Gemcitabine, Cisplatin, and Nab-Paclitaxel Before Surgery in Patients With High-Risk Liver Bile Duct Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03579771|
Recruitment Status : Active, not recruiting
First Posted : July 9, 2018
Last Update Posted : October 8, 2021
|Condition or disease||Intervention/treatment||Phase|
|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||Drug: Cisplatin Drug: Gemcitabine Drug: Nab-paclitaxel||Phase 2|
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.
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single-Arm Feasibility Study of Gemcitabine, Cisplatin, and Nab-Paclitaxel as Neoadjuvant Therapy for Resectable Oncologically High-Risk Intrahepatic Cholangiocarcinoma|
|Actual Study Start Date :||September 26, 2018|
|Actual Primary Completion Date :||September 16, 2021|
|Estimated Study Completion Date :||September 16, 2023|
Experimental: Gemcitabine, cisplatin, nab-paclitaxel
Participants receive nab-paclitaxel 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.
- Completion of all preoperative and operative therapy [ Time Frame: Up to 12 weeks after study start ]Completion of all therapy rate will be recorded.
- Incidence of adverse events [ Time Frame: Up to 3 years after study start ]Will be monitored using method of Thall, Simon and Estey, and will be tabulated by the maximum reported Common Terminology Criteria for Adverse Events (CTCAE) grade.
- Radiological response rate defined as the percentage of patients who will have complete response (CR), partial response (PR) or stable disease (SD) after the neoadjuvant therapy [ Time Frame: Up to 12 weeks after study start ]Will be evaluated according to Response Evaluation Criteria in Solid Tumor (RECIST).
- Recurrence-free survival (RFS) [ Time Frame: From the date of surgery up to 3 years ]RFS is defined as the time between the date of surgery and the date of disease recurrence or death, whichever occurred first. If a patient did not have an event (i.e. disease recurrence or death) by the time of final analysis, patient will be censored at the last disease evaluation time.
- Overall survival (OS) [ Time Frame: From date of neoadjuvant treatment start up to 3 years ]OS is defined as the time from date of neoadjuvant treatment start to the date of death from any cause or to the date of last follow-up if patients are alive. If a patient is alive by the time of final analysis, the patient will be censored at the last follow-up date.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03579771
|United States, Georgia|
|Emory University Hospital Midtown|
|Atlanta, Georgia, United States, 30308|
|Emory University Hospital/Winship Cancer Institute|
|Atlanta, Georgia, United States, 30322|
|Emory Saint Joseph's Hospital|
|Atlanta, Georgia, United States, 30342|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|United States, Oregon|
|Oregon Health and Science University|
|Portland, Oregon, United States, 97239|
|United States, Texas|
|MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|United States, Washington|
|Benaroya Research Institute at Virginia Mason|
|Seattle, Washington, United States, 98101|
|Principal Investigator:||Shishir Maithel, MD||Emory University|