Department of Medical Oncology, First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233004, China
Location status: Recruiting
Location contact
Qiong Wu, M.D., Ph.D.
PRINCIPAL_INVESTIGATOR
Yan Yang, M.D., Ph.D.
CONTACT
NCT Number: NCT03219593
The study is to investigate the efficacy and safety of apatinib for the first-fine treatment in elderly patients with locally advanced or metastatic adenocarcinoma of stomach or gastroesophageal junction, unable or unwilling to chemotherapy, through progression-free survival (PFS). Apatinib will be given to patients with an efficacy assessment of stable disease (SD), partial response (PR), or complete response (CR) every 2 cycles. Patients were assigned to 500 mg/d apatinib continually until disease progression or intolerable toxicity or patients withdrawal of consent. The dose of apatinib may be decreased to 250 mg/d following the occurrence of a clinically significant adverse event (AE). Treatment will be discontinued if the subject is unable to tolerate a daily dose of 250 mg, and the sample size is about 30 individuals. Tumor tissue samples will be collected from each enrolled subjects before the start of treatment, and detected using next generation sequencing (NGS)-based comprehensive genomic profiling. The potential biomarkers in predicting apatinib efficacy or safety will be explored.
Interested in participating?
Request Info65 year and older
All sexes
Interventional
Phase 2
Bengbu, Anhui, 233004, China
Location status: Recruiting
Qiong Wu, M.D., Ph.D.
PRINCIPAL_INVESTIGATOR
Yan Yang, M.D., Ph.D.
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Apatinib is taken 500 mg every day orally, half hour after breakfast with warm water. The drug is taken 4 weeks one cycle until disease progression or intolerable toxicity or death. The dose of the study drug may be decreased to 250 mg/d following the occurrence of a clinically significant adverse event (AE). Treatment will be discontinued if the subject is unable to tolerate a daily dose of 250 mg.
Time frame: 1 year
PFS was defined to be the time from registration to the date of disease progression or death resulting from any cause.
Time frame: 2 years
OS was defined to be the time from registration to the date of death resulting from any cause or the last contact.
Time frame: 1 year
DCR was defined as the proportion of patients who achieved complete response (CR ), partial response (PR) and stable disease (SD) for at least 8 weeks.
Time frame: 1 year
ORR was defined as the proportion of eligible patients who achieved a confirmed CR or PR by RECIST 1.1 criteria evaluated by the investigators.
Time frame: 1 year
QoL is a questionnaire developed to assess the quality of life of cancer patients.
Time frame: 1 year
AEs are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v4.0.
Time frame: Before the start of apatinib treatment
Tumor tissue samples will be applied to next generation sequencing (NGS) detection to reveal any gene variation through comprehensive genomic profiling.
Contact information is provided by the study sponsor or research team.
The First Affiliated Hospital of Bengbu Medical University
Other
A Prospective Study of the Efficacy and Safety of Apatinib Monotherapy as First-Line Treatment in Elderly Patients With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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