBsAg and/or HBV-DNA positive): Subjects should receive antiviral treatment with one of the 4 drugs recommended by the national clinical guidelines for hepatitis B (tenofovir disoproxil fumarate, tenofovir alafenamide fumarate, tenofovir amibufenamide and entecavir) for at least 7 days before the first study treatment to achieve HBV-DNA \< 2000 IU/mL or \< 104 copies/mL. The standardized antiviral treatment must be received throughout the study.
• ii. If HCV-Ab is positive, the blood HCV RNA must be negative.
• Patients who have basically normal organ and bone marrow functions:

You may not qualify if:

• Cholangiocarcinoma, combined hepatocellular-cholangiocarcinoma, sarcomatoid hepatocellular carcinoma and fibrolamellar hepatocellular carcinoma confirmed by pathological histology or cytology.
• Invasive HCC, that is, imaging shows that microscopic or small tumor nodules are diffusely distributed in a certain liver lobe or the entire liver.
• Based on liver volume, the tumor burden is relatively large (\>50%).
• Presence of hepatic vein or inferior vena cava tumor thrombus, or involvement of the superior mesenteric vein or more distant end.
• Patients with other malignant tumors other than HCC within 5 years or at the same time. However, patients with cured localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, prostate cancer in situ, cervical cancer in situ and breast cancer in situ can be enrolled.
• Conversion therapies such as interventional and targeted immunotherapy have been used before hepatectomy, including conversion of functional residual liver volume (using ALPPS or PVE) and oncology conversion therapy.
• Previous systemic anti-tumor treatment for HCC, including molecular targeted drugs, systemic chemotherapy and immunotherapy (immune checkpoint inhibitors, antibody-drug conjugate \[ADC\], immune cells, oncolytic viruses and tumor vaccines, etc.).
• Use of Chinese patent medicines and modern Chinese medicine preparations with anti-liver cancer indications within 7 days before randomization.
• Previous local treatment for liver lesions, including TACE, transarterial embolization (TAE), hepatic artery infusion chemotherapy (HAIC), radiotherapy, or ablation of target liver lesions, injection of oncolytic viruses, and internal/external radiation therapy. In the case of adjuvant therapy after radical resection, patients who have only received one TACE can be enrolled.
• Previous solid organ (such as liver transplantation) or allogeneic stem cell transplantation (except for patients who have only received corneal transplantation).
• Patients with bile duct obstruction due to any reason that has not been resolved before randomization.
• Patients with decompensated cirrhosis and severe liver function impairment (Child-Pugh Grade C) before randomization, including severe jaundice, hepatic encephalopathy, hepatorenal syndrome or refractory ascites (i.e. clinically symptomatic moderate or severe ascites requiring therapeutic puncture, drainage or Child-Pugh ascites score \> 2).
• Patients with clinically symptomatic pleural effusion and pericardial effusion requiring puncture and drainage before randomization. However, patients who have received puncture and drainage within 2 weeks before enrollment and only show a small amount of effusion on imaging without clinical symptoms can be enrolled.
• History of iodine contrast agent allergy of grade II or above, or inability to undergo enhanced liver CT scan due to any reason.
• Patients who are unable to swallow the drug, have malabsorption syndrome, incomplete gastrointestinal obstruction or any condition that significantly affects the gastrointestinal absorption of apatinib mesylate before randomization.

Sponsors & Collaborators

• GrandPharma (China) Co., Ltd.: lead

Study Sites (3)

Beijing Tsinghua Changgung Hospital

Beijing, China

RECRUITING

Nanjing Tianyinshan Hospital

Nanjin, China

NOT YET RECRUITING

Zhongshan Hospital Fudan University

Shanghai, China

RECRUITING

MeSH Terms

Interventions

Yttrium; Yttrium-90; Microspheres; camrelizumab; apatinib

Intervention Hierarchy (Ancestors)

Metals, Rare Earth; Elements; Inorganic Chemicals; Transition Elements; Metals; Equipment and Supplies

Study Officials

• Zhiping Yan, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

xixi hu

CONTACT

027-84399665; huxx@grandpharma.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2025
• First Posted: January 12, 2026
• Study Start: August 22, 2025
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: January 12, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)