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

Primary Purpose

Borderline Resectable Pancreatic Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

nab-paclitaxel and S-1

About this trial

This is an interventional treatment trial for Borderline Resectable Pancreatic Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

≥ 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;

Sites / Locations

Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

nab-paclitaxel and S-1

Arm Description

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

Outcomes

Primary Outcome Measures

R0 resection rate

proportion of patients who achieved R0 resection

Secondary Outcome Measures

Full Information

NCT ID

NCT03850769

First Posted

February 20, 2019

Last Updated

March 8, 2020

Sponsor

Peking Union Medical College Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03850769

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Unknown status

Study Start Date

May 1, 2019 (Actual)

Primary Completion Date

March 2022 (Anticipated)

Study Completion Date

April 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Peking Union Medical College Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Borderline Resectable Pancreatic Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

nab-paclitaxel and S-1

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

nab-paclitaxel and S-1

Intervention Description

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;

Primary Outcome Measure Information:

Title

R0 resection rate

Description

proportion of patients who achieved R0 resection

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: ≥ 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;

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

TaiPing Zhang, MD

Phone

13520132976

Tpingzhang@yahoo.com

First Name & Middle Initial & Last Name or Official Title & Degree

YueJuan Cheng, MD

Phone

861069158315

cnchengyuejuan@yahoo.com

Facility Information:

Facility Name

Peking Union Medical College Hospital

City

Beijing

State/Province

Beijing

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

YueJuan Cheng

Phone

861069158315

cnchengyuejuan@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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