Lenvatinib for Unresectable Intrahepatic Cholangiocarcinoma
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|ClinicalTrials.gov Identifier: NCT03801499|
Recruitment Status : Suspended (Protocol modification)
First Posted : January 11, 2019
Last Update Posted : February 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Intrahepatic Cholangiocarcinoma||Drug: Lenvatinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Lenvatinib for Unresectable Intrahepatic Cholangiocarcinoma: a Single-arm, Phase 2 Trial|
|Actual Study Start Date :||September 1, 2018|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Participants received lenvatinib capsules 12 milligram (mg) based on the participant's body weight greater than or equal to (>=) 60 kilogram (kg) or 8 mg based on the participant's body weight less than (<) 60 kg at baseline, orally, once daily (QD) up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
12 mg (or 8 mg) once daily (QD) oral dosing.
- overall survival (OS) [ Time Frame: 12 months ]OS was defined as the duration from the date of randomization until the date of death from any cause. Participants who were lost to follow-up were censored at the last date the participant was known to be alive, and participants who remained alive were censored at the time of data cutoff.
- progression free survival (PFS) [ Time Frame: 12 months ]PFS was defined as the time from the date of randomization to the date of first documentation of disease progression based on modified Response Evaluation Criteria in Solid Tumors (mRECIST), or date of death, whichever occurred first.
- Objective Response Rate (ORR) [ Time Frame: 12 months ]ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) based on mRECIST. CR was defined as disappearance of any intratumoral arterial enhancement in all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of viable (enhancement of arterial phase) target lesions taking as reference to the baseline sum of the diameters of target lesions.
- Adverse Events [ Time Frame: 12 months ]Number of adverse events. Postoperative adverse events were graded based on CTCAE v4.03
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): NCT03801499
|Cancer Center Sun Yat-sen University|
|Guangzhou, Guangdong, China, 510060|
|Principal Investigator:||Ming Shi, MD||Sun Yat-sen University|