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TACE combined with targeted drug and immunotherapy in hepatocellular carcinoma of neoadjuvant therapy

Neoadjuvant Therapy in Hepatocellular Carcinoma: An Exploratory Clinical Study of Immunotherapy Combined with Targeted Drugs and TACE

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200059574
Enrollment
Unknown
Registered
2022-05-04
Start date
2022-04-20
Completion date
Unknown
Last updated
2024-03-18

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

Conditions

hepatocellular carcinoma

Interventions

Experimental group:Immunotherapy combined with targeted drugs and transcatheter arterial chemoembolization

Sponsors

The First Affiliated Hospital of Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years, no gender limit; 2. ECOG PS score 0-1; 3. Patients who meet the diagnostic criteria for hepatocellular carcinoma (Guidelines for Diagnosis and Treatment of Primary Liver Cancer 2022 Edition), whose CNLC stage is IIb-IIIa and who are judged by surgical experts or MDT to be resectable; 4. For patients with high risk of recurrence after hepatocellular carcinoma resection, the recurrence rate of liver cancer was predicted to be > 50% according to the risk predictor of early recurrence before liver cancer surgery; 5. No contraindications for TACE treatment; 6. At least one measurable lesion (RECIST1.1); 7. Child-Pugh class A without ascites; 8. No previous local or systemic treatment; 9. No other systematic malignancies; 10. Normal organ function, and meet the following conditions: neutrophil >=1500/µL; Platelet >=60,000/µL; Hemoglobin > 8.5g /dL; Plasma albumin > 3.0 g/dL; Total bilirubin < 30mmol/L; ALT and AST were lower than 5 times the normal upper limit. INR < 1.7 or PT extension not exceeding 4 seconds; Blood creatinine below 1.5 times the upper limit of normal; 11. The patient himself/herself is aware of the condition and signs a written document.

Exclusion criteria

Exclusion criteria: 1. Received any antitumor therapy for liver cancer in the past; 2. Allergy to contrast media; 3. A history of heart disease or uncontrolled hypertension (>150/100mmHg); 4. History of thrombotic disease or gastrointestinal bleeding within 6 months; 5. Patients with an active infection other than HBV/HCV (grade 2 above the NCI CTC AE version 5.0 definition) or other severe concomitant diseases that do not tolerate treatment; 6. History of other malignancies; 7. History of drug allergy; 8. Pregnant or lactating patients; 9. Patients with autoimmune diseases or other reasons requiring long-term use of glucocorticoids; 10. Other factors that may affect patient enrollment and evaluation results; 11. The investigator assessed patients with poor compliance and could not guarantee treatment and follow-up according to the study protocol.

Design outcomes

Primary

MeasureTime frame
safety;significant pathological reaction;

Secondary

MeasureTime frame
objective response rate;recurrence-free survival;overall survival;

Countries

China

Contacts

Public ContactChen Zhiyu

The First Affiliated Hospital of Military Medical University

minnelide@163.com+86 13983881219

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026