Cholangiocarcinoma Clinical Trial
Official title:
Phase II Trial of Trifluridine/Tipiracil (FTD/TPI (TAS-102)) in Biliary Tract Cancers
This phase II trial studies how well trifluridine/tipiracil hydrochloride combination agent TAS-102 (TAS-102) works in treating participants with biliary tract cancers that have spread to other places in the body. Drugs used in the chemotherapy, such as trifluridine/tipiracil hydrochloride combination agent TAS-102, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
PRIMARY OBJECTIVES: I. Determine the efficacy of trifluridine/tipiracil hydrochloride combination agent TAS-102 (FTD/TPI [TAS-102]) in patients with refractory cholangiocarcinoma using progression-free survival at 16 weeks. SECONDARY OBJECTIVES: I. Assess the safety and tolerability of FTD/TPI (TAS-102) in patients with refractory cholangiocarcinoma through adverse event monitoring. II. Further explore the efficacy of FTD/TPI (TAS-102) in patients with refractory cholangiocarcinoma by overall response rates, progression-free survival, and overall survival. TERTIARY OBJECTIVES: I. Determine if circulating tumor cells (CTCs) or cell-free deoxyribonucleic acid (DNA) (cfDNA) at baseline correlates with prognosis or response to therapy. II. Determine if change in CTCs or cfDNA correlates with efficacy endpoints. III. Determine if different mutational status of the tumor will affect efficacy endpoints. OUTLINE: Patients receive trifluridine/tipiracil hydrochloride combination agent TAS-102 orally (PO) twice daily (BID) on days 1-5 and 8-12. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and then every 3 months for up to 2 years. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05497531 -
Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers
|
N/A | |
| Recruiting |
NCT05678218 -
Preoperative Evaluation of Lymph Nodes of Cholangiocarcinoma
|
||
| Recruiting |
NCT06010862 -
Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors
|
Phase 1 | |
| Active, not recruiting |
NCT04383210 -
Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors
|
Phase 2 | |
| Recruiting |
NCT05179486 -
Molecular Epidemiology of Biliary Tree Cancers
|
||
| Suspended |
NCT05124743 -
HLA Typing & Tumor Neoantigen Identification for Phase I/II Study of Autologous TCR-T Cells in Subjects With Solid Tumors
|
||
| Terminated |
NCT04304781 -
Phase 1 In-vivo Biliary Study of KSP/QRH Heptapeptide Dimer
|
Phase 1 | |
| Completed |
NCT03150615 -
Enteral Nutrition After Pancreaticoduodenectomy
|
N/A | |
| Completed |
NCT01912053 -
Efficacy Study of Intra-hepatic Administration of Therasphere® in Association With Intravenous Chemotherapy to Treat Cholangiocarcinoma
|
Phase 2 | |
| Recruiting |
NCT01439698 -
Radio Frequency Ablation in the Management of Pancreatico-biliary Disorders: A Multicenter Registry
|
N/A | |
| Terminated |
NCT01434459 -
Study of Gemcitabine With TheraSphere® (Yttrium-90)in Patients With Hepatic Tumors of Pancreatobiliary Origin
|
Phase 1 | |
| Completed |
NCT01206049 -
Combination Chemotherapy Plus Panitumumab or Bevacizumab for Inoperable Cholangiocarcinoma Without KRAS Mutations
|
Phase 2 | |
| Recruiting |
NCT00973713 -
Study of RAD001 in Advanced Cholangiocarcinoma: RADiChol
|
Phase 2 | |
| Terminated |
NCT00975039 -
Study Using WST11 in Patients With Non-Resectable or Inoperable Cholangiocarcinoma
|
Phase 2 | |
| Completed |
NCT00779454 -
Combined Biological Treatment and Chemotherapy for Patients With Inoperable Cholangiocarcinoma
|
Phase 2 | |
| Terminated |
NCT04066491 -
Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) in Participants With 1L BTC
|
Phase 2/Phase 3 | |
| Active, not recruiting |
NCT04526106 -
REFOCUS: A First-in-Human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients With ICC and Other Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Recruiting |
NCT03603834 -
Neoadjuvant mFOLFOXIRI for Potentially Resectable Cholangiocarcinoma
|
Phase 2 | |
| Recruiting |
NCT05007106 -
MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005)
|
Phase 2 | |
| Terminated |
NCT04077372 -
Assessment of a Serious Illness Conversation Guide (SICG) in Advanced Gastro-Intestinal Cancers
|
N/A |