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

NCT03850769 | Unknown Phase 2

• 1 other identifier: HS-1752
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Borderline Resectable Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• R0 resection rate

  proportion of patients who achieved R0 resection

  3 years

Study Arms (1)

nab-paclitaxel and S-1

EXPERIMENTAL

neoadjuvant chemotherapy with Nab-paclitaxel and S-1, repeat every 21 days for 4 cycles.

Drug: nab-paclitaxel and S-1

Interventions

nab-paclitaxel and S-1 DRUG

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;

nab-paclitaxel and S-1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• ≥ Grade 2 existing peripheral neuropathy;
• 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.
• Active, uncontrolled infection(s) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate treatment.
• 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.
• Not able to take medicine orally.
• Pregnancy or lactation, and women of childbearing age who refused to take appropriate contraceptive measures during the course of this study;
• Participation in other clinical trial within 30 days before the first dose of the drug;

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Interventions

130-nm albumin-bound paclitaxel; S 1 (combination)

Central Study Contacts

TaiPing Zhang, MD

CONTACT

13520132976; Tpingzhang@yahoo.com

YueJuan Cheng, MD

CONTACT

861069158315; cnchengyuejuan@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2019
• First Posted: February 22, 2019
• Study Start: May 1, 2019
• Primary Completion: March 1, 2022
• Study Completion: April 1, 2022
• Last Updated: March 10, 2020

Record last verified: 2020-02

Locations

CN (1)