Apapitatin Combined With SOX for Palliative Adjuvant Chemotherapy in Patients With Advanced Gallbladder Carcinoma
Study Details
Study Description
Brief Summary
A Single-center Open, Randomized, Controlled Study to Compare the Apapitatin Mesylate Combined With SOX Regimen and SOX Regimen for Palliative Adjuvant Chemotherapy in Patients With Advanced Gallbladder Carcinoma
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Detailed Description
The aim of the study is to observe and evaluate the progression-free survival time (PFS), overall survival time (OS) and safety of patients with advanced Gallbladder Carcinoma treated with apatinib mesylate combined with SOX
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Apatinib with SOX(Tegafur,Oxaliplatin) Patients 3-4 weeks after surgery, the SOX regimen was given palliative adjuvant chemotherapy for 6-8 cycles, then followed by the second cycle combined with the treatment of apatinib mesylate and the monotherapy maintenance of apatinib mesylate |
Drug: Apatinib
Three to four weeks after surgery, the SOX regimen was given palliative adjuvant chemotherapy for 6-8 cycles, then followed by the second cycle combined with the treatment of apatinib mesylate and the monotherapy maintenance of apatinib mesylate
Other Names:
|
| Active Comparator: SOX( Tegafur,Oxaliplatin) 3-4 weeks after operation, 6-8 cycles of adjuvant chemotherapy with simple SOX protocol were given. |
Drug: Tegafur
3-4 weeks after operation, 6-8 cycles of adjuvant chemotherapy with simple SOX protocol were given.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- PFS [12 month after first treatment]
progression-free survival
Eligibility Criteria
Criteria
Inclusion Criteria:
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ages 18 to 75
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UICC/AJCC gallbladder TNM staging (The eighth edition), Ⅲ B - ⅣB (excluding M1) postoperative pathological diagnosis of gallbladder carcinoma;Patients confirmed to have undergone R1/R2 cholecystectomy or palliative surgery;
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The primary treatment is surgical resection or potentially resectable cholecystic carcinoma without other treatment
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ECOG performance status ≤1
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The liver and kidney function meets the following conditions： BIL<3 normal value upper limit (ULN)；ALT and AST< 2.5 xULN;Serum Cr≤ 1xULN,Clearance rate of endogenous creatinine>50ml/min（Cockcroft-Gault）;
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Other test rooms meet the following requirements:
Hemoglobin ≥ 90 g/L (no blood transfusion within 14 days)；Neutrophilic granulocyte count > 1.5x109 /L;The platelet count ≥ 80 x 10 ^ 9/L;
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Estimated life expectancy > 3 months.
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Before the enrollment, the heart function is good. There is no episode of myocardial infarction within half a year. For example, if you have hypertension or coronary heart disease, you should ensure that it is within the controllable range.
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Patient able and willing to provide written informed consent and to comply with the study protocol and Good compliance, with follow-up.
Exclusion Criteria:
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Non gallbladder carcinoma
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Significant clinical bleeding symptoms or a clear tendency to bleed occurred within the first month of randomization, such as cough/hemoptysis of 2.5ml or more, gastrointestinal bleeding, esophagogastric varices at risk of bleeding, hemorrhagic gastric ulcer, etc.
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Other topical treatments during the study (including intraperitoneal chemotherapy, radiotherapy, etc.)
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Pregnant or lactating women；
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Those who suffer from high blood pressure and cannot be treated to the normal range by antihypertensive drugs；
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HIV infection or the presence of AIDS-related diseases, or severe acute and chronic diseases;
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Have grade II or higher myocardial ischemia or myocardial infarction、Poorly controlled arrhythmia；
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Severe active infections；
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There are secondary malignant tumors or other tumors within 3 years before the start of the study and there is metastasis of the brain or meninges.
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Researchers believe that their compliance is poor
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There are contraindications for Apatinib and S-1
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | xiao qing xiao qing Jiang | Shanghai | Shanghai | China |
Sponsors and Collaborators
- Eastern Hepatobiliary Surgery Hospital
Investigators
- Principal Investigator: xiao qing Jiang, professor, 700 Moyu Road North, Jiading District,Eastern Hepatobiliary Surgery Hospital, Shanghai, China
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- XJiang