XELOX Combined With Apatinib as Post-operative Chemotherapy in Locally Advanced Gastric Adenocarcinoma
Study Details
Study Description
Brief Summary
To observe and evaluate the efficacy and safety of oxaliplatin with oapecitabine(XELOX)combined with apatinib as post-operative chemotherapy in locally advanced gastric adenocarcinoma with D2 dissection
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1/Phase 2 |
Detailed Description
Stage 1 (phase I tolerance study) : 12 patients were enrolled in the dose-climbing study:According to the principle of dose-climbing test,todetermine the subjects' MTD, with the following three dose levels:
- Capecitabine: 1000 mg/m2 bid d1-14 q3w, oxaliplatin: 130 mg/m2 d1 q3w) + apatinib 250 mg, qd x180d; ②. Capecitabine: 1000 mg/m2 bid d1-14 q3w, oxaliplatin: 130 mg/m2 d1 q3w)
- apatinib 375 mg, qd x180d; ③. Capecitabine: 1000 mg/m2 bid d1-14 q3w, oxaliplatin: 130 mg/m2 d1 q3w) + apatinib 500 mg, qd x180d;
Stage 2 (phase II exploratory study) :
①.Test group: subjects received 8 cycles of postoperative XELOX regimen (capecitabine: 1000 mg/m2 bid d1-14 q3w, oxaliplatin: 130 mg/m2 d1 q3w) + apatinib maximum tolerated dose
②.Control group: Subjects received 8 cycles of XELOX regimen after surgery (capecitabine: 1000 mg/m2 bid d1-14 q3w, oxaliplatin: 130 mg/m2 d1 q3w).
Eligible patients will receive 8 cycles of postoperative adjuvant therapy and will be followed up to death
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: treatment group 8 cycles of postoperative XELOX regimen (capecitabine: 1000 mg/m2 bid d1-14 q3w, oxaliplatin: 130 mg/m2 d1 q3w) + apatinib'MTD(maximum tolerated dose) |
Drug: Apatinib
XELOX + apatinib's MTD
Other Names:
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Active Comparator: Control group 8 cycles of postoperative XELOX regimen (capecitabine: 1000 mg/m2 bid d1-14 q3w, oxaliplatin: 130 mg/m2 d1 q3w) |
Drug: Apatinib
XELOX + apatinib's MTD
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Disease-free survival (DFS) [3 months]
Disease-free survival (DFS) is defined as the time from the beginning of treatment to Disease recurrence or death due to Disease progression
Eligibility Criteria
Criteria
Inclusion Criteria:
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ECOG score is 0-1;
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Radical gastrectomy (D2, R0) for gastric cancer has been performed (more than 16 lymph nodes have been detected);
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Postoperative histology confirmed gastric adenocarcinoma;
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The pathological stage of gastric cancer is ⅢA-ⅢC stage (8th AJCC TNM);
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Subjects' baseline blood routine and biochemical indicators meet the following standards:
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ANC≥1.5×109/L;
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Hb≥90g/L;
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PLT≥100×109/L;
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TBIL≤1.5×ULN;
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ALT and AST≤2×ULN;
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Cr≤1.5×ULN
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INR:1.0~1.5; APTT is within the normal range
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The electrocardiogram was basically normal before the first 4 weeks after admission, and there were no obvious clinical symptoms of heart disease;
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Sign informed consent.
Exclusion Criteria:
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Patients with severe hypertension and poor drug control;
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Various factors that affect oral drugs such as (inability to swallow, complete or incomplete gastrointestinal obstruction, active gastrointestinal bleeding, perforation ) ;
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Patients with previous bradycardia or prolonged QT interval;
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Patients with postoperative gastrointestinal fistula and wound rupture;
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Known allergy to capecitabine or oxaliplatin, or metabolic disorder;
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Patients receiving preoperative chemotherapy, radiotherapy or targeted therapy before;
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Patients Using other experimental drugs at the same time or joining in other clinical trials.
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Patients with severe liver diseases (such as liver cirrhosis), nephropathy, respiratory diseases or chronic systemic diseases such as uncontrollable diabetes and hypertension; Clinical symptoms of heart disease,such as congestive heart failure,coronary heart disease symptoms, arrhythmia, hypertension,that hard to control,or having myocardial infarction attack in six months or cardiac insufficiency.
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Patients with peripheral nervous system disorder or with a history of significant psychiatric disorder and central nervous system disorder;
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Anhui Provincial Cancer Hospital | Hefei | Anhui | China | 230000 |
Sponsors and Collaborators
- Anhui Provincial Hospital
Investigators
- Principal Investigator: Xinyang He, master, Anhui Provincial Cancer Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AHTH-201