Status:
RECRUITING
Immune Checkpoint Inhibitors and Anti-vascular Endothelial Growth Factor Antibody/tyrosine Kinase Inhibitors with or Without HAIC for Advanced HCC
Lead Sponsor:
Zhongda Hospital
Conditions:
Hepatocellular Carcinoma (HCC)
Eligibility:
All Genders
18-80 years
Brief Summary
Tyrosine kinase inhibitors (TKIs) plus programmed death-1 (PD-1) inhibitors are recommended for patients with advanced hepatocellular carcinoma (HCC) in China. However, these treatments have limited s...
Detailed Description
The multiple real-world studies have shown that Tyrosine kinase inhibitors (TKIs) plus programmed death-1 (PD-1) inhibitors (TKIs-P) does not result in a high response rate or extended survival for pa...
Eligibility Criteria
Inclusion
- Has a diagnosis of HCC confirmed by radiology, histology, or cytology;
- Barcelona Clinic Liver Cancer (BCLC) stage B/C;
- Has not received any previous systemic therapy for HCC (including chemotherapy, molecularly targeted therapy, immunotherapy);
- Both PD-1/PD-L1 inhibitors and anti-angiogenesis drugs patients received only include marketed drugs but are not limited to HCC approval;
- HAIC was performed after the first PD-1/PD-L1 inhibitor/anti-angiogenic drug treatment or before treatment (within 3 months);
- Received at least 1 cycle of PD-1/PD-L1 inhibitor/anti-angiogenic drug combination therapy after HAIC treatment;
- Has repeated measurable intrahepatic lesions;
Exclusion
- Cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed hepatocellular/cholangiocarcinoma subtypes(confirmed by histology, or pathology) are not eligible;
- Unable to meet criteria of combination timeframe described above;
- Child-Pugh C or PS\>2 or Severe hepatic encephalopathy
Key Trial Info
Start Date :
June 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 31 2025
Estimated Enrollment :
900 Patients enrolled
Trial Details
Trial ID
NCT06881433
Start Date
June 1 2018
End Date
October 31 2025
Last Update
March 18 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Zhongda Hospital
Nanjing, Jiangsu, China