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

Last updated: March 8, 2020
Sponsor: Peking Union Medical College Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Digestive System Neoplasms

Treatment

N/A

Clinical Study ID

NCT03885219
HS-1751
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients have good compliance, can understand the research process of this study, andsign a written informed consent

  2. Patients with pathologically confirmed pancreatic adenocarcinoma.

  3. Patients who have not received prior chemotherapy, radiotherapy or other systematictreatment 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; totalbilirubin ≤ 1.5 ULT;

  10. No contraindications to the use of S-1 and nab-paclitaxel.

Exclusion

Exclusion Criteria:

  1. ≥ Grade 2 existing peripheral neuropathy;

  2. Any other malignancy within 5 years prior to enrollment, with the exception ofadequately treated in-situ carcinoma of the cervix, uteri, bladder, or nonmelanomatousskin cancer.

  3. Active, uncontrolled infection(s) requiring systemic therapy, defined as ongoingsigns/symptoms related to the infection without improvement despite appropriatetreatment.

  4. Severe, active co-morbidity, defined as follows: Unstable angina and/or congestive heart failure requiring hospitalization within thelast 6 months Transmural myocardial infarction within the 6 months of studyregistration Uncontrolled hypertension, diabetes or arrhythmia. Chronic obstructivepulmonary 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 appropriatecontraceptive measures during the course of this study;

  7. Participation in other clinical trial within 30 days before the first dose of thedrug;

Study Design

Total Participants: 60
Study Start date:
May 01, 2019
Estimated Completion Date:
April 30, 2022

Connect with a study center

  • Peking Union Medical College Hospital

    Beijing, Beijing
    China

    Active - Recruiting

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