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

NCT03702491 | Unknown Phase 2

• 1 other identifier: XJiang
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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

Conditions

Gallbladder Carcinoma

Outcome Measures

Primary Outcomes (1)

• PFS

  progression-free survival

  12 month after first treatment

Study Arms (2)

Apatinib with SOX(Tegafur,Oxaliplatin)

EXPERIMENTAL

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

SOX( Tegafur,Oxaliplatin)

ACTIVE COMPARATOR

3-4 weeks after operation, 6-8 cycles of adjuvant chemotherapy with simple SOX protocol were given.

Drug: Tegafur

Interventions

Apatinib DRUG

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

Also known as: Tegafur, Oxaliplatin

Apatinib with SOX(Tegafur,Oxaliplatin)

Tegafur DRUG

3-4 weeks after operation, 6-8 cycles of adjuvant chemotherapy with simple SOX protocol were given.

Also known as: Oxaliplatin

SOX( Tegafur,Oxaliplatin)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ages 18 to 75
• 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;
• The primary treatment is surgical resection or potentially resectable cholecystic carcinoma without other treatment
• ECOG performance status ≤1
• 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）;
• 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;
• Estimated life expectancy \> 3 months.
• 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.
• Patient able and willing to provide written informed consent and to comply with the study protocol and Good compliance, with follow-up.

You may not qualify if:

• 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

Sponsors & Collaborators

• Eastern Hepatobiliary Surgery Hospital: lead

Study Sites (1)

xiao qing xiao qing Jiang

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Gallbladder Neoplasms

Interventions

apatinib; Tegafur; Oxaliplatin

Condition Hierarchy (Ancestors)

Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases

Intervention Hierarchy (Ancestors)

Fluorouracil; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Coordination Complexes; Organic Chemicals

Study Officials

• xiao qing Jiang, professor

  700 Moyu Road North, Jiading District,Eastern Hepatobiliary Surgery Hospital, Shanghai, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

xiao qing Jiang, professor

CONTACT

13801603438; Jxq1225@sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Chief Physician

Study Record Dates

• First Submitted: October 7, 2018
• First Posted: October 11, 2018
• Study Start: August 10, 2018
• Primary Completion: August 10, 2020
• Study Completion: August 10, 2020
• Last Updated: October 11, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)