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Trial record 13 of 266 for:    Pancreatic Cancer AND Resectable

Neoadjuvant Nab-Paclitaxel and S-1 in Borderline Resectable Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT03850769
Recruitment Status : Recruiting
First Posted : February 22, 2019
Last Update Posted : February 22, 2019
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital

Brief Summary:
This study was a single-arm multicenter prospective phase II clinical study, designed to evaluate the efficacy and safety of neoadjuvant nab-paclitaxel combined with S-1 in patients with borderline resectable pancreatic cancer. A total of 60 subjects who meet the criteria will receive neoadjuvant chemotherapy of nab-paclitaxel and S-1, for a maximum of 4 cycles prior to pancreatectomy. The primary endpoint is R0 resection rate, the secondary endpoints include overall survival and response rate.

Condition or disease Intervention/treatment Phase
Borderline Resectable Pancreatic Cancer Drug: nab-paclitaxel and S-1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Phase II Single-arm Study of Neoadjuvant Nab-Paclitaxel and S-1 in Patients With Borderline Resectable Pancreatic Cancer
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

Arm Intervention/treatment
Experimental: nab-paclitaxel and S-1
neoadjuvant chemotherapy with Nab-paclitaxel and S-1, repeat every 21 days for 4 cycles.
Drug: nab-paclitaxel and S-1
Nab-Paclitaxel: 120 mg/m2 d1, 8, S-1: Body surface area < 1.25 m2, 80 mg/d; Body surface area ≥ 1.25 m2 < 1.50 m2, 100 mg/d; Body surface area ≥1.5 m2, 120 mg/d; Bid, d1-14;




Primary Outcome Measures :
  1. R0 resection rate [ Time Frame: 3 years ]
    proportion of patients who achieved R0 resection



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients have good compliance, can understand the research process of this study, and sign a written informed consent
  2. Patients with pathologically confirmed pancreatic adenocarcinoma.
  3. Patients who have not received prior chemotherapy, radiotherapy or other systematic treatment for pancreatic cancer;
  4. Patients with borderline resectable pancreatic cancer ( NCCN Version 1,2019 criteria).
  5. ECOG PS 0-1;
  6. Tumor size is measurable according to RECIST1.1 criteria
  7. Expected survival over 3 months;
  8. Bone marrow function: neutrophils≥1.5x109/L, platelets ≥100x109/L, hemoglobin≥ 90g/L;
  9. Liver and kidney function: serum creatinine≤1.5ULT; AST and ALT≤ 2.5 ULT; total bilirubin ≤ 1.5 ULT;
  10. No contraindications to the use of S-1 and nab-paclitaxel.

Exclusion Criteria:

  1. ≥ Grade 2 existing peripheral neuropathy;
  2. Any other malignancy within 5 years prior to enrollment, with the exception of adequately treated in-situ carcinoma of the cervix, uteri, bladder, or nonmelanomatous skin cancer.
  3. Active, uncontrolled infection(s) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate treatment.
  4. Severe, active co-morbidity, defined as follows:

    Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months Transmural myocardial infarction within the 6 months of study registration Uncontrolled hypertension, diabetes or arrhythmia. Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization.

  5. Not able to take medicine orally.
  6. Pregnancy or lactation, and women of childbearing age who refused to take appropriate contraceptive measures during the course of this study;
  7. Participation in other clinical trial within 30 days before the first dose of the drug;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03850769


Contacts
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Contact: TaiPing Zhang, MD 13520132976 Tpingzhang@yahoo.com
Contact: YueJuan Cheng, MD 861069158315 cnchengyuejuan@yahoo.com

Locations
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China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China
Contact: YueJuan Cheng    861069158315    cnchengyuejuan@yahoo.com   
Sponsors and Collaborators
Peking Union Medical College Hospital

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Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03850769     History of Changes
Other Study ID Numbers: HS-1752
First Posted: February 22, 2019    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Digestive System Diseases
Endocrine System Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action