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Apatinib for Advanced Biliary Carcinoma

Sponsor
Fudan University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03427242
Collaborator
(none)
55
Enrollment
1
Location
1
Arm
60
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
55 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
apatinibapatinib
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Study of Apatinib Treatment for Advanced Biliary Tract Carcinoma After Failure of the First-line Chemotherapy
Actual Study Start Date :
Nov 1, 2017
Anticipated Primary Completion Date :
Oct 31, 2021
Anticipated Study Completion Date :
Oct 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: treatment arm

oral apatinib

Drug: Apatinib
oral apatinib 750mg qd

Outcome Measures

Primary Outcome Measures

  1. PFS [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

Secondary Outcome Measures

  1. OS [from the time signing of ICF until the date of death from any cause, assessed up to 48 months]

    overall survival

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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+

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fudan University Shanghai Cancer Center Shanghai Shanghai China 200032

Sponsors and Collaborators

  • Fudan University

Investigators

  • Principal Investigator: Weijian Guo, MD, Shanghai Cancer Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Weijian Guo, MD, Fudan University
ClinicalTrials.gov Identifier:
NCT03427242
Other Study ID Numbers:
  • FDZL-BTA
First Posted:
Feb 9, 2018
Last Update Posted:
Feb 9, 2018
Last Verified:
Nov 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Weijian Guo, MD, Fudan University
biliary tract carcinoma
apatinib
Additional relevant MeSH terms:
Carcinoma
Biliary Tract Neoplasms
Apatinib

Study Results

No Results Posted as of Feb 9, 2018