Treatment of Advanced Gastrointestinal Tumors With Albumin Taxol

Advanced Gastrointestinal Tumors Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03977077
• Other study ID #: AYGAS-0531
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: October 31, 2020

Study information

• Verified date: May 2019
• Source: Henan Cancer Hospital
• Contact: Xifang Hou
• Phone: 15136130286
• Email: houxinfang2013[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: October 31, 2020
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Gastrointestinal Tumors
• Digestive System Neoplasms
• Gastrointestinal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Henan Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

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