Treatment of Advanced Gastrointestinal Tumors With Albumin Taxol

Study Overview
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Brief Summary
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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.

Official Title
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A Retrospective Clinical Study on the Efficacy and Safety of Injection Taxol (Albumin Binding Type) in the Treatment of Patients With Advanced Gastrointestinal Tumors

Conditions
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Advanced Gastrointestinal Tumors

Intervention / Treatment
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* Drug: Albumin binding taxol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Albumin binding taxol<br> | Drug: Albumin binding taxol<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | up to 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective remission rate (ORR) | Defined as the proportion of patients with a documented complete response, and partial response (CR+PR) | up to 2 year | 
| Overall survival | The Overall survival (OS) is defined as the date from random grouping to death from any cause. | up to 2 year |