NCT03345303

Bortezomib in Intrahepatic Cholangiocellular Carcinoma

Bortezomib in Treating Patients With Intrahepatic Cholangiocellular Carcinoma Featuring PTEN Deficiency

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Zhengang Yuan · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the efficacy and safety of second-line treatment of bortezomib in advanced intrahepatic cholangiocarcinoma patients.Half of participants will receive bortezomib while the other half will receive best supporting care.

Detailed description

There's no standard second-line treatment for advanced intrahepatic cholangiocarcinoma patients. Previous study indicated high mutation/deletion rate of PTEN gene in intrahepatic cholangiocarcinoma and poor prognosis of those patients with PTEN mutation/deletion. The investigators also found that the activity of proteasomes elevated in cholangiocarcinoma cells with PTEN mutation/deletion. So the investigators suppose proteasomes inhibitor could improve prognosis of intrahepatic cholangiocarcinoma patients with PTEN mutation/deletion

Conditions

• Intrahepatic Cholangiocarcinoma

Interventions

Type	Name	Description
DRUG	Bortezomib	Bortezomib Injectable Solution

Timeline

• Start date: 2017-01-01
• Primary completion: 2020-12-01
• Completion: 2022-12-01
• First posted: 2017-11-17
• Last updated: 2017-11-17

Locations

1 site across 1 country: China