A Study to Investigate Apatinib Combined Capecitabine on Adjuvant Therapy of Biliary Carcinoma

NCT03609489 | Unknown Phase 2

• 1 other identifier: HRGX05
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

It is a prospective,parallel study to investigate the saftety and efficacy of Apatinib combined Capacitabine in the adjuvant treatment of the biliary cancinoma after operation.

Conditions

Biliary Carcinoma

Keywords

Biliary cancer; adjuvant therapy; apatinib; capecitabine

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  the length of time during the recruiment and after the progression of the biliary cancer verified by imagine examination

  12 months

Secondary Outcomes (3)

• overall survival

  24 months

• objective response rate

  24 months

• Disease Control rate

  24 months

Study Arms (2)

Test Group

EXPERIMENTAL

Apatinib combined with Capetabine

Drug: Capecitabine; Drug: Apatinib

Control Group

ACTIVE COMPARATOR

Capecitabine

Drug: Capecitabine

Interventions

Capecitabine DRUG

Capecitabine, 1000mg/m2, oral administration, twice daily (once in the morning and once in the evening with an interval of 12 hours, equivalent to a total daily dose of 2000 mg/m2), continuous medication for 14 days and off for 7 days. Every 21 days is a cycle, and there shall be a total of 8 cycles. If the subject is still unable to tolerate toxicity after experiencing two dose adjustments, he/she should be moved out of the group.

Also known as: Xeloda

Control Group; Test Group

Apatinib DRUG

Apatinib, 500 mg, administered orally (after breakfast) once daily from day 1 to day 21 (including day 21) with continuous administration. Every 21 days serve as a cycle. If after 2 dose adjustments, the subject is still unable to tolerate toxicity, he/she should be moved out of the group.

Also known as: Aitan

Test 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:

• Fully aware of the research and voluntarily signed informed consent (informed consent must be signed prior to the execution of any required test procedure);
• Patients received removal of biliary tract cancers that have been confirmed by histology or cytology, including intrahepatic bile duct carcinoma (IHCC), extrahepatic bile duct cancer (EHCC), and gallbladder cancer(GBC);
• Normal function of major organs that meets the following criteria:
• Blood routine examination:
• HB≥90 g/L； ANC≥1.5×109/L； PLT≥60×109/L；
• Biochemical examination:
• ALB ≥29 g/L； ALT and AST\<2.5ULN； TBIL ≤2ULN； Creatinine≤1.5ULN;
• ECOG physical condition scores 0 or 1;
• Fertile male or female patients volunteer to use effective contraception methods during the research period, such as double-barrier contraceptive methods, condoms, oral or injectable contraceptives, intrauterine devices, etc.

You may not qualify if:

• Those who received approved or on-going anti-tumor therapy within 4 weeks before the research;
• Those who received other anti-angiogenic tyrosine kinase inhibitors or monoclonal antibodies that had been approved or under study before the research;
• Abnormal laboratory tests that have significant clinical implication;
• International normalized ratio (INR) ≥ 1.5 or partially activated prothrombin time (APTT) ≥ 1.5 × ULN;
• The patient's current serum potassium, serum magnesium, or serum calcium is below the normal reference range of laboratory test (whether supplemented or not), or \>CTCAE grade 1;
• Patients currently suffering from hypertension that cannot be controlled with drugs;
• The researchers conclude electrolyte abnormalities that are clinically significant;
• There is severe bleeding or hemoptysis in the past or at current stage, or there are thromboembolic events within 12 months;
• Cardiovascular diseases that are clinically significant;
• ECG showed QTcB interval ≥ 480 milliseconds in resting state;
• Suffering from other malignant tumors in the past 5 years, excluding basal cell carcinoma or squamous cell carcinoma after receiving radical surgery, or carcinoma in situ of cervix;
• Active or uncontrollable serious infection (≥ CTCAE grade 2 infection), including but not limited to human immunodeficiency virus (HIV) infection;
• Known history of liver disease with evident significance;
• The patient currently has brain metastasis or spinal compression, except individual cases.

Sponsors & Collaborators

• First Affiliated Hospital of Guangxi Medical University: lead

Study Sites (1)

First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 530021, China

Location

Related Publications (1)

• Luvira V, Satitkarnmanee E, Pugkhem A, Kietpeerakool C, Lumbiganon P, Pattanittum P. Postoperative adjuvant chemotherapy for resectable cholangiocarcinoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD012814. doi: 10.1002/14651858.CD012814.pub2.

  PMID: 34515993 DERIVED

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

Capecitabine; apatinib

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Jie Ma, doctor

  First Affiliated Hospital of Guangxi Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jie Ma, doctor

CONTACT

18994127461; 18994127461@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy director

Study Record Dates

• First Submitted: July 24, 2018
• First Posted: August 1, 2018
• Study Start: September 10, 2018
• Primary Completion: June 10, 2021
• Study Completion: December 25, 2021
• Last Updated: August 9, 2018

Record last verified: 2018-08

Locations

CN (1)