Treatment of Advanced Gastrointestinal Tumors With Albumin Taxol

NCT ID: NCT03977077

Last Updated: 2019-06-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2020-10-31

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.

Conditions

Advanced Gastrointestinal Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Albumin binding taxol

Group Type: EXPERIMENTAL

Albumin binding taxol

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henan Cancer Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital

Zhengzhou, Henan, China

Countries

China

Central Contacts

Xifang Hou

Role: CONTACT

houxinfang2013@163.com

15136130286

Other Identifiers

AYGAS-0531

Identifier Type: -

Identifier Source: org_study_id