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Nab-paclitaxel Plus S-1(AS) Versus Nab-paclitaxel Plus Gemcitabine(AG) in Patients With Advanced Pancreatic Cancer

NCT03636308 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-08-17

No results posted yet for this study

Summary

This is a randomized phase II trial comparing the first-line treatment with nab-paclitaxel plus S-1(AS) and nab-paclitaxel plus gemcitabine(AG) in advanced pancreatic ductal adenocarcinoma (PDA) with primary tumor nonexcision in Chinese patients.

Conditions

Interventions

DRUG

nanoparticle albumin-bound paclitaxel

Nanoparticle albumin-bound paclitaxel is given at 125 mg/m2 intravenously on day 1 of each 14 day cycle or day 1 and 8 of 21 day cycle.

DRUG

S1

S-1 is orally administered (BSA\<1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2, 50mg bid, BSA\>1.5m2, 60mg bid) on day 1-7 of each 14 day cycle.

DRUG

Gemcitabine

Gemcitabine is given at 1000mg/m2 intravenously on d1 and 8 of each 21 day cycle.

Sponsors & Collaborators

  • Peking University

    lead OTHER

Principal Investigators

  • Lin Shen, Professor · Peking University Cancer Hospital & Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-17
Primary Completion
2020-08-01
Completion
2021-08-01

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

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 NCT03636308 on ClinicalTrials.gov