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Phase 2 clinical study of local consolidation therapy combined with first-line hepatic artery infusion chemotherapy (FOLFOX-HAIC) and immunotherapy for oligo-residual disease in advanced hepatocellular carcinoma

Phase 2 clinical study of local consolidation therapy combined with first-line hepatic artery infusion chemotherapy (FOLFOX-HAIC) and immunotherapy for oligo-residual disease in advanced hepatocellular carcinoma

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113517
Enrollment
Unknown
Registered
2025-12-01
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

hepatocellular carcinoma

Interventions

Test group:Local consolidation therapy combined with first-line hepatic artery infusion chemotherapy and immunotherapy
Control group:First line hepatic artery infusion chemotherapy and immunotherapy

Sponsors

Yueyang Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Age range: 18-75 years old, male or female not limited; 2.Diagnosed as HCC through pathology or clinical examination (meeting AASLD criteria); 3. BCLC stage B or C, Child Pugh grade A or B7 (bilirubin = 1.5 × 10 ?/L, platelets >= 75 × 10 ?/L, hemoglobin = 90 g/L; Liver function: ALT/AST = 60 mL/min (calculated according to the Cockcroft Gault formula); 7.The patient voluntarily signs the informed consent form, has good compliance, and is able to cooperate with follow-up.

Exclusion criteria

Exclusion criteria: 1. Previously received LCT (radiotherapy, ablation, TACE, etc.); 2. Combination of severe underlying diseases such as heart, lung, kidney, etc. (such as NYHA heart function = III, severe chronic obstructive pulmonary disease); 3. Active autoimmune diseases or the need for long-term use of glucocorticoids (dose>10 mg/d prednisone equivalent dose); 4. Previous history of severe irAEs treated with immunotherapy (such as grade 3-4 pneumonia and colitis); 5. Pregnant or lactating women; 6. Merge with other malignant tumors (excluding skin basal cell carcinoma or cervical carcinoma in situ cured for more than 5 years); 7. Uncontrollable infections (such as HBV DNA>1 × 10 4 IU/mL, without antiviral treatment).

Design outcomes

Primary

MeasureTime frame
progression-free survival (PFS);

Secondary

MeasureTime frame
objective response rate(ORR);disease control rate(DCR);overall survival(OS);adverse events(AEs);

Countries

China

Contacts

Public Contactzhan dahe

Yueyang Central Hospital

zhandahe2006@163.com+86 139 7500 1945

Outcome results

None listed

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