Nab-paclitaxel and Gemcitabine in Metastatic Pancreatic Cancer

  • STATUS
    Recruiting
  • End date
    Dec 31, 2021
  • participants needed
    120
  • sponsor
    Fudan University
Updated on 22 January 2021

Summary

This is a single arm, open-label Phase II clinical trial to Evaluate the Efficacy and Safety of the Combination of Nab-paclitaxel and Gemcitabine in Treating Patients with metastatic pancreatic cancer.

Description

While GT (Gemcitabine + Nab-paclitaxel) is one of the preferred regimens for metastatic pancreatic cancer, we have yet to determine the optimum number of cycles for GT treatment regimen. In this single arm, open-label clinical trial, metastatic pancreatic cancer patients will be received nab-paclitaxel 100 mg/m^2 (iv, 30 minutes) and gemcitabine 1000 mg/m^2 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks until the disease recurrence or unacceptable toxicity, death or begin a novel therapeutic.

The safety and efficacy of each group will be assessed through ORR, PFS, OS and adverse effects as graded by CTC-AE 5.0.

Details
Condition Metastatic Pancreatic Cancer
Treatment Gemcitabine, Paclitaxel for Injection(Albumin Bound)
Clinical Study IdentifierNCT03929094
SponsorFudan University
Last Modified on22 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 75 yrs?
Gender: Male or Female
Do you have any of these conditions: Do you have Metastatic Pancreatic Cancer??
Signed informed content obtained prior to treatment. The patients were fully explained and understood the purpose, contents, predicted efficacy, pharmacological effects, and risks of this study
target population
the patients were confirmed as metastatic pancreatic cancer by histopathology or cytopathology
At least one measurable objective lesion (both primary and metastatic) was identified based on the RECIST1.1 criteria
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
The expected survival after surgery 3 months
The subjects have good compliance, can be treated and followed up, and voluntarily comply with the relevant provisions of this study
No contraindications for gemcitabine and nab-paclitaxel
Age and reproductive status
Age 18 years and 75 years
Subjects of child-bearing age must agree to take effective contraceptive measures during the study period; Serum or urine pregnancy tests must be negative for women of childbearing age 24 hours before the start of chemotherapy
Women must not lactate

Exclusion Criteria

The target disease has cerebral metastasis
medical history and complications
patients had uncontrolled serious medical condition that the investigator considered may affect the subject's to receive treatment under the study program, For example, patients with severe medical diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc
Dementia, changing of mental state or any mental illness which could hinder understanding or informed consent or fill out questionnaires
History of allergy or hypersensitivity to any therapeutic ingredient
Combined with other malignant tumors excepted pancreatic cancer within the first 5 years of randomization, excepted well-treated basal cell or squamous cell carcinoma of the skin, localized prostate cancer after radical resection, and ductal carcinoma in situ of the breast after radical resection
Previously received systemic therapy for advanced/metastatic pancreatic cancer
Subjects who had previously been pathologically diagnosed with squamous cell carcinoma (no organ limitation) and received neoadjuvant/adjuvant therapy with taxa regimen
Patients who had Grade 2 or above Peripheral neuropathy
Abnormal results of physical examination and laboratory examination
Absolute neutrophil count (ANC) 90g/L 1.5 109/L; Platelets (PLT) 90g/L 100 109/L; Hemoglobin (Hgb) < 90g/L
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]/ alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) >2.5 institutional upper limit of normal (ULN), >5 institutional upper limit of normal (ULN) (hepatic metastases); Total bilirubin (TBIL)>1.5 ULN
Creatinine (CRE)> 1.5 ULN
Prothrombin time (PT) and international normalized ratio (INR) > 1.5 ULN. Unless the subject had received anticoagulant treatment
Subjects had hepatitis b surface antigen (HBsAg)-positive and hbv-dna titer in peripheral blood greater than or equal to 1000 copy number /L;If HBsAg is positive and the peripheral blood hbv-dna <1000 copy number /L, the subjects will be eligible for inclusion if the investigator considers that chronic hepatitis b is stable and does not increase the risk of subjects
Human immunodeficiency virus (HIV)- or hepatitis C virus (HCV) positive patients
Patients combined with other anti-tumor drugs
Participation in any trial drug treatment or another interventional clinical trial 30 days before screening period
The researchers considered that there were other conditions that were not suitable for enrollment
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