Lenvatinib Combined Pembrolizumab in Advanced Hepatobiliary Tumors
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Biomarker
- Cholangiocarcinoma
- Combinational Immunotherapy
- Liver Neoplasm Malignant Primary
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Patients were confirmed with advanced hepatobiliary malignancies by imaging and histological examination and meet with the inclusive criteria, including hepatocellular carcinoma, cholangiocarcinoma, ampullary carcinoma, gallbladder carcinoma, and mixed cancer)Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This trial is a single-arm, non-randomized and single-center clinical study of targeted therapy combined immunotherapy in patients with hepatobiliary malignant tumors. It is estimated that 50 patients who met the study criteria will be enrolled in PUMCH and treated with lenvatinib and pembrolizumab....
This trial is a single-arm, non-randomized and single-center clinical study of targeted therapy combined immunotherapy in patients with hepatobiliary malignant tumors. It is estimated that 50 patients who met the study criteria will be enrolled in PUMCH and treated with lenvatinib and pembrolizumab. The investigators will follow up and collect subjects' data each month to evaluate the efficacy and safety of treatment, including overall survival and time to progression. Multi-omics data analysis will be used to find potential biomarkers of treatment response.
Tracking Information
- NCT #
- NCT03895970
- Collaborators
- Not Provided
- Investigators
- Study Chair: Haitao Zhao, Prof Peking Union Medical College Hospital (PUMCH)
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