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

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

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

Study Overview

• Status: Unknown
• Conditions: Gallbladder Carcinoma
• Intervention / Treatment: Drug: Apatinib; Drug: Tegafur

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 Type: Interventional
• Enrollment (Anticipated): 138
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: xiao qing Jiang, professor; Phone Number: 13801603438 13801603438; Email: Jxq1225@sina.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • xiao qing xiao qing Jiang
      • Contact: xiao q xiao qing Jiang; Phone Number: 13801603438 13801603438; Email: Jxq1225@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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: Oxaliplatin; Tegafur
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: Oxaliplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	progression-free survival	12 month after first treatment

Collaborators and Investigators

• Sponsor: Eastern Hepatobiliary Surgery Hospital
• Investigators: Principal Investigator: xiao qing Jiang, professor, 700 Moyu Road North, Jiading District,Eastern Hepatobiliary Surgery Hospital, Shanghai, China

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2018
• Primary Completion (Anticipated): August 10, 2020
• Study Completion (Anticipated): August 10, 2020

Study Registration Dates

• First Submitted: October 7, 2018
• First Submitted That Met QC Criteria: October 9, 2018
• First Posted (Actual): October 11, 2018

Study Record Updates

• Last Update Posted (Actual): October 11, 2018
• Last Update Submitted That Met QC Criteria: October 9, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Gallbladder Diseases; Biliary Tract Diseases; Biliary Tract Neoplasms; Carcinoma; Gallbladder Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Protein Kinase Inhibitors; Oxaliplatin; Apatinib; Tegafur
• Other Study ID Numbers: XJiang

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No