NCT06881433Completed
Immune Checkpoint Inhibitors and Anti-vascular Endothelial Growth Factor Antibody/Tyrosine Kinase Inhibitors With or Without HAIC for Unresectable HCC With Portal Vein Tumor Thrombosis
Source: ClinicalTrials.gov · Last updated 11 May 2026
Brief summary (registry, in English)
Anti-vascular endothelial growth factor antibody/tyrosine kinase inhibitors (VEGF/TKI-ICI) plus Immune checkpoint inhibitors (ICIs) are recommended for patients with unresectable hepatocellular carcinoma (HCC) with PVTT in China. However, these treatments have limited survival benefit in patients with advanced HCC with PVTT. We aimed to investigate whether hepatic arterial infusion chemotherapy (HAIC) in combination with VEGF/TKI-ICI and ICIs could improve the efficacy.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 1649 (actual)
- First submitted
- 12 Mar 2025
- Start date
- 1 Jun 2018
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- Zhongda Hospital
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06881433
What you commit to
- Study type: Observational
- Participants enrolled: 1649
- From 1 Jun 2018 to the primary completion date, 31 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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
Who the study is looking for
- Has a diagnosis of HCC confirmed by radiology, histology, or cytology;
- Barcelona Clinic Liver Cancer (BCLC) stage C (HCC with PVTT);
- 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 2 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;
Age in the registry: 18 years to 80 years · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhongda Hospital Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.