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

Pancreatic Neoplasms Clinical Trial

Official title:

Phase II Single-arm Trial of Nab-Paclitaxel and S-1 as Neoadjuvant Treatment of Patients With Resectable Pancreatic Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04808687
• Other study ID #: TZ-PC02
• Status: Recruiting
• Phase: Phase 2
• Start date: March 2021
• Est. completion date: February 2024

Study information

• Verified date: March 2021
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: Jihui Hao
• Phone: 022-23340123-3077
• Email: tjzlyypc[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: February 2024
• Est. primary completion date: February 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Signed informed-consent form;

2. Treatment-naive PDAC with histological or cytological diagnosis;

3. Resectable pancreatic cancer stage II and partial stage III defined according to the National Comprehensive Cancer Network definitions;

4. Age=18 years old and =70 years old;

5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;

6. BMI=18.5 and NRS2002score<3;

7. Expected survival over 3 months;

8. 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:

1. Severe Impaired organ functions;

2. Patients who had surgeries, chemotherapy or other treatments before inclusion;

3. Pregnant women or lactating women;

4. Ineligible by the discretion of the investigator.

Related Conditions & MeSH terms

• Pancreatic Neoplasms

Intervention

Drug:
• Nab paclitaxel and S-1
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.

Locations

Country	Name	City	State
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	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	R0/R1 resection rate	proportion of patients who achieved R0/R1 resection	2 years
Secondary	Disease free survival	The time between operation and the relapse or metastasis of tumors or death	From date of randomization until the date of first documented progression or metastasis, assessed up to 12 months
Secondary	Overall survival	The time between randomization and death from any cause or lost to follow-up	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