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A Prospective Phase II Study of CBCT-Guided Staged TACE Combined with Immediate HAIC and Systemic Therapy for Unresectable Massive (>10cm) Hepatocellular Carcinoma

A Prospective Phase II Study of CBCT-Guided Staged TACE Combined with Immediate HAIC and Systemic Therapy for Unresectable Massive (>10cm) Hepatocellular Carcinoma

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111040
Enrollment
Unknown
Registered
2025-10-24
Start date
2025-10-25
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Massive (>10cm) HCC

Interventions

Experimental group:Stage-wise ACE HAIC systemic treatment under CBCT guidance (TKI ICI)

Sponsors

Henan Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Age 18 to 80 years old, with no gender restrictions; 2.Newly diagnosed patients who are too old, have insufficient residual liver, or are unwilling to undergo surgical resection; or patients who have experienced a first recurrence after achieving a cure through surgery or ablation; 3.Diagnosed with HCC based on histopathology or the "Diagnosis and Treatment Guidelines for Primary Liver Cancer (2024 Edition) in China"; 4.Massive HCC (>=10 cm), which may be accompanied by sub-nodules (total number of tumors = 3.0×10^9/L, PLT >= 50×10^9/L, Hb >= 70g/L; serum creatinine <= 1.5×ULN (upper limit of normal); ALT <= 5.0×ULN, AST <= 5.0×ULN.

Exclusion criteria

Exclusion criteria: 1.A second or more primary malignant tumors; 2.Hepatic artery-venous fistula or hepatic artery-portal vein fistula (central type); 3.Diffuse HCC, main portal vein invasion, or extrahepatic metastatic lesions; 4.Severe coagulation, cardiopulmonary or other functional disorders; 5.Active hepatitis or severe infection that cannot be corrected; 6.Cachexia or multiple organ failure; 7.Allergic to chemotherapy drugs; 8.Uncontrollable neurological, mental disorders or mental illness, poor compliance, and inability to cooperate and describe treatment responses; 9.Pregnant or lactating women; 10.Contraindications for hepatic artery procedures; 11.Uncontrolled active hepatitis; 12.Investigator deems the patient unsuitable for participation in this trial.

Design outcomes

Primary

MeasureTime frame
Progression free survival, PFS;Objective response rate,ORR;

Secondary

MeasureTime frame
Adverse event, AE;Surgical conversion rate;Disease control rate,DCR;Overall survival,OS;

Countries

China

Contacts

Public ContactXiao Jincheng

Henan Cancer Hospital

1377239957@qq.com+86 371 65587256

Outcome results

None listed

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