Hepatocellular Carcinoma
Conditions
Keywords
hepatocellular carcinoma, immune checkpoint iInhibitors, transarterial chemoembolization, real-world study
Brief summary
The purpose of this study is to id transarterial chemoembolization (TACE) in combination with immune checkpoint inhibitors (ICIs) and molecular targeted therapies in patients with hepatocellular carcinoma (HCC) .
Interventions
None listed
Sponsors
Zhongda Hospital
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Has a diagnosis of HCC confirmed by radiology, histology, or cytology; 2. Has not received any previous systemic therapy for HCC (including chemotherapy, molecularly targeted therapy, immunotherapy); 3. Both PD-1/PD-L1 inhibitors and anti-angiogenesis drugs patients received only include marketed drugs but are not limited to HCC approval; 4. TACE was performed up to 3 months after the first PD-1/PD-L1 inhibitor/anti-angiogenic drug treatment or within 1 month before treatment; 5. Received at least 1 cycle of PD-1/PD-L1 inhibitor/anti-angiogenic drug combination therapy after TACE treatment； 7\. Has repeated measurable intrahepatic lesions according to RECIST v1.1;
Exclusion criteria
1. Cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed hepatocellular/cholangiocarcinoma subtypes(confirmed by histology, or pathology) are not eligible; 2. Unable to meet criteria of combination timeframe described above; 3. Missing follow-up data;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival(OS) | up to approximately 2 years | The OS is defined as the time from the initiation of any combination treatment to death due to any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Specificity | baseline | The specificity of the radiomics artificial intelligence model for identifying optimal candidates among patients who treated TACE in combination with PD-1/PD-L1 inhibitors and molecular target therapy will be calculated. |
| Sensitivity | baseline | The sensitivity of the radiomics artificial intelligence model for identifying optimal candidates among patients who treated TACE in combination with PD-1/PD-L1 inhibitors and molecular target therapy will be calculated. |
| The area under curve (AUC) of Receiver Operating Characteristic (ROC) curves of the radiomics artificial intelligence mode | baseline | The area under curve (AUC) of Receiver Operating Characteristic (ROC) curves of the radiomics artificial intelligence model for identifying optimal candidates among patients who treated TACE in combination with PD-1/PD-L1 inhibitors and molecular target therapy will be calculated. |
| Accuracy | baseline | Defined by a confusion matrix of sensitivity and specificity to true positives and true negatives. |
Countries
China
Contacts
Primary ContactGao-Jun Teng, M.D.
Backup ContactHai-Dong Zhu, M.D.
Outcome results
None listed