Gastric Cancer
Conditions
Keywords
gastric cancer, gastroesophageal junction cancer, Apatinib, S1
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.
Interventions
DRUGApatinib
Apatinib,500mg,qd,po,d1-21;S1,40mg,bid,d1-14;every 21days a cycle
Sponsors
Beijing Friendship Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Adult patients, aged between 18 and 75 years old; 2. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2; 3. 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; 4. Failure or intolerance to at least one prior line of systemic chemotherapy regimen; 5. Adequate liver, renal, heart, and bone-marrow functions ( hemoglobin≥ 80g/L, platelets ≥ 100 × 10\*9/L, neutrophil ≥1.5 × 10\*9/L, total bilirubin ≤1.5 ×ULN, and serum transaminase≤2.5×ULN); 6. Expected survival of ≥ 12 weeks.
Exclusion criteria
1. 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; 2. 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; 3. Abnormal Coagulation (INR\>1.5、APTT\>1.5 UNL), with tendency of bleed; 4. Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction); 5. Previous treatment with VEGFR inhibitor (i.e. Apatinib, sorafenib, sunitinib); 6. With psychotropic drug abuse history and can't get rid of or mental disorder patients; 7. Associated with CNS (central nervous system) metastases; 8. Active bacterial infections; 9. Pregnant or breast-feeding women; 10. Any other condition that might place the patient at undue risk or preclude a patient from completing the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
China
Contacts
Primary ContactWei Deng, M.D.
Backup ContactZhigang Bai, M.D.
Outcome results
None listed