Clinical trial NCT03609489: A Study to Investigate Apatinib Combined Capecitabine on Adjuvant Therapy of Biliary Carcinoma
Official title: Apatinib Combined Capecitabine Versus Capecitabine Alone for Adjuvant Therapy in Patients After Biliary Carcinoma Surgery: a Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Biliary Carcinoma
Keywords: Biliary cancer
adjuvant therapy
apatinib
capecitabine
Lead sponsor: First Affiliated Hospital of Guangxi Medical University
Sponsor class: OTHER
First posted: 2018-08-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Subjects were randomly divided into experimental and control groups. The experimental group was postoperatively treated with apatinib combined with capecitabine for adjuvant therapy of biliary cancer, and the control group was treated with capecitabine alone.

Progression free survival (PFS), overall survival (OS), time to progression (TTP), objective response rate (ORR), disease control rate (DCR), EORTC QLQ-C30, HCC-18 and drug safety: vital signs, laboratory indicators, adverse event (AE), and serious adverse event (SAE), drug-related AE and SAE and their specific AE (such as hypertension, proteinuria, and hand-foot syndrome) were followed for research in the two groups to evaluate the efficacy and safety of the two regimens for the treatment of biliary tract cancer according to the standard of NCI-CTCAE V4.0.

A rigorous, randomized and prospective study was conducted to compare the efficacy and safety in treating biliary cancer between the combined use of apatinib mesylate plus capecitabine and capecitabine alone, with a view to improving the survival outcome and life quality of patients with biliary tract cancer.

Eligibility criteria: Inclusion Criteria:

* 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.
* Fertile and non-lactational female who show negative in serum or urine pregnancy test within 7 days before inclusion for the study.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Progression-free survival
timeFrame: 12 months
Secondary outcomes:
measure: overall survival
timeFrame: 24 months
measure: objective response rate
timeFrame: 24 months
measure: Disease Control rate
timeFrame: 24 months
Other outcomes:
Locations:
city: Nanning
country: China
facility: First Affiliated Hospital of Guangxi Medical University
state: Guangxi
Study officials:
affiliation: First Affiliated Hospital of Guangxi Medical University
name: Jie Ma, doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.