Treatment of Advanced Gastrointestinal Tumors With Albumin Taxol

Henan Cancer Hospital

Status: Unknown

Conditions: Advanced Gastrointestinal Tumors

Treatments: Drug: Albumin binding taxol

Study type: Interventional

Funder types: Other

Identifiers

NCT03977077

AYGAS-0531

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Albumin binding taxol

Experimental group

Treatment:

Drug: Albumin binding taxol