Apapitatin Combined With SOX for Palliative Adjuvant Chemotherapy in Patients With Advanced Gallbladder Carcinoma
- Registration Number
- NCT03702491
- Lead Sponsor
- Eastern Hepatobiliary Surgery Hospital
- 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
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 138
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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.
- Non gallbladder carcinoma
- 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.
- Other topical treatments during the study (including intraperitoneal chemotherapy, radiotherapy, etc.)
- Pregnant or lactating women；
- Those who suffer from high blood pressure and cannot be treated to the normal range by antihypertensive drugs；
- HIV infection or the presence of AIDS-related diseases, or severe acute and chronic diseases;
- Have grade II or higher myocardial ischemia or myocardial infarction、Poorly controlled arrhythmia；
- Severe active infections；
- 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.
- Researchers believe that their compliance is poor
- There are contraindications for Apatinib and S-1
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Apatinib with SOX(Tegafur,Oxaliplatin) Apatinib 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 SOX( Tegafur,Oxaliplatin) Tegafur 3-4 weeks after operation, 6-8 cycles of adjuvant chemotherapy with simple SOX protocol were given.
- Primary Outcome Measures
Name Time Method PFS 12 month after first treatment progression-free survival
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
xiao qing xiao qing Jiang
🇨🇳Shanghai, Shanghai, China