- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02697838
Clinical Trial of Apatinib Reverses Chemotherapy-Resistance of Patients With Advanced Gastric Cancer
October 13, 2018 updated by: Fujian Cancer Hospital
A single arm study: Apatinib plus paclitaxel as the reverses treatment in advanced gastric cancer which paclitaxel-resistant.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
This trial investigated the efficacy and safety of apatinib plus paclitaxel, as a treatment option for patients with advanced gastric cancer which paclitaxel-resistant.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Fujian
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Fuzhou, Fujian, China, 350014
- Rongbo Lin
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age: more than 18 years old;
- Histologically confirmed advanced or metastatic adenocarcinoma of gastric cancer(AGC) , including adenocarcinoma of the gastroesophageal junction;
- At least one measurable and evaluable disease based on response evaluation criteria in solid tumors (RECIST v1.1);
- The patient with Prior Paclitaxel-Resistant;
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2;
- An expected survival of ≥ 3 months;
- Duration from the last therapy is more than 6 weeks for nitroso or mitomycin, More than 4 weeks for other cytotoxic agents, operation or radiotherapy;
Major organ function has to meet the following criteria; (1) For results of blood routine test:
- Hemoglobin (HB) ≥ 80g / L,
- ANC ≥ 1.5 × 109 / L,
- PLT ≥ 75 × 109 / L, (2) For results of biochemical tests:
- BLT ≤ 1.25 times the upper limit of normal (ULN),
- ALT and AST ≤ 2.5 × ULN, liver metastases, if any, the ALT and AST≤ 5 × ULN,
- Serum Cr≤1ULN, Endogenous creatinine clearance rate >50ml/min;
- Pregnancy test (serum or urine) has to be performed for woman of childbearing age within 7 days before enrolment and the test result must be negative. They shall take appropriate methods for contraception during the study until the 8th week post the last administration of study drug. For men, (previous surgical sterilization accepted), shall agree to take appropriate methods of contraception during the study until the 8th week post the last administration of study drug;
- Patient has to voluntarily join the study and sign the Informed Consent Form for the study.
Exclusion Criteria:
- History of other malignancies except cured basal cell carcinoma of skin and carcinoma insitu of uterine cervix;
- Confirmed that apatinib and/or its accessories allergy;
- Subjects with poor-controlled arterial hypertension (systolic blood pressure> 140 mmHg and diastolic blood pressure > 90 mm Hg) despite standard medical management;
- Serious cardiovascular disease: Ⅱ-level myocardial ischemia or myocardial infarction, arrhythmia (including QT interval prolongation, for man ≥ 450 ms, for woman ≥ 470 ms); III ~ IV level cardiac function insufficiency, or echocardiography showed that left ventricular ejection fraction (LVEF < 50%);
- Patients with positive urinary protein (urine protein detection of 2 or more, or 24 hour urine protein >1.0g);
- Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);
- Subjects with high gastrointestinal bleeding risk, including the following conditions: local active ulcer lesions with positive fecal occult blood test (++); history of black stool, or vomiting blood in the past 2 months;unresected primary lesion in stomach with positive fecal occult blood test (+), ulcerated gastric carcinoma with massive alimentary tract bleeding risk judged by PIs based on gastric endoscopy result;
- Abnormal Coagulation (INR>1.5、APTT>1.5 UNL), with tendency of bleed;
- With psychotropic drug abuse history and can't get rid or with mental disorder patients;
- Less than 4 weeks from the last clinical trial;
- According to the researcher's judgment, with other serious diseases which harm to patient safety or affect patients complete the study;
- Evidence of central nervous system(CNS) metastasis;
- Pregnant or lactating women;
- Other conditions regimented at investigators' discretion.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental: Apatinib plus chemotherapy
|
Apatinib (850 mg qd p.o.) until disease progression or intolerable toxicity or refused by the patients.
Paclitaxel-based chemotherapeutic regimens including:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
disease control rate(DCR)
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2016
Primary Completion (Actual)
March 31, 2018
Study Completion (Anticipated)
October 31, 2018
Study Registration Dates
First Submitted
February 25, 2016
First Submitted That Met QC Criteria
February 28, 2016
First Posted (Estimate)
March 3, 2016
Study Record Updates
Last Update Posted (Actual)
October 17, 2018
Last Update Submitted That Met QC Criteria
October 13, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Neoplasms
- Stomach Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Protein Kinase Inhibitors
- Paclitaxel
- Apatinib
Other Study ID Numbers
- AHEAD-G323
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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