MedTrace Logo

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

NCT04808687 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2021-03-22

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Tianjin Medical University Cancer Institute and Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-31
Primary Completion
2023-02-28
Completion
2024-02-29

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04808687 on ClinicalTrials.gov