Hepatocellular Carcinoma Non-resectable Clinical Trial
Official title:
Clinical Trial of Biomarkers for Predicting Immunotherapy Response in Hepatocellular Carcinoma
This prospective clinical trial will evaluate PET/CT and genomic liquid biopsy based biomarkers as predictors of clinical therapeutic response to immune-checkpoint inhibitor (ICI) therapy for patients with inoperable hepatocellular carcinoma (HCC). The primary objective of this diagnostic trial is to assess the accuracy of pre-treatment fluorine-18 (18F-) fluorocholine (FCH) PET/CT for predicting a lack of objective response (LOR) after 16 weeks of ICI therapy.
This is a prospective open-label single-arm diagnostic clinical trial evaluating fluorine-18 fluorocholine (FCH) PET/CT and cell-free DNA mutation profiling (also referred to as genomic liquid biopsy) as diagnostic tools for predicting therapeutic response in advanced HCC patients receiving immune-checkpoint inhibitor (ICI) therapy. All enrolled subjects will undergo diagnostic testing with FCH PET/CT and genomic liquid biopsy before ICI treatment. A fluorine-18 fluorodeoxyglucose (FDG) PET/CT may also be performed before treatment and after 8 weeks if the pre-treatment FCH PET/CT shows low or heterogeneous tumor uptake. The accuracy of tumor biomarkers based on PET/CT and liquid biopsy for predicting therapeutic outcome and disease progression will be determined using objective clinical endpoints based on the radiographic classification of treatment response by RECIST v1.1 applied to CT or MRI performed after 16 weeks of treatment. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04592029 -
TACE Combined With Sintilimab and Bevacizumab for Unresectable HCC
|
Phase 1 | |
Recruiting |
NCT05953337 -
Radioembolization Trial Utilizing Eye90 Microspheres™ for the Treatment of Hepatocellular Carcinoma (HCC)
|
N/A | |
Not yet recruiting |
NCT03283956 -
Safety and Efficacy of dRug-ElutiNg beADs Trans-arterial chemoEmbolization for Hepatocellular Carcinoma in Taiwan
|
N/A | |
Recruiting |
NCT03652467 -
The Safety and Efficacy of Deferoxamine for Treating Unresectable Hepatocellular Carcinoma
|
Phase 1 | |
Recruiting |
NCT05031949 -
Hyperbaric Oxygen Therapy Combined Camrelizumab in Patients With Advanced/Metastatic Hepatocellular Carcinoma
|
Phase 1 | |
Completed |
NCT03533920 -
Clinical Trial to Evaluate the Efficacy and Safety of UNI-DEB for Unresectable Hepatocellular Carcinoma
|
N/A | |
Recruiting |
NCT05992220 -
Atezolizumab Plus Bevacizumab Alone or Combined With External Beam Radiotherapy for HCC With Macrovascular Invasion
|
Phase 2 | |
Not yet recruiting |
NCT05057104 -
Non-inferiority Study of Unresectable Hepatocelluar Carcinoma Receiving Stereotactic Radiotherapy Combined With Hepatic Arterial Chemoembolization Compared With Conversion Hepatectomy
|
||
Completed |
NCT04599777 -
TACE Combined With Sorafenib and Tislelizumab for Advanced HCC
|
Phase 2 | |
Completed |
NCT04599790 -
TACE Combined With Lenvatinib and Sintilimab for Advanced HCC
|
Phase 2 | |
Recruiting |
NCT02967887 -
Evaluation of Hepatic Arterial Infusion of Cisplatin and 5-FU in Biomarker Stratified HCC
|
Phase 2 | |
Recruiting |
NCT05608200 -
Lenvatinib+Sintilimab+TACE vs. Lenvatinib+TACE for Advanced HCC
|
Phase 3 | |
Recruiting |
NCT05608213 -
Lenvatinib Plus I-125 Seed Brachytherapy vs. Lenvatinib for TACE-refractory HCC
|
Phase 3 | |
Completed |
NCT04926376 -
Safety and Effectiveness of Eye90 Microspheres™ in the Treatment of Unresectable HCC and mCRC
|
N/A | |
Recruiting |
NCT06133062 -
Atezolizumab and Bevacizumab With Proton Radiotherapy for Unresectable Hepatocellular Carcinoma
|
Phase 2 | |
Completed |
NCT02989922 -
A Study to Evaluate SHR-1210 in Subjects With Advanced HCC
|
Phase 2 | |
Recruiting |
NCT04273100 -
PD-1 Monoclonal Antibody, Lenvatinib and TACE in the Treatment of HCC
|
Phase 2 | |
Withdrawn |
NCT03563170 -
QUILT-3.072: NANT Hepatocellular Carcinoma (HCC) Vaccine
|
Phase 1/Phase 2 | |
Recruiting |
NCT05390112 -
Cohort Study of Patients With Hepatocellular Carcinoma and Circulating Tumor DNA Monitoring of Chemoembolization
|
||
Recruiting |
NCT05713994 -
Combined HAIC, TKI/Anti-VEGF and ICIs as Conversion Therapy for Unresectable Hepatocellular Carcinoma
|