NCT03219593RecruitingPhase 2
Apatinib as the First-Line Therapy in Elderly Locally Advanced or Metastatic Gastric Cancer
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
Source: ClinicalTrials.gov · Last updated 8 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 13 Jul 2017
- Start date
- 7 Sept 2017
- Primary completion date
- 31 Aug 2027
- Lead sponsor
- The First Affiliated Hospital of Bengbu Medical University
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT03219593
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 30
- From 7 Sept 2017 to the primary completion date, 31 Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with un-controlled blood pressure on medication (\> 140/90 mmHg);
- Patients with bleeding tendency, receiving thrombolytics or anticoagulants；
- Current, recent (within 4 weeks prior to study entry), or planned participation in any other clinical trials;
Other illness
- History of other primary malignancy (except basal cell skin cancer or cervical carcinoma in situ);
- Patients with other nonmeasurable disease such as un-controlled diabetes, severe cardiovascular and cerebrovascular diseases;
- History of drug addiction or abuse;
Other
- Patients with massive hydrothorax or ascites;
- Patients with uncontrolled central nervous system (CNS) metastases;
- Proteinuria 2+ or 24-hour urinary protein ≥ 1g;
- Patients cannot take apatinib orally for any reason;
- Estimated life expectancy ˂ 3 months;
- Inability to understand and agree to informed consent.
Who the study is looking for
- 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;
- Unable or unwilling to chemotherapy;
- At least one measurable lesion as defined by RECIST 1.1;
- With acceptable hematologic, cardiac, hepatic, pulmonary and renal function;
- Can take apatinib orally;
- Life Expectancy: 3 months or more.
Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Medical Oncology, First Affiliated Hospital of Bengbu Medical College Coordinator of this site? Confirm its status | Bengbu | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.