A Study of Apatinib Combined With S1 in Patients With Advanced Gastric Cancer
Study Details
Study Description
Brief Summary
Antiangiogenesis therapy plays an important role in cancer treatment. Apatinib showed good safety and efficacy as third-line therapy for advanced gastric cancer.We conducted this trial to investigate the safety and efficacy of apatinib combined with S1 after failure of first-line chemotherapy in advanced gastric cancer or gastroesophageal junction carcinoma patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Apatinib plus S1 patients with advanced gastric cancer enrolled after failure of first-line systemic chemotherapy will be given Apatinib plus S1 till progressive disease,death or non-tolerable toxicity |
Drug: Apatinib
Apatinib,500mg,qd,po,d1-21;S1,40mg,bid,d1-14;every 21days a cycle
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Progression-free survival (PFS) [Approximately 1 year]
defined as the time from randomize to progression or death; RECIST guidelines were used to define all responses after patients had received every 6 weeks of therapy
Secondary Outcome Measures
- Overall survival (OS) [Approximately 2 years]
defined as the time from randomize to death
- Safety (incidence of adverse events) [Approximately 1 year]
incidence of adverse events
- Quality of life(QoL) [Approximately 2 years]
as measured by the European Organization for Research and Treatment of Cancer questionnaire (EORTC QLQ C30)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adult patients, aged between 18 and 75 years old;
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Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2;
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Histologically confirmed advanced or metastatic adenocarcinoma of gastric cancer(AGC) , including adenocarcinoma of the gastroesophageal junction ,one or more measurable or nonmeasurable evaluable lesions per RECIST 1.1;
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Failure or intolerance to at least one prior line of systemic chemotherapy regimen;
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Adequate liver, renal, heart, and bone-marrow functions ( hemoglobin≥ 80g/L, platelets ≥ 100 × 109/L, neutrophil ≥1.5 × 109/L, total bilirubin ≤1.5 ×ULN, and serum transaminase≤2.5×ULN);
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Expected survival of ≥ 12 weeks.
Exclusion Criteria:
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Subjects with poor-controlled arterial hypertension (systolic blood pressure> 140 mmHg and diastolic blood pressure > 90 mm Hg) despite standard medical management; Coronary heart disease greater than ClassI; I-level arrhythmia (including QT interval prolongation, for man ≥ 450 ms, for woman ≥ 470 ms) together with Class I cardiac dysfunction;
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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;
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Abnormal Coagulation (INR>1.5、APTT>1.5 UNL), with tendency of bleed;
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Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);
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Previous treatment with VEGFR inhibitor (i.e. Apatinib, sorafenib, sunitinib);
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With psychotropic drug abuse history and can't get rid of or mental disorder patients;
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Associated with CNS (central nervous system) metastases;
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Active bacterial infections;
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Pregnant or breast-feeding women;
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Any other condition that might place the patient at undue risk or preclude a patient from completing the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beijing Friendship Hospital | Beijing | Beijing | China | 100050 |
Sponsors and Collaborators
- Beijing Friendship Hospital
Investigators
- Principal Investigator: Wei Deng, M.D., Beijing Friendship Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AHEAD-Y001