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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03929094
Recruitment Status Recruiting
First Posted April 26, 2019
Last update posted April 26, 2019
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.
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.
|Experimental: nab-paclitaxel + gemcitabine
nab-paclitaxel at 100 mg/m^2 on days 1, 8, and 15; gemcitabine at 1000 mg/m^2 on days 1, 8, and 15
Drug: Paclitaxel for Injection（Albumin Bound）
Patients firstly receive nab-paclitaxel 100 mg/m^2 (iv, 30 minutes) on days 1, 8, and 15 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.
Patients secondly receive gemcitabine 1000 mg/m^2 (iv, 30 minutes) on days 1, 8, and 15 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
1. 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.
2. target population
- the patients were confirmed as metastatic pancreatic cancer by histopathology or
- 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.
3. 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.
1. The target disease has cerebral metastasis;
2. 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
- Patients who had Grade 2 or above Peripheral neuropathy.
3. 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
4. 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. 5. Human immunodeficiency virus (HIV)- or hepatitis C virus (HCV) positive patients; 6. Patients combined with other anti-tumor drugs. 7. Participation in any trial drug treatment or another interventional clinical trial 30 days before screening period. 8. The researchers considered that there were other conditions that were not suitable for enrollment.
Contact: Xian-Jun Yu, M.D., Ph.D. +86 21 64175590 email@example.com
CSPC Ouyi Pharmaceutical Co., Ltd.
Study Director: Xian-Jun Yu Fudan University