NCT03427242

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
55

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2017

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 9, 2018

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2022

Completed
Last Updated

February 9, 2018

Status Verified

November 1, 2017

Enrollment Period

4 years

First QC Date

January 25, 2018

Last Update Submit

February 2, 2018

Conditions

Biliary Tract Neoplasms

Keywords

biliary tract carcinomaapatinib

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • OS

    from the time signing of ICF until the date of death from any cause, assessed up to 48 months

Study Arms (1)

treatment arm

EXPERIMENTAL

oral apatinib

Drug: Apatinib

Interventions

ApatinibDRUG

oral apatinib 750mg qd

treatment arm

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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+

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (6)

  • 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.

    PMID: 23786845BACKGROUND

  • 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.

    PMID: 20375404BACKGROUND

  • 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.

    PMID: 23918952BACKGROUND

  • 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.

    PMID: 26884585BACKGROUND

  • 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.

    PMID: 26967384BACKGROUND

  • 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.

    PMID: 34484431DERIVED

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

apatinib

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsBiliary Tract DiseasesDigestive System Diseases

Study Officials

  • Weijian Guo, MD

    Shanghai Cancer Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chenchen Wang, MD

CONTACT

+8613774232040wccnancy2003@aliyun.com

Study Design

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

Study Record Dates

First Submitted

January 25, 2018

First Posted

February 9, 2018

Study Start

November 1, 2017

Primary Completion

October 31, 2021

Study Completion

October 31, 2022

Last Updated

February 9, 2018

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)