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Apapitatin Combined With SOX for Palliative Adjuvant Chemotherapy in Patients With Advanced Gallbladder Carcinoma

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ClinicalTrials.gov Identifier: NCT03702491
Recruitment Status : Recruiting
First Posted : October 11, 2018
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Xiaoqing Jiang, 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

Condition or disease Intervention/treatment Phase
Gallbladder Carcinoma Drug: Apatinib Drug: Tegafur 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-center Open, Randomized, Controlled Study to Compare the Apapitatin Combined With SOX and SOX for Palliative Adjuvant Chemotherapy in Patients With Advanced Gallbladder Carcinoma
Actual Study Start Date : August 10, 2018
Estimated Primary Completion Date : August 10, 2020
Estimated Study Completion Date : August 10, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Oxaliplatin

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:
  • Tegafur
  • Oxaliplatin

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 Name: Oxaliplatin




Primary Outcome Measures :
  1. PFS [ Time Frame: 12 month after first treatment ]
    progression-free survival



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. ages 18 to 75
  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:

  1. Non gallbladder carcinoma
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03702491


Contacts
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Contact: xiao qing Jiang, professor 13801603438 ext 13801603438 Jxq1225@sina.com

Locations
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China, Shanghai
xiao qing xiao qing Jiang Recruiting
Shanghai, Shanghai, China
Contact: xiao q xiao qing Jiang    13801603438 ext 13801603438    Jxq1225@sina.com   
Sponsors and Collaborators
Eastern Hepatobiliary Surgery Hospital
Investigators
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Principal Investigator: xiao qing Jiang, professor 700 Moyu Road North, Jiading District,Eastern Hepatobiliary Surgery Hospital, Shanghai, China

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Responsible Party: Xiaoqing Jiang, Professor Chief Physician, Eastern Hepatobiliary Surgery Hospital
ClinicalTrials.gov Identifier: NCT03702491     History of Changes
Other Study ID Numbers: XJiang
First Posted: October 11, 2018    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Carcinoma
Gallbladder Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Oxaliplatin
Apatinib
Tegafur
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites