Apatinib as the First-Line Therapy in Elderly Locally Advanced or Metastatic Gastric Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age65+
SponsorThe First Affiliated Hospital of Bengbu Medical University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with histologically proven primary locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma;
Age ≥ 65 years;
ECOG Performance Status: 0-2;
No previous anti-cancer therapy for the locally advanced or metastatic disease;
Disqualifiers
History of other primary malignancy (except basal cell skin cancer or cervical carcinoma in situ);
Patients with un-controlled blood pressure on medication (> 140/90 mmHg);
Patients with other nonmeasurable disease such as un-controlled diabetes, severe cardiovascular and cerebrovascular diseases;
Patients with bleeding tendency, receiving thrombolytics or anticoagulants；
Trial design
Design model
Single group
Treatments tested in this trial
Apatinib mesylate tablets
DrugApatinib 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Apatinib GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Progression-free survival (PFS)
PFS was defined to be the time from registration to the date of disease progression or death resulting from any cause.
Time frame
1 yearSecondary outcomes
1
Overall survival (OS)
OS was defined to be the time from registration to the date of death resulting from any cause or the last contact.
Time frame
2 years2
Disease control rate (DCR)
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 year3
Objective response rate (ORR)
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 year4
Quality of life score (QoL)
QoL is a questionnaire developed to assess the quality of life of cancer patients.
Time frame
1 yearOther outcomes
1
Tumor biomarkers
Tumor tissue samples will be applied to next generation sequencing (NGS) detection to reveal any gene variation through comprehensive genomic profiling.
Time frame
Before the start of apatinib treatmentSponsors and contacts
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Source ClinicalTrials.gov