Phase 1 Study of Apatinib and Capecitabine Combination to Maintain Treating Metastatic Colorectal Cancer

Yanqiao Zhang0 sites40 target enrollmentApril 30, 2017

ConditionsMetastatic Colorectal Cancer

Interventions"Capecitabine""Apatinib" and "Capecitabine"

Drugs"Apatinib" and "Capecitabine""Capecitabine"

Overview

Phase: Phase 2
Intervention: "Capecitabine"
Conditions: Metastatic Colorectal Cancer
Sponsor: Yanqiao Zhang
Enrollment: 40
Primary Endpoint: Progression-free Survival of Patients with Apatinib and Capecitabine Combination That is prolonged
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

To control apatinib and capecitabine combination to maintain treating metastatic colorectal cancer.

Detailed Description

To control apatinib and capecitabine combination to maintain treating metastatic colorectal cancer,primary endpoint include in mPFS; secondary endpoint include in mOS, tolerance and security.

Registry

clinicaltrials.gov

Start Date

April 30, 2017

End Date

April 30, 2018

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Yanqiao Zhang

Responsible Party

Sponsor Investigator

Principal Investigator

Yanqiao Zhang

Head of Gastroenterology

Harbin Medical University

Eligibility Criteria

Inclusion Criteria

•Informed consent form should be issued prior to conducting any research process;
•Men or women aged 18-75 years;
•Patients with advanced and / or metastatic colorectal cancer confirmed by histology or cytology;
•Patients who has not exposed to apatinib previously and had received oxaliplatin combined with fluorouracil chemotherapy;
•The estimated survival time is longer than 3 months;
•ECOG score was 0 or 1;
•According to the RECIST v1.1 guidance, at least 1 lesion(who had not received radiotherapy) showed that the longest diameter≥10mm(except for lymph node, the short axis of the lymph node must be≥15mm) through CT or MRI(intravenous contrast agent was preferred ) accurate measurement and the lesion should be suitable for repeatable and accurate measurement; the lesion located in the previously irradiated area can be used as a measurable lesion if the lesion was proved in progress;
•With sufficient organ and bone marrow function, defined as follows:
•Hb≥9 g/dL
•Absolute neutrophil count ≥1.0 × 109 /L

Exclusion Criteria

•Patients with hypertension and can not be reduced to the normal range with antihypertensive drugs(systolic pressure \>140 mmHg / diastolic pressure \> 90 mmHg),patients with coronary heart disease more than grade II, arrhythmia (including QTc interval Prolongation men\>450 ms, women \>470 ms) and cardiac insufficiency;
•With a variety of factors affecting oral drugs(such as unable to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction, etc.);
•Special note: patients with the risk of gastrointestinal bleeding can not be included, including the following: active peptic ulcer lesions and fecal occult blood (+ +); patients with melena and hematemesis in 3 months; for patients with fecal occult blood (+) and primary gastric tumor without surgery should be carried out gastroscopy, patients with ulcero carcinoma of stomach and believed to cause the lesion to bleed by the physician;
•Abnormal coagulation function(INR\>1.5×ULN、 APTT\>1.5×ULN) with bleeding tendency;
•With Symptomatic central nervous system metastasis;
•Pregnant or lactating women;
•Other patients unsuitable for inclusion considered by the physician.