A Phase II, Single-arm Study to Evaluate the Efficacy and Safety of the Combination of Nab-paclitaxel and Gemcitabine in Treating Patients With Metastatic Pancreatic Cancer
Overview
- Phase
- Phase 2
- Intervention
- Paclitaxel for Injection（Albumin Bound）
- Conditions
- Metastatic Pancreatic Cancer
- Sponsor
- Fudan University
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Overall Response Rate
- Last Updated
- 7 years ago
Overview
Brief 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.
Detailed 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.
Investigators
Xian-Jun Yu
Principal Investigator
Fudan University
Eligibility Criteria
Inclusion Criteria
- •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
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
Arms & Interventions
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
Intervention: Paclitaxel for Injection（Albumin Bound）
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
Intervention: Gemcitabine
Outcomes
Primary Outcomes
Overall Response Rate
Time Frame: through study completion, an average of 1 year
To evaluate the Overall Response Rate of patients with metastatic pancreatic cancer after treated with nab-paclitaxel plus gemcitabine.
Progression Free Survival
Time Frame: through study completion, an average of 1 year
To evaluate the Progression Free Survival of patients with metastatic pancreatic cancer after treated with nab-paclitaxel plus gemcitabine.
Secondary Outcomes
- adverse events(through study completion, an average of 1 year)
- overall survival(through study completion, an average of 1 year)