- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03427242
Apatinib for Advanced Biliary Carcinoma
February 2, 2018 updated by: Weijian Guo, Fudan University
A Phase II Study of Apatinib Treatment for Advanced Biliary Tract Carcinoma After Failure of the First-line Chemotherapy
This is a phase II open-label, one-arm, single-center study of apatinib for eligible patients with advanced biliary tract carcinoma after the first-line treatment failure.
A total of 55 patients is planned for enrollment.
The time for enrollment is from Nov 2017 to Nov 2020, the the follow-up will be ended after Nov 2021.
Patients in the study would receive oral apatinib 500-750mg qd until progression of disease.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
55
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Chenchen Wang, MD
- Phone Number: +8613774232040
- Email: wccnancy2003@aliyun.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200032
- Recruiting
- Fudan University Shanghai Cancer Center
-
Contact:
- Chenchen Wang, MD
- Phone Number: +8613774232040
- Email: wccnancy2003@aliyun.com
-
Principal Investigator:
- Weijian Guo, MD,PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients age between 18 and 70 years
- Histologically confirmed advanced biliary tract carcinoma (BTC) or metastatic BTC
- Prior lack of response or intolerance to at least one chemotherapeutic regimens (including gemcitabine).
- At least one measurable lesion as defined by RECIST 1.1
- An Eastern Cooperative Oncology Group performance status of 0 to 2
- Life expectancy ≥ 12 weeks
- For those who received other anti-tumor treatment, the damage should have been restored, with the time interval from last dose of nitroso or mitomycin≥6 weeks and interval from last dose of other cytotoxic drugs, radiation or surgery (the wound should be healed completely) ≥4 weeks.
- Acceptable hematologic, hepatic, and renal function within 7 days from screening: the blood ANC count≥1.5x109 /L; hemoglobin ≥ 9.0 g/dl,the blood platelet count≥80 x109 /L, total bilirubin < 1.5 x ULN, ALT and AST< 2.5 x ULN(< 5 x ULN for patients with live metastasis), serum creatinine≤1 x ULN,endogenous creatinine clearance rate >50ml/min
- Women of reproductive age need to take effective contraceptive measures
Exclusion Criteria:
- With other malignant tumor in 5 years,except for cured cervical carcinoma in situ or basal cell carcinoma.
- Uncontrolled blood pressure on medication (140/90 mmHg); patients with > Grade 1 coronary heart disease, cardiac arrhythmias or cardiac dysfunction
- Symptomatic brain or meningeal metastasis
- History of uncontrolled seizures, central nervous system dysfunction or mental disorder
- Uncontrolled pleural or peritoneal effusion
- Undergoing dialysis
- Severe or uncontrolled infection
- With multiple factors that affecting oral administration
- Abnormal coagulation function or those receiving thrombolytics or anticoagulants
- Patients with tendency of gastrointestinal hemorrhage, including active peptic ulcer with fecal occult blood ++, hematemesis or melena within 3 months
- Participation in other drug clinical trials within 4 weeks
- Weight below 40kg
- urine protein ≥2+
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: treatment arm
oral apatinib
|
oral apatinib 750mg qd
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PFS
Time Frame: from the time signing of ICF until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
|
progression free survival
|
from the time signing of ICF until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
OS
Time Frame: from the time signing of ICF until the date of death from any cause, assessed up to 48 months
|
overall survival
|
from the time signing of ICF until the date of death from any cause, assessed up to 48 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Weijian Guo, MD, Shanghai Cancer Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Li J, Qin S, Xu J, Xiong J, Wu C, Bai Y, Liu W, Tong J, Liu Y, Xu R, Wang Z, Wang Q, Ouyang X, Yang Y, Ba Y, Liang J, Lin X, Luo D, Zheng R, Wang X, Sun G, Wang L, Zheng L, Guo H, Wu J, Xu N, Yang J, Zhang H, Cheng Y, Wang N, Chen L, Fan Z, Sun P, Yu H. Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Apatinib in Patients With Chemotherapy-Refractory Advanced or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction. J Clin Oncol. 2016 May 1;34(13):1448-54. doi: 10.1200/JCO.2015.63.5995. Epub 2016 Feb 16.
- Valle J, Wasan H, Palmer DH, Cunningham D, Anthoney A, Maraveyas A, Madhusudan S, Iveson T, Hughes S, Pereira SP, Roughton M, Bridgewater J; ABC-02 Trial Investigators. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med. 2010 Apr 8;362(14):1273-81. doi: 10.1056/NEJMoa0908721.
- Li J, Qin S, Xu J, Guo W, Xiong J, Bai Y, Sun G, Yang Y, Wang L, Xu N, Cheng Y, Wang Z, Zheng L, Tao M, Zhu X, Ji D, Liu X, Yu H. Apatinib for chemotherapy-refractory advanced metastatic gastric cancer: results from a randomized, placebo-controlled, parallel-arm, phase II trial. J Clin Oncol. 2013 Sep 10;31(26):3219-25. doi: 10.1200/JCO.2013.48.8585. Epub 2013 Aug 5.
- Cereda S, Belli C, Rognone A, Mazza E, Reni M. Second-line therapy in advanced biliary tract cancer: what should be the standard? Crit Rev Oncol Hematol. 2013 Nov;88(2):368-74. doi: 10.1016/j.critrevonc.2013.05.010. Epub 2013 Jun 17.
- Peng H, Zhang Q, Li J, Zhang N, Hua Y, Xu L, Deng Y, Lai J, Peng Z, Peng B, Chen M, Peng S, Kuang M. Apatinib inhibits VEGF signaling and promotes apoptosis in intrahepatic cholangiocarcinoma. Oncotarget. 2016 Mar 29;7(13):17220-9. doi: 10.18632/oncotarget.7948.
- Wang C, Huang M, Geng Q, Li W, Chang J, Tang W, Guo W. Apatinib for patients with metastatic biliary tract carcinoma refractory to standard chemotherapy: results from an investigator-initiated, open-label, single-arm, exploratory phase II study. Ther Adv Med Oncol. 2021 Aug 31;13:17588359211039047. doi: 10.1177/17588359211039047. eCollection 2021.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2017
Primary Completion (Anticipated)
October 31, 2021
Study Completion (Anticipated)
October 31, 2022
Study Registration Dates
First Submitted
January 25, 2018
First Submitted That Met QC Criteria
February 2, 2018
First Posted (Actual)
February 9, 2018
Study Record Updates
Last Update Posted (Actual)
February 9, 2018
Last Update Submitted That Met QC Criteria
February 2, 2018
Last Verified
November 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Digestive System Neoplasms
- Biliary Tract Diseases
- Carcinoma
- Biliary Tract Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Apatinib
Other Study ID Numbers
- FDZL-BTA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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