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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
Sponsor:
Information provided by (Responsible Party):
Shi Ming, Sun Yat-sen University

Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of lenvatinib for patients with unresectable intrahepatic cholangiocarcinoma

Condition or disease Intervention/treatment Phase
Intrahepatic Cholangiocarcinoma Drug: Lenvatinib Phase 2

Detailed Description:
Lenvatinib was non-inferior to sorafenib in overall survival in untreated advanced hepatocellular carcinoma.No study has evaluated the efficacy and safety of lenvatinib in unresectable intrahepatic cholangiocarcinoma. Thus, the investigators carried out this prospective study to find out it.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
Experimental: Lenvatinib
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.
Drug: Lenvatinib
12 mg (or 8 mg) once daily (QD) oral dosing.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Adverse Events [ Time Frame: 12 months ]
    Number of adverse events. Postoperative adverse events were graded based on CTCAE v4.03



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The diagnosis of unresectable ICC
  • Patients must have at least one tumor lesion that can be accurately measured according to mRECIST criteria.
  • With no previous treatment
  • No Cirrhosis or cirrhotic status of Child-Pugh class A only
  • Not amendable to surgical resection ,local ablative therapy and any other cured treatment.
  • The following laboratory parameters:

Platelet count ≥ 50,000/μL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/ L Serum albumin ≥ 32 g/L ASL and AST ≤ 6 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) >1,500/mm3

Exclusion Criteria:

  • Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
  • Known history of HIV
  • History of organ allograft
  • Known or suspected allergy to the investigational agents or any agent given in association with this trial.
  • Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
  • Evidence of bleeding diathesis.
  • Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
  • Known central nervous system tumors including metastatic brain disease

Information from the National Library of Medicine

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


Locations
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China, Guangdong
Cancer Center Sun Yat-sen University
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Ming Shi, MD Sun Yat-sen University

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Responsible Party: Shi Ming, Clinical Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03801499     History of Changes
Other Study ID Numbers: HCC-S073
First Posted: January 11, 2019    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Shi Ming, Sun Yat-sen University:
Intrahepatic Cholangiocarcinoma
Lenvatinib

Additional relevant MeSH terms:
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Cholangiocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Carcinoma
Lenvatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action