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Nab-paclitaxel and S-1 in Patients With Locally Advanced Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT03885219
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital

Brief Summary:
This study is a single-arm, multi-center, open-label prospective phase II clinical study designed to evaluate the efficacy and safety of nab-paclitaxel and S-1 in patients with locally advanced pancreatic cancer. A total of 60 subjects who meet the criteria will be treated with nab-paclitaxel and S-1. The primary endpoint is 6 months progression free survival rate, and secondary endpoints include objective response rate, overall survival, progression free survival and toxicities.

Condition or disease Intervention/treatment Phase
Locally Advanced 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 Nab-paclitaxel and S-1 in Patients With Locally Advanced Pancreatic Cancer.
Estimated Study Start Date : May 1, 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
chemotherapy of Nab-Paclitaxel and S-1, repeat 21 days for up to 8 cycles. The following treatment including pancreatectomy, continuing same chemotherapy, S-1 maintenance therapy, or radiotherapy will be decided after discussion between physicians and patients.
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 , < 1.5 m2, 100 mg/d; Body surface area ≥1.5 m2, 120 mg/d; Bid, d1-14; repeat every 21 days.




Primary Outcome Measures :
  1. 6-month progression-free survival (PFS) [ Time Frame: 6 months ]
    The proportion of patients who did not experience disease progression or die from disease progression within 6 months from the registration.


Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: From date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months. ]
    Refers to the proportion of patients with partial tumor remission (PR) and complete remission (CR).



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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 locally advanced 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): NCT03885219


Contacts
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Contact: TaiPing Zhang 13520132976 Tpingzhang@yahoo.com
Contact: YueJuan Cheng 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: NCT03885219     History of Changes
Other Study ID Numbers: HS-1751
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: March 21, 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