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

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03850769
Collaborator
(none)
60
Enrollment
1
Location
1
Arm
35
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: nab-paclitaxel and S-1
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
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
Actual Study Start Date :
May 1, 2019
Anticipated Primary Completion Date :
Mar 1, 2022
Anticipated Study Completion Date :
Apr 1, 2022

Arms and Interventions

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;

Outcome Measures

Primary Outcome Measures

  1. R0 resection rate [3 years]

    proportion of patients who achieved R0 resection

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

  1. Not able to take medicine orally.

  2. Pregnancy or lactation, and women of childbearing age who refused to take appropriate contraceptive measures during the course of this study;

  3. Participation in other clinical trial within 30 days before the first dose of the drug;

Contacts and Locations

Locations

Site City State Country Postal Code
1 Peking Union Medical College Hospital Beijing Beijing China

Sponsors and Collaborators

  • Peking Union Medical College Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT03850769
Other Study ID Numbers:
  • HS-1752
First Posted:
Feb 22, 2019
Last Update Posted:
Mar 10, 2020
Last Verified:
Feb 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Pancreatic Neoplasms
Paclitaxel

Study Results

No Results Posted as of Mar 10, 2020