Treatment of Advanced Gastrointestinal Tumors With Albumin Taxol

Not Applicable

• Conditions: Advanced Gastrointestinal Tumors
• Interventions: Drug: Albumin binding taxol

• Registration Number: NCT03977077
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-05
• Study Start: 2019-06-01
• Study First Submitted: 2019-06-03
• Study First Submitted QC: 2019-06-05
• Last Update Submitted: 2019-06-05
• Study First Posted: 2019-06-06
• Last Update Posted: 2019-06-06
• Primary Completion: 2019-10-31
• Study Completion: 2020-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Albumin binding taxol	Albumin binding taxol	-

Primary Outcome Measures

Name	Time	Method
Progression free survival (PFS)	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

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

Trial Locations

Locations (1)

Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital; 🇨🇳 Zhengzhou, Henan, China