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SIRT combined with low-dose HAIC, tyrosine kinase inhibitors, and immune checkpoint inhibitors: Efficacy and safety evaluations in patients with unresectable large hepatocellular carcinoma

SIRT combined with low-dose HAIC, tyrosine kinase inhibitors, and immune checkpoint inhibitors: Efficacy and safety evaluations in patients with unresectable large hepatocellular carcinoma

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500106646
Enrollment
Unknown
Registered
2025-07-28
Start date
2025-08-01
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular cancer

Interventions

Experimental group:Yttrium-90-SIRT synchronous low-dose oxaliplatitrexed regimen with hepatic arterial perfusion chemotherapy combined with targeted immunotherapy

Sponsors

Fujian Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Male or female patients aged 18~70 years old; 2. ECOG PS: 0~1 points; 3. Patients with HCC diagnosed by the clinical diagnostic criteria of the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2024 Edition) or by histopathological or cytological examination; 4. Patients who have not received any tumor-related radiotherapy and chemotherapy before enrollment; 5. Patients have at least one measurable lesion (measurable lesion CT scan long diameter >=10mm or lymph node lesion CT scan short diameter> according to RECIST 1.1 criteria =15mm, and the measurable lesion has not received local treatment such as radiotherapy or freezing); 6. HCC patients with Chinese liver cancer stage I.b, II.a, II.b or III.a unresectable, or CNLC stage Ib-IIIa that can be resected by MDT but has a high risk of recurrence. 7. Expected survival >= 3 months; 8. No pregnancy or pregnancy plans; 9. Subjects voluntarily join this study, sign the informed consent form, have good compliance, and cooperate with follow-up.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women; 2. ECOG PS: >=2 points; 3. Patients with early liver cancer who meet the CNLC (Chinese liver cancer stage) stage Ia; single tumor, maximum diameter 176.8 µmol/L or Cr clearance >; 50 Gy. 10. History of other malignant tumors within or at the same time within the past 5 years, except for cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and papillary thyroid carcinoma; 11. Uncontrolled cardiac clinical symptoms or diseases, such as: (1) NYHA II or above heart failure, (2) unstable angina, (3) myocardial infarction within 1 year, (4) clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention; 12. Intrahepatic lesions have received external radiation therapy; 13. History of immunodeficiency, including positive HIV test, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation and bone marrow transplantation; 14. History of interstitial lung disease and non-infectious pneumonitis; 15. Patients with active tuberculosis infection found through medical history or CT examination, or a history of active tuberculosis infection within 1 year before enrollment, or patients with a history of active tuberculosis infection before 1 year but without formal treatment; 16. Known history of psychotropic drug abuse, alcohol abuse and drug abuse; 17. Received 2nd line targeted immunotherapy in the past; 18. Those who are not suitable for inclusion in the opinion of the investigator.

Design outcomes

Primary

MeasureTime frame
Conversion percentage;Progression free survival,PFS;Progression free survival,PFS;Objective response rate,ORR;Disease control rate,DCR;

Secondary

MeasureTime frame
Overall Survival,OS;

Countries

China

Contacts

Public ContactMingzhi Hao

Fujian Cancer Hospital

1196819910@qq.com+86 130 6723 1561

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026