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Treatment of Advanced Gastrointestinal Tumors With Albumin Taxol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03977077
Recruitment Status : Not yet recruiting
First Posted : June 6, 2019
Last Update Posted : June 6, 2019
Sponsor:
Information provided by (Responsible Party):
Henan Cancer Hospital

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

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.




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.



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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.

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): NCT03977077


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

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Responsible Party: Henan Cancer Hospital
ClinicalTrials.gov Identifier: NCT03977077     History of Changes
Other Study ID Numbers: AYGAS-0531
First Posted: June 6, 2019    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: May 2019

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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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Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Neoplasms
Neoplasms by Site
Neoplasms
Gastrointestinal Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action