Apapitatin Combined With SOX for Palliative Adjuvant Chemotherapy in Patients With Advanced Gallbladder Carcinoma
NCT ID: NCT03702491
Last Updated: 2018-10-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
138 participants
INTERVENTIONAL
2018-08-10
2020-08-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
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
SOX( Tegafur,Oxaliplatin)
3-4 weeks after operation, 6-8 cycles of adjuvant chemotherapy with simple SOX protocol were given.
Tegafur
3-4 weeks after operation, 6-8 cycles of adjuvant chemotherapy with simple SOX protocol were given.
Interventions
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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
Tegafur
3-4 weeks after operation, 6-8 cycles of adjuvant chemotherapy with simple SOX protocol were given.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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;
3. The primary treatment is surgical resection or potentially resectable cholecystic carcinoma without other treatment
4. ECOG performance status ≤1
5. 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）;
6. 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;
7. Estimated life expectancy \> 3 months.
8. 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.
9. Patient able and willing to provide written informed consent and to comply with the study protocol and Good compliance, with follow-up.
Exclusion Criteria
2. 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.
3. Other topical treatments during the study (including intraperitoneal chemotherapy, radiotherapy, etc.)
4. Pregnant or lactating women；
5. Those who suffer from high blood pressure and cannot be treated to the normal range by antihypertensive drugs；
6. HIV infection or the presence of AIDS-related diseases, or severe acute and chronic diseases;
7. Have grade II or higher myocardial ischemia or myocardial infarction、Poorly controlled arrhythmia；
8. Severe active infections；
9. 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.
10. Researchers believe that their compliance is poor
11. There are contraindications for Apatinib and S-1
18 Years
75 Years
ALL
No
Sponsors
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Eastern Hepatobiliary Surgery Hospital
OTHER
Responsible Party
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Xiaoqing Jiang
Professor Chief Physician
Principal Investigators
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xiao qing Jiang, professor
Role: PRINCIPAL_INVESTIGATOR
700 Moyu Road North, Jiading District,Eastern Hepatobiliary Surgery Hospital, Shanghai, China
Locations
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xiao qing xiao qing Jiang
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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XJiang
Identifier Type: -
Identifier Source: org_study_id
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