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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Neoplasms
• Intervention / Treatment: Drug: Nab paclitaxel and S-1

• Study Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jihui Hao; Phone Number: 022-23340123-3077; Email: tjzlyypc@126.com

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 30000
      • Recruiting
      • Tianjin Medical University Cancer Institute and Hospital
      • Contact: Jihui Hao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: nab-paclitaxel and S-1; neoadjuvant chemotherapy with Nab-paclitaxel and S-1, repeat every 21 days for 2-4 cycles	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
R0/R1 resection rate	proportion of patients who achieved R0/R1 resection	2 years
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
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

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2021
• Primary Completion (Anticipated): February 1, 2023
• Study Completion (Anticipated): February 1, 2024

Study Registration Dates

• First Submitted: March 17, 2021
• First Submitted That Met QC Criteria: March 18, 2021
• First Posted (Actual): March 22, 2021

Study Record Updates

• Last Update Posted (Actual): March 22, 2021
• Last Update Submitted That Met QC Criteria: March 18, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel
• Other Study ID Numbers: TZ-PC02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No