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

NCT ID: NCT04808687

Last Updated: 2021-03-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-31
• Study Completion Date: 2024-02-29

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.

Conditions

Pancreatic Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

nab-paclitaxel and S-1

neoadjuvant chemotherapy with Nab-paclitaxel and S-1, repeat every 21 days for 2-4 cycles

Group Type: EXPERIMENTAL

Nab paclitaxel and S-1

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jihui Hao

Role: CONTACT

tjzlyypc@126.com

022-23340123-3077

Facility Contacts

Jihui Hao

Role: primary

Other Identifiers

TZ-PC02

Identifier Type: -

Identifier Source: org_study_id