Apatinib for Advanced Biliary Carcinoma

Biliary Tract Neoplasms Clinical Trial

Official title:

A Phase II Study of Apatinib Treatment for Advanced Biliary Tract Carcinoma After Failure of the First-line Chemotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03427242
• Other study ID #: FDZL-BTA
• Status: Recruiting
• Phase: Phase 2
• First received: January 25, 2018
• Last updated: February 2, 2018
• Start date: November 1, 2017
• Est. completion date: October 31, 2022

Study information

• Verified date: November 2017
• Source: Fudan University
• Contact: Chenchen Wang, MD
• Phone: +8613774232040
• Email: wccnancy2003[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Patients age between 18 and 70 years

2. Histologically confirmed advanced biliary tract carcinoma (BTC) or metastatic BTC

3. Prior lack of response or intolerance to at least one chemotherapeutic regimens (including gemcitabine).

4. At least one measurable lesion as defined by RECIST 1.1

5. An Eastern Cooperative Oncology Group performance status of 0 to 2

6. Life expectancy = 12 weeks

7. 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.

8. 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

9. Women of reproductive age need to take effective contraceptive measures

Exclusion Criteria:

1. With other malignant tumor in 5 years,except for cured cervical carcinoma in situ or basal cell carcinoma.

2. Uncontrolled blood pressure on medication (140/90 mmHg); patients with > Grade 1 coronary heart disease, cardiac arrhythmias or cardiac dysfunction

3. Symptomatic brain or meningeal metastasis

4. History of uncontrolled seizures, central nervous system dysfunction or mental disorder

5. Uncontrolled pleural or peritoneal effusion

6. Undergoing dialysis

7. Severe or uncontrolled infection

8. With multiple factors that affecting oral administration

9. Abnormal coagulation function or those receiving thrombolytics or anticoagulants

10. Patients with tendency of gastrointestinal hemorrhage, including active peptic ulcer with fecal occult blood ++, hematemesis or melena within 3 months

11. Participation in other drug clinical trials within 4 weeks

12. Weight below 40kg

13. urine protein =2+

Related Conditions & MeSH terms

• Biliary Tract Neoplasms
• Carcinoma

Intervention

Drug:
• Apatinib
oral apatinib 750mg qd

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

References & Publications (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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS	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	OS	overall survival	from the time signing of ICF until the date of death from any cause, assessed up to 48 months