Treatment of Advanced Gastrointestinal Tumors With Albumin Taxol

NCT03977077 | Unknown

• 1 other identifier: AYGAS-0531
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Objective remission rate (ORR)

  up to 2 year

• Overall survival

  up to 2 year

Study Arms (1)

Albumin binding taxol

EXPERIMENTAL

Drug: Albumin binding taxol

Interventions

Albumin binding taxol 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.

Albumin binding taxol

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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；

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

Location

Central Study Contacts

Xifang Hou

CONTACT

15136130286; houxinfang2013@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2019
• First Posted: June 6, 2019
• Study Start: June 1, 2019
• Primary Completion: October 31, 2019
• Study Completion: October 31, 2020
• Last Updated: June 6, 2019

Record last verified: 2019-05

Locations

CN (1)