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

Borderline Resectable Pancreatic Cancer Clinical Trial

Official title:

Prospective Phase II Single-arm Study of Neoadjuvant Nab-Paclitaxel and S-1 in Patients With Borderline Resectable Pancreatic Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03850769
• Other study ID #: HS-1752
• Status: Recruiting
• Phase: Phase 2
• Start date: May 1, 2019
• Est. completion date: April 2022

Study information

• Verified date: February 2020
• Source: Peking Union Medical College Hospital
• Contact: TaiPing Zhang, MD
• Phone: 13520132976
• Email: Tpingzhang[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

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;

Related Conditions & MeSH terms

• Borderline Resectable Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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;

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	R0 resection rate	proportion of patients who achieved R0 resection	3 years