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Nab-P and Gem Compared With Gem and Tegafur in Adjuvant Chemotherapy After Radical Resection of Pancreatic Cancer

NCT04216758 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2020-06-30

No results posted yet for this study

Summary

Treatment, Prospective, Assignment, Open Label, Single-center, Non-randomized Study An exploratory clinical trial of comparison of Nab-Paclitaxel combined with Gemcitabine and Gemcitabine combined with Tegafur for adjuvant chemotherapy after radical resection of pancreatic cancer

Conditions

  • Stage IA Pancreatic Adenocarcinoma
  • Stage IB Pancreatic Adenocarcinoma
  • Stage IIA Pancreatic Adenocarcinoma
  • Stage IIB Pancreatic Adenocarcinoma

Interventions

DRUG

nab-paclitaxel

Patients firstly receive nab-paclitaxel 100 mg/m\^2 (iv, 30 minutes) on days 1, 8, and 15 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks for up to 6 circles in the absence of disease recurrence or unacceptable toxicity.

DRUG

Gemcitabine

Patients receive gemcitabine 1000 mg/m\^2 (iv, 30 minutes) on days 1, 8, and 15 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks for up to 6 circles in the absence of disease recurrence or unacceptable toxicity.

DRUG

tegafur

Patients secondly receive tegafur Body surface area \< 1.25 m\^2, 60 mg/d;Body surface area ≥ 1.25 m\^2 to \< 1.5 m\^2, 80 mg/d;Body surface area ≥ 1.5 m\^2, 100 mg/d (po) on days 1-21 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks for up to 6 circles in the absence of disease recurrence or unacceptable toxicity.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Xian-Jun Yu, M.D Ph.D · Fudan University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2020-07-31
Completion
2020-12-31

Countries

  • China

Study Locations

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Entities

Drugs

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 NCT04216758 on ClinicalTrials.gov