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

Phase 2

• Conditions: Pancreatic Neoplasms
• Interventions: Drug: Nab paclitaxel and S-1

• Registration Number: NCT04808687
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-03
• Study Start: 2021-03
• Study First Submitted: 2021-03-17
• Study First Submitted QC: 2021-03-18
• Last Update Submitted: 2021-03-18
• Study First Posted: 2021-03-22
• Last Update Posted: 2021-03-22
• Primary Completion: 2023-02
• Study Completion: 2024-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 72

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Objective response rate	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	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

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

Trial Locations

Locations (1)

Tianjin Medical University Cancer Institute and Hospital; 🇨🇳 Tianjin, Tianjin, China