Back to resultsNeoadjuvant Nab-Paclitaxel and S-1 in Resectable Pancreatic Cancer
Primary Purpose
Pancreatic Neoplasms
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Nab paclitaxel and S-1
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Neoplasms
Eligibility Criteria
Inclusion Criteria:
- Signed informed-consent form;
- Treatment-naive PDAC with histological or cytological diagnosis;
- Resectable pancreatic cancer stage II and partial stage III defined according to the National Comprehensive Cancer Network definitions;
- Age≥18 years old and ≤70 years old;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- BMI≥18.5 and NRS2002score<3;
- Expected survival over 3 months;
- Spared organ function satisfying the following laboratory data:leucocyte≥3.0x109/L,neutrophils≥1.5x109/L, hemoglobin≥ 9g/dL, platelets ≥100x109/L, total bilirubin ≤ 1.5 ULN; AST and ALT≤ 2.5 ULN; serum creatinine≤1.5ULN; PT and INR≤ 2.5 ULN;
Exclusion Criteria:
- Severe Impaired organ functions;
- Patients who had surgeries, chemotherapy or other treatments before inclusion;
- Pregnant women or lactating women;
- Ineligible by the discretion of the investigator.
Sites / Locations
- Tianjin Medical University Cancer Institute and 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 2-4 cycles
Outcomes
Primary Outcome Measures
Objective response rate
Percentage of patients who achieve partial response (PR) or complete response(CR) based on Response Evaluation Criteria In Solid Tumors (RECIST1.1)
Secondary Outcome Measures
R0/R1 resection rate
proportion of patients who achieved R0/R1 resection
Disease free survival
The time between operation and the relapse or metastasis of tumors or death
Overall survival
The time between randomization and death from any cause or lost to follow-up
Full Information
NCT ID
NCT04808687
First Posted
March 17, 2021
Last Updated
March 18, 2021
Sponsor
Tianjin Medical University Cancer Institute and Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04808687
Brief Title
Neoadjuvant Nab-Paclitaxel and S-1 in Resectable Pancreatic Cancer
Official Title
Phase II Single-arm Trial of Nab-Paclitaxel and S-1 as Neoadjuvant Treatment of Patients With Resectable Pancreatic Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Recruiting
Study Start Date
March 2021 (Anticipated)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Medical University Cancer Institute and Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
There were limited data for nab-paclitaxel and S-1 in pancreatic cancer. To explore the efficacy and safety of neoadjuvant nab-paclitaxel combined with S-1 in patients with resectable pancreatic cancer (stage II and partial stage III defined according to the National Comprehensive Cancer Network definitions ), we designed this study. This study was a single-arm single center prospective phase II clinical study. A total of 72 subjects who meet the criteria will receive neoadjuvant chemotherapy of nab-paclitaxel and S-1 prior to pancreatectomy. Response was reported according to the Response Evaluation Criteria in Solid Tumors guidelines (RECIST, version 1.1) .The primary endpoint is objective response rate. The secondary endpoints include R0/R1 resection rate, disease free survival, overall survival and safety.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
72 (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 2-4 cycles
Intervention Type
Drug
Intervention Name(s)
Nab paclitaxel and S-1
Intervention Description
Nab-Paclitaxel: 125 mg/m2 d1, 8, during each 3-week cycle. S-1: Body surface area < 1.25 m2, 40 mg bid; Body surface area ≥ 1.25 m2 < 1.50 m2, 50 mg bid; Body surface area ≥1.5 m2, 60 mg bid, d1-14;during each 3-week cycle.
Primary Outcome Measure Information:
Title
Objective response rate
Description
Percentage of patients who achieve partial response (PR) or complete response(CR) based on Response Evaluation Criteria In Solid Tumors (RECIST1.1)
Time Frame
From date of first dose until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 24 months
Secondary Outcome Measure Information:
Title
R0/R1 resection rate
Description
proportion of patients who achieved R0/R1 resection
Time Frame
2 years
Title
Disease free survival
Description
The time between operation and the relapse or metastasis of tumors or death
Time Frame
From date of randomization until the date of first documented progression or metastasis, assessed up to 12 months
Title
Overall survival
Description
The time between randomization and death from any cause or lost to follow-up
Time Frame
From date of randomization until the date of death from any cause or censored at the last day that the patient is documented to be alive, whichever came first, assessed up to 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed informed-consent form;
Treatment-naive PDAC with histological or cytological diagnosis;
Resectable pancreatic cancer stage II and partial stage III defined according to the National Comprehensive Cancer Network definitions;
Age≥18 years old and ≤70 years old;
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
BMI≥18.5 and NRS2002score<3;
Expected survival over 3 months;
Spared organ function satisfying the following laboratory data:leucocyte≥3.0x109/L,neutrophils≥1.5x109/L, hemoglobin≥ 9g/dL, platelets ≥100x109/L, total bilirubin ≤ 1.5 ULN; AST and ALT≤ 2.5 ULN; serum creatinine≤1.5ULN; PT and INR≤ 2.5 ULN;
Exclusion Criteria:
Severe Impaired organ functions;
Patients who had surgeries, chemotherapy or other treatments before inclusion;
Pregnant women or lactating women;
Ineligible by the discretion of the investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jihui Hao
Phone
022-23340123-3077
Email
tjzlyypc@126.com
Facility Information:
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
30000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jihui Hao
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Neoadjuvant Nab-Paclitaxel and S-1 in Resectable Pancreatic Cancer
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