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

NCT07334483 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-01-12

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • GrandPharma (China) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Zhiping Yan, MD · Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-22
Primary Completion
2027-12-30
Completion
2027-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07334483 on ClinicalTrials.gov