Apatinib as Second Line Therapy in Patients With Advanced Refractory B

Apatinib as Second Line Therapy in Patients With Advanced Refractory Biliary Tract Cancers

https://clinicaltrials.gov/ct2/show/NCT03144856

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Purpose
This study is designed to see whether Apatinib is effective in treating patients with advanced refractory biliary tract cancers.

Condition Intervention Phase
Biliary Tract Cancer
Drug: Apatinib
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention Model Description:
Apatinib single agent
Masking: No masking
Primary Purpose: Treatment
Official Title: Phase II Study of Apatinib as Second Line Therapy in Patients With Advanced Refractory Biliary Tract Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer
Genetic and Rare Diseases Information Center resources: Biliary Tract Cancer
U.S. FDA Resources

Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
Progression-free survival (PFS) [ Time Frame: Approximately 1 year ]
the time from randomize to progression or death; RECIST guidelines were used to define all responses after patients had received every 4 weeks of therapy

Secondary Outcome Measures:
Overall survival (OS) [ Time Frame: Approximately 2 years ]
Defined as the time from randomize to death

Disease control rate(DCR) [ Time Frame: Approximately 1 year ]
Defined as the rate of complete response , partial response and stable disease according to RECIST guidelines

Quality of life(QoL) [ Time Frame: Approximately 1 year ]
As measured by the European Organization for Research and Treatment of Cancer questionnaire (EORTC QLQ C30)

Safety (incidence of adverse events) [ Time Frame: Approximately 1 year ]
Incidence of adverse events

Estimated Enrollment: 39
Actual Study Start Date: February 22, 2017
Estimated Study Completion Date: March 1, 2019
Estimated Primary Completion Date: March 1, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Apatinib group
Apatinib 500mg, po, QD, every 4 weeks.
Drug: Apatinib
Apatinib 500mg, po, qd, every 4 weeks.

Detailed Description:
Biliary tract cancers (BTC) includes cholangiocarcinoma and gallbladder carcinoma (GBC). The systematic treatment based on gemcitabine plus cisplatin is recommended as the current standard chemotherapy for unresectable or metastatic BTC. There is no standard recommendation for second line therapy.

Apatinib is a tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor 2(VEGFR-2).

This study was conducted to assess the efficacy and safety of Apatinib in patients with advanced refractory BTC who had received first-line chemotherapy.

Eligibility

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

Must have histologically or cytologically documented carcinoma primary to the intra- or extra-hepatic biliary system or gall bladder with clinical and/or radiologic evidence of unresectable, locally advanced or metastatic disease.
Patients with ampullary carcinoma are not eligible.
Must have failed or are intolerant to one line of systemic treatment but no more than 2 prior lines of systemic chemotherapy for advanced BTC. Patients who received adjuvant chemotherapy and had evidence of disease recurrence within 6 months of completion of the adjuvant treatment are also eligible. If the patient received adjuvant treatment and had disease recurrence after 6 months, patients will only be eligible after failing or having intolerance to one line of systemic chemotherapy used to treat the disease recurrence.
Age between 18 and 75 years old
Eastern Cooperative Oncology Group (ECOG) Performance Status Assessment of 0 or 1.
Must have radiographic measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Life expectancy of at least 12 weeks (3 months).
For patients who have received prior radiation, cryotherapy, radiofrequency ablation, therasphere, ethanol injection, transarterial chemoembolization (TACE) or photodynamic therapy, the following criteria must be met: 28 days have elapsed since that therapy; Lesions that have not been treated with local therapy must be present and measureable.
Must be able to understand and be willing to sign the written informed consent form. Must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other study requirements.
All acute toxic effects of any prior treatment have resolved to NCI-CTCAE v4.0 Grade 1 or less at the time of signing the Informed Consent Form (ICF) except for alopecia.
Adequate bone marrow, liver and liver function.
Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of study drug.
Men and women of childbearing potential must agree to use adequate contraception beginning at the signing of the ICF until at least 3 months after the last dose of study drug.
Exclusion Criteria:

Pregnant or lactating women;
History of other malignancies except cured basal cell carcinoma of skin and carcinoma insitu of uterine cervix;
Uncontrolled hypertension;
Intercurrence with one of the following: coronary artery disease, arrhythmia and heart failure;
Urine protein>grade 1;
Any factors that influence the usage of oral administration;
Patients with a clear tendency of gastrointestinal bleeding;
Abnormal coagulation function(INR≥1.5, APTT≥1.5 ULN);
Abuse of alcohol or drugs;
Less than 4 weeks from the last clinical trial;
Prior treatment with antivascular endothelial growth factor or the other anti angiogenesis therapy;
Active central nervous system (CNS). If CNS metastases are treated and potential participants are at neurologic baseline for at least 2 weeks prior to enrollment, they will be eligible but will need a Brain MRI prior to enrollment. 13. Disability of serious uncontrolled intercurrence infection.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03144856

Contacts
Contact: Feng-Hua Wang, MD, PhD 86-020-87342490 wangfh@sysucc.org.cn

Locations
China, Guangdong
Foshan people’s Hospital Recruiting
Foshan, Guangdong, China
Contact: Wei Wang 075783161035 m18038863618@163.com
Cancer center of Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Fenghua Wang, MD, PhD 86-020-87342490 wangfh@sysucc.org.cn
Contact: Miao-Zhen Qiu, MD, PhD 86-020-87342490 qiumzh@sysucc.org.cn
Principal Investigator: Rui-Hua Xu, MD, PhD
Sponsors and Collaborators
Sun Yat-sen University
Jiangsu HengRui Medicine Co., Ltd.
Investigators
Principal Investigator: Rui-Hua Xu, MD, PhD Sun Yat-sen University
More Information

Responsible Party: Fenghua Wang, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03144856 History of Changes
Other Study ID Numbers: Apatinib_BTC
Study First Received: May 5, 2017
Last Updated: May 8, 2017
Individual Participant Data
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sun Yat-sen University:
Biliary Tract Cancer
Second line thrapy
Apatinib

Additional relevant MeSH terms:
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Biliary Tract Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 12, 2017