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出境医 / 临床实验 / Treatment of Advanced Gastrointestinal Tumors With Albumin Taxol

Treatment of Advanced Gastrointestinal Tumors With Albumin Taxol

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.

Condition or disease Intervention/treatment Phase
Advanced Gastrointestinal Tumors Drug: Albumin binding taxol Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : October 31, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: Albumin binding taxol Drug: Albumin binding taxol
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.
Outcome Measures
Primary Outcome Measures :
  1. Progression free survival (PFS) [ Time Frame: up to 2 year ]
    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 :
  1. Objective remission rate (ORR) [ Time Frame: up to 2 year ]
    Defined as the proportion of patients with a documented complete response, and partial response (CR+PR)

  2. Overall survival [ Time Frame: up to 2 year ]
    The Overall survival (OS) is defined as the date from random grouping to death from any cause.


Eligibility Criteria
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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. Patients aged ≥18 years with advanced esophageal cancer, gastric cancer, pancreatic cancer and gallbladder (duct) confirmed histologically by albumin paclitaxel chemotherapy regimen;
  2. ECOG PS 0-2；
  3. Expected survival time ≥3 months;
  4. According to RECIST1.1, at least one measurable lesion exists；
  5. 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:

  1. Pregnant or lactating women；
  2. Had a history of other primary malignancies within 5 years, with the exception of cured basal cell skin cancer and cured cervical cancer;
  3. Active brain metastasis or severe disease;
  4. Grade 1 peripheral neuropathy (judged according to NCICTC standard for adverse reactions);
  5. Patients with allergy to research drugs, albumin or previous allergies;
  6. Severe mental or neurological disorders affecting the presentation or observation of adverse reactions;
  7. 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.
Contacts and Locations

Contacts
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Contact: Xifang Hou 15136130286 houxinfang2013@163.com

Locations
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China, Henan
Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
Zhengzhou, Henan, China, 450008
Sponsors and Collaborators
Henan Cancer Hospital
Tracking Information
First Submitted Date  ICMJE June 3, 2019
First Posted Date  ICMJE June 6, 2019
Last Update Posted Date June 6, 2019
Estimated Study Start Date  ICMJE June 1, 2019
Estimated Primary Completion Date October 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2019) 		Progression free survival (PFS) [ Time Frame: up to 2 year ]
Progression free survival (PFS) is the time between the onset of treatment and the observation of disease progression or death from any cause.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2019)
  • Objective remission rate (ORR) [ Time Frame: up to 2 year ]
    Defined as the proportion of patients with a documented complete response, and partial response (CR+PR)
  • Overall survival [ Time Frame: up to 2 year ]
    The Overall survival (OS) is defined as the date from random grouping to death from any cause.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Advanced Gastrointestinal Tumors With Albumin Taxol
Official Title  ICMJE A Retrospective Clinical Study on the Efficacy and Safety of Injection Taxol (Albumin Binding Type) in the Treatment of Patients With Advanced Gastrointestinal Tumors
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Gastrointestinal Tumors
Intervention  ICMJE Drug: Albumin binding taxol
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.
Study Arms  ICMJE Experimental: Albumin binding taxol
Intervention: Drug: Albumin binding taxol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 5, 2019) 		100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2020
Estimated Primary Completion Date October 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients aged ≥18 years with advanced esophageal cancer, gastric cancer, pancreatic cancer and gallbladder (duct) confirmed histologically by albumin paclitaxel chemotherapy regimen;
  2. ECOG PS 0-2；
  3. Expected survival time ≥3 months;
  4. According to RECIST1.1, at least one measurable lesion exists；
  5. 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:

  1. Pregnant or lactating women；
  2. Had a history of other primary malignancies within 5 years, with the exception of cured basal cell skin cancer and cured cervical cancer;
  3. Active brain metastasis or severe disease;
  4. Grade 1 peripheral neuropathy (judged according to NCICTC standard for adverse reactions);
  5. Patients with allergy to research drugs, albumin or previous allergies;
  6. Severe mental or neurological disorders affecting the presentation or observation of adverse reactions;
  7. 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03977077
Other Study ID Numbers  ICMJE AYGAS-0531
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Henan Cancer Hospital
Study Sponsor  ICMJE Henan Cancer Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Henan Cancer Hospital
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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