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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 10, 2020
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital

Tracking Information
First Submitted Date  ICMJE February 20, 2019
First Posted Date  ICMJE March 21, 2019
Last Update Posted Date March 10, 2020
Actual Study Start Date  ICMJE May 1, 2019
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 19, 2019)		 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2019)		 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nab-paclitaxel and S-1 in Patients With Locally Advanced Pancreatic Cancer
Official Title  ICMJE Prospective Phase II Single-arm Study of Nab-paclitaxel and S-1 in Patients With Locally Advanced Pancreatic Cancer.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Locally Advanced Pancreatic Cancer
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Drug: Nab-paclitaxel and S-1
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 19, 2019)		 60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2022
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: TaiPing Zhang 13520132976 Tpingzhang@yahoo.com
Contact: YueJuan Cheng 861069158315 cnchengyuejuan@yahoo.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03885219
Other Study ID Numbers  ICMJE HS-1751
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Peking Union Medical College Hospital
Study Sponsor  ICMJE Peking Union Medical College Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Peking Union Medical College Hospital
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP