NCT07334483

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

A Randomized, Active-Controlled, Open-Label Study of Yttrium [90Y] Microsphere Injection in Combination With Camrelizumab and/or Apatinib and Yttrium [90Y] Microsphere Injection Alone Versus cTACE in the Treatment of HCC

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: GrandPharma (China) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, randomized, active-controlled, open-label, multicenter Phase 2 clinical study to evaluate the efficacy and safety of yttrium \[90Y\] microsphere injection in combination with camrelizumab and/or apatinib and yttrium \[90Y\] microsphere injection alone versus cTACE in the treatment of unresectable or non-ablative, non-metastatic HCC. A total of at least 120 subjects with unresectable or non-ablative, non-metastatic HCC are planned to be enrolled and randomly assigned to groups A, B, C and D in a 1:1:1:1 ratio, that is, yttrium \[90Y\] microsphere injection + camrelizumab + apatinib group (A), yttrium \[90Y\] microsphere injection + camrelizumab group (B), yttrium \[90Y\] microsphere injection group (C) and cTACE group (D). The above treatment will continue until the criteria for withdrawal from study treatment are met, whichever occurs first. Subjects will receive yttrium \[90Y\] microsphere injection alone or in combination with camrelizumab and/or apatinib for up to 18 months. The primary endpoint of the Phase 2 study is ORR assessed by BICR based on mRECIST criteria. The key secondary endpoint is PFS assessed by BICR based on mRECIST criteria.

Conditions

• HCC

Interventions

Type	Name	Description
DRUG	Yttrium [90Y] Microsphere Injection	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
OTHER	Conventional transcatheter arterial chemoembolization	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).
DRUG	Camrelizumab	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
DRUG	Apatinib	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

Timeline

• Start date: 2025-08-22
• Primary completion: 2027-12-30
• Completion: 2027-12-30
• First posted: 2026-01-12
• Last updated: 2026-01-12

Locations

3 sites across 1 country: China