Immune Checkpoint Inhibitors and Anti-vascular Endothelial Growth Factor Antibody/tyrosine Kinase Inhibitors with or Without Hepatic Arterial Infusion Chemotherapy As First-line Treatment for Advanced Hepatocellular Carcinoma

Status: Recruiting
Location: See location...
Study Type: Observational
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 survival benefit in patients with advanced HCC. We aimed to investigate whether hepatic arterial infusion chemotherapy (HAIC) in combination with TKIs and PD-1 inhibitors could improve the efficacy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
View:

• 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;

Locations
Other Locations
China
Zhongda Hospital
RECRUITING
Nanjing
Contact Information
Primary
Gao-Jun Teng, M.D
gjteng@vip.sina.com
+86-02583272121
Backup
Hai-Dong Zhu, M.D
+86-02583272121
Time Frame
Start Date: 2018-06-01
Estimated Completion Date: 2025-10-31
Participants
Target number of participants: 900
Related Therapeutic Areas
Sponsors
Leads: Zhongda Hospital

This content was sourced from clinicaltrials.gov

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