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

NCT03144856 | Unknown Phase 2

• 1 other identifier: Apatinib_BTC
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Biliary Tract Cancer

Keywords

Biliary Tract Cancer; Second line thrapy; Apatinib

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  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

  Approximately 1 year

Secondary Outcomes (4)

• Overall survival (OS)

  Approximately 2 years

• Disease control rate(DCR)

  Approximately 1 year

• Quality of life(QoL)

  Approximately 1 year

• Safety (incidence of adverse events)

  Approximately 1 year

Study Arms (1)

Apatinib group

EXPERIMENTAL

Apatinib 500mg, po, QD, every 4 weeks.

Drug: Apatinib

Interventions

Apatinib DRUG

Apatinib 500mg, po, qd, every 4 weeks.

Apatinib group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (2)

Foshan people's Hospital

Foshan, Guangdong, China

RECRUITING

Cancer center of Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

apatinib

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Rui-Hua Xu, MD, PhD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Feng-Hua Wang, MD, PhD

CONTACT

86-020-87342490; wangfh@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Apatinib single agent

Study Record Dates

• First Submitted: May 5, 2017
• First Posted: May 9, 2017
• Study Start: February 22, 2017
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: May 9, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)