Apatinib as first-line therapy for elderly with advanced or metastatic gastric cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 2 interventional trial evaluating the efficacy and safety of apatinib given orally at 500 mg daily (potentially reduced to 250 mg for adverse events) as first-line treatment in patients aged 65 and older with locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma who are unsuitable for chemotherapy. Eligibility includes measurable disease, good organ function, and ECOG 0-2. Treatment continues until progression, intolerable toxicity, or withdrawal, with tumor samples collected for NGS analysis prior to starting therapy. Response assessments (SD/PR/CR) guide continuation every two cycles. Target enrollment is about 30 patients, with tumor biomarker data intended to inform responses.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients with histologically proven primary locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma;
2. Age ≥ 65 years;
3. ECOG Performance Status: 0-2;
4. No previous anti-cancer therapy for the locally advanced or metastatic disease;
5. Unable or unwilling to chemotherapy;
6. At least one measurable lesion as defined by RECIST 1.1;
7. With acceptable hematologic, cardiac, hepatic, pulmonary and renal function;
8. Can take apatinib orally;
9. Life Expectancy: 3 months or more.

Exclusion Criteria:

1. History of other primary malignancy (except basal cell skin cancer or cervical carcinoma in situ);
2. Patients with un-controlled blood pressure on medication (\> 140/90 mmHg);
3. Patients with other nonmeasurable disease such as un-controlled diabetes, severe cardiovascular and cerebrovascular diseases;
4. Patients with bleeding tendency, receiving thrombolytics or anticoagulants；
5. Patients with massive hydrothorax or ascites;
6. Patients with uncontrolled central nervous system (CNS) metastases;
7. Proteinuria 2+ or 24-hour urinary protein ≥ 1g;
8. History of drug addiction or abuse;
9. Patients cannot take apatinib orally for any reason;
10. Estimated life expectancy ˂ 3 months;
11. Current, recent (within 4 weeks prior to study entry), or planned participation in any other clinical trials;
12. Inability to understand and agree to informed consent.

Where it's running

• Department of Medical Oncology, First Affiliated Hospital of Bengbu Medical College
  Bengbu, Anhui, China Recruiting

Study contacts

• Principal investigator: Qiong Wu, M.D.,Ph.D — The First Affiliated Hospital of Bengbu Medical University
• Study coordinator: Yan Yang, M.D.,Ph.D
• Email: qiannianhupo@163.com
• Phone: +86-552-3086178

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.