Back to resultsTreatment of Advanced Gastrointestinal Tumors With Albumin Taxol
Primary Purpose
Advanced Gastrointestinal Tumors
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Albumin binding taxol
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Gastrointestinal Tumors
Eligibility Criteria
Inclusion Criteria:
- Patients aged ≥18 years with advanced esophageal cancer, gastric cancer, pancreatic cancer and gallbladder (duct) confirmed histologically by albumin paclitaxel chemotherapy regimen;
- ECOG PS 0-2；
- Expected survival time ≥3 months;
- According to RECIST1.1, at least one measurable lesion exists；
- The level of organ function must meet the following requirements（1）Blood routine examination standards must be met：HB≥90 g/L；ANC≥1.5×109/L； PLT≥80×109/L；（2）Liver function should meet the following criteria TBIL≤1.5×ULN；AST≤2.5×ULN；（3）Renal function should meet the following criteria: CrCL≥60 ml/min；
Exclusion Criteria:
- Pregnant or lactating women；
- Had a history of other primary malignancies within 5 years, with the exception of cured basal cell skin cancer and cured cervical cancer;
- Active brain metastasis or severe disease;
- Grade 1 peripheral neuropathy (judged according to NCICTC standard for adverse reactions);
- Patients with allergy to research drugs, albumin or previous allergies;
- Severe mental or neurological disorders affecting the presentation or observation of adverse reactions;
- The investigator considers that there is any condition that may impair the subject or cause the subject to fail to meet or perform the study requirements.
Sites / Locations
- Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Albumin binding taxol
Arm Description
Outcomes
Primary Outcome Measures
Progression free survival (PFS)
Progression free survival (PFS) is the time between the onset of treatment and the observation of disease progression or death from any cause.
Secondary Outcome Measures
Objective remission rate (ORR)
Defined as the proportion of patients with a documented complete response, and partial response (CR+PR)
Overall survival
The Overall survival (OS) is defined as the date from random grouping to death from any cause.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03977077
Brief Title
Treatment of Advanced Gastrointestinal Tumors With Albumin Taxol
Official Title
A Retrospective Clinical Study on the Efficacy and Safety of Injection Taxol (Albumin Binding Type) in the Treatment of Patients With Advanced Gastrointestinal Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2019 (Anticipated)
Primary Completion Date
October 31, 2019 (Anticipated)
Study Completion Date
October 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Henan Cancer Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study was to evaluate the safety and efficacy of domestic injection paclitaxel (albumin binding type) in patients with advanced digestive tract tumors,and to further explore the possible predictors of efficacy.In order to provide more effective chemotherapeutic drugs, prolong survival time and improve quality of life for patients with advanced digestive tract tumors.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Gastrointestinal Tumors
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Albumin binding taxol
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Albumin binding taxol
Intervention Description
125mg/m2, d1, 8, intravenous infusion for 30min, 1 cycle every 3 weeks;Other combined chemotherapy drugs and drug doses shall be administered by clinicians according to the guidelines and the actual situation of clinical patients.
Primary Outcome Measure Information:
Title
Progression free survival (PFS)
Description
Progression free survival (PFS) is the time between the onset of treatment and the observation of disease progression or death from any cause.
Time Frame
up to 2 year
Secondary Outcome Measure Information:
Title
Objective remission rate (ORR)
Description
Defined as the proportion of patients with a documented complete response, and partial response (CR+PR)
Time Frame
up to 2 year
Title
Overall survival
Description
The Overall survival (OS) is defined as the date from random grouping to death from any cause.
Time Frame
up to 2 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aged ≥18 years with advanced esophageal cancer, gastric cancer, pancreatic cancer and gallbladder (duct) confirmed histologically by albumin paclitaxel chemotherapy regimen;
ECOG PS 0-2；
Expected survival time ≥3 months;
According to RECIST1.1, at least one measurable lesion exists；
The level of organ function must meet the following requirements（1）Blood routine examination standards must be met：HB≥90 g/L；ANC≥1.5×109/L； PLT≥80×109/L；（2）Liver function should meet the following criteria TBIL≤1.5×ULN；AST≤2.5×ULN；（3）Renal function should meet the following criteria: CrCL≥60 ml/min；
Exclusion Criteria:
Pregnant or lactating women；
Had a history of other primary malignancies within 5 years, with the exception of cured basal cell skin cancer and cured cervical cancer;
Active brain metastasis or severe disease;
Grade 1 peripheral neuropathy (judged according to NCICTC standard for adverse reactions);
Patients with allergy to research drugs, albumin or previous allergies;
Severe mental or neurological disorders affecting the presentation or observation of adverse reactions;
The investigator considers that there is any condition that may impair the subject or cause the subject to fail to meet or perform the study requirements.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xifang Hou
Phone
15136130286
Email
houxinfang2013@163.com
Facility Information:
Facility Name
Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
12. IPD Sharing Statement
Learn more about this trial
Treatment of Advanced Gastrointestinal Tumors With Albumin Taxol
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