Advanced Gastrointestinal Tumors
Conditions
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.
Interventions
DRUGAlbumin 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.
Sponsors
Henan Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactXifang Hou
Outcome results
None listed