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UNKNOWNPHASE2

Nab-paclitaxel and Gemcitabine in Metastatic Pancreatic Cancer

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

NCT03929094•Fudan University

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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 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.
•3. Age and reproductive status
•* Age ≥ 18 years and ≤ 75 years
+2 more criteria

Exclusion Criteria

•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 taxa regimen.
•* Patients who had Grade 2 or above Peripheral neuropathy.
•3. Abnormal results of physical examination and laboratory examination
+9 more criteria

Locations (1)

FUDAN University

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

March 1, 2019

Primary Completion Date

December 31, 2021

Completion Date

December 31, 2021

Last Updated

April 26, 2019

Enrollment

120

ESTIMATED participants

Conditions

Metastatic Pancreatic Cancer

Interventions

Paclitaxel for Injection（Albumin Bound）

DRUG

Gemcitabine

DRUG

Contacts

Xian-Jun Yu, M.D., Ph.D.

CONTACT

+86 21 64175590 yuxianjun@fudanpci.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 26, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Nab-paclitaxel and Gemcitabine in Metastatic Pancreatic Cancer

Inclusion Criteria

Exclusion Criteria

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