NCT03579771

Gemcitabine, Cisplatin, and Nab-Paclitaxel Before Surgery in Patients With High-Risk Liver Bile Duct Cancer

A Single-Arm Feasibility Study of Gemcitabine, Cisplatin, and Nab-Paclitaxel as Neoadjuvant Therapy for Resectable Oncologically High-Risk Intrahepatic Cholangiocarcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well gemcitabine, cisplatin, and nab-paclitaxel work before surgery in treating participants with high-risk bile duct cancer in the liver (intrahepatic cholangiocarcinoma). Drugs used in chemotherapy, such as nab-paclitaxel, cisplatin, and gemcitabine, 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. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Detailed description

PRIMARY OBJECTIVE: To assess the feasibility of therapeutic approach that includes neoadjuvant chemotherapy including gemcitabine hydrochloride (gemcitabine), cisplatin, and nab-paclitaxel for high-risk but technically resectable intrahepatic cholangiocarcinoma and is completed with surgical resection. SECONDARY OBJECTIVES: I. To assess the radiological response rate to neoadjuvant systemic chemotherapy according to the Response Evaluation Criteria in Solid Tumors (RECIST). II. To determine the R0 resection rate. III. To determine patient recurrence-free survival (RFS). IV. To identify patient overall survival (OS) rate. OUTLINE: Participants receive nab-paclitaxel intravenously (IV) over 30 minutes, cisplatin IV over 60 minutes, and gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Participants with stable disease (SD), partial response (PR), or complete response (CR) then undergo standard of care hepatectomy with portal lymphadenectomy. After completion of study treatment, participants are followed up every 4 months for 3 years.

Conditions

• Resectable Cholangiocarcinoma
• Stage IB Intrahepatic Cholangiocarcinoma AJCC v8
• Stage II Intrahepatic Cholangiocarcinoma AJCC v8
• Stage III Intrahepatic Cholangiocarcinoma AJCC v8
• Stage IIIA Intrahepatic Cholangiocarcinoma AJCC v8
• Stage IIIB Intrahepatic Cholangiocarcinoma AJCC v8

Interventions

Type	Name	Description
DRUG	Cisplatin	Given IV
DRUG	Gemcitabine	Given IV
DRUG	Nab-paclitaxel	Given IV

Timeline

• Start date: 2018-09-26
• Primary completion: 2023-09-16
• Completion: 2023-09-16
• First posted: 2018-07-09
• Last updated: 2025-08-15
• Results posted: 2025-08-15

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study