drugset / Trial / NCT05170438
Lenvatinib Plus Paclitaxel for Patients With Advanced Biliary Tract Cancer Who Failed to Gemcitabine-based Treatment
Phase 2
Active not recruiting
51 enrolled
National Health Research Institutes, Taiwan
Chang Gung Memorial Hospital · collabChina Medical University, Taiwan · collabKaohsiung Medical University Chung-Ho Memorial Hospital · collabMackay Memorial Hospital · collabNational Cheng-Kung University Hospital · collabNational Taiwan University Hospital · collabTaipei Veterans General Hospital, Taiwan · collab
NaSingle-groupOpen-labelTreatment
Summary
To evaluate the following items in patients with advanced cholangiocarcinoma receiving lenvatinib plus paclitaxel treatment, Primary endpoint: Overall response rate (ORR) by RECIST 1.1 Secondary endpoints Progression-free survival (PFS) Time to progression Overall survival Disease control rate (Overall response rate + stable disease ≧ 4 weeks) Response rate by modified RECIST Association between therapeutic efficacy and tumor vascularity Quality of life Safety profile Predictive biomarker of cholangiocarcinoma
Timeline
- Start
- 2022-07-01
- Primary completion
- 2028-06
- Completion
- 2028-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lenvatinib | Small molecule | 12 mg | Oral |
| Subject | Lenvatinib | Small molecule | 16 mg | Oral |
| Subject | Paclitaxel | Small molecule | 80 mg/m2 | Intravenous |