Study of Gemcitabine Plus Nab-paclitaxel Versus S1 Plus Nab-paclitaxel in Metastatic Adenocarcinoma of the Pancreas

Last updated: July 4, 2019
Sponsor: Wuhan Union Hospital, China
Overall Status: Active - Recruiting

Phase

2

Condition

Pancreatic Cancer

Digestive System Neoplasms

Cancer

Treatment

N/A

Clinical Study ID

NCT03779464
XHZL-001
  • Ages 18-70
  • All Genders

Study Summary

A randomized multi-center phase II trial of nab-paclitaxel in combination with gemcitabine verus S1 with gemcitabine as first-Line treatment for locally advanced or metastatic pancreatic cancer

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histological or cytological confirmation of pancreatic adenocarcinoma

  • Distant metastatic or unresctable locally advanced diseases

  • CTScan (or MRI if scanner contraindicated) completed within 3 weeks of the start oftreatment

  • At least one lesion measurable by RECIST v1.1 criteria

  • Life expectancy> 3 months

  • No previous chemotherapy (adjuvant chemotherapy with gemcitabine authorised ifadministered more than 6 months prior to inclusion)

  • No previous radiotherapy (unless at least one measurable target lesion outside theirradiation zone)

  • Pain must be monitored before inclusion

  • 18 years < age < 70

  • Performance status: 0-1

  • ANC ≥ 1500/mm3, platelets ≥ 100 000/mm3, haemoglobin ≥ 9 g/dL

  • ASAT (SGOT), ALAT (SGPT) ≤ 2.5 x ULN or ≤ 5 x ULN if liver metastases found

  • Bilirubin ≤ 1.5 x ULN (patients drained by retrograde technique are includable),

  • creatinine < 120 μmol/L, or MDRD creatinine clearance > 60 mL/min

  • Patient information and signature of informed consent

Exclusion

Exclusion Criteria:

  • Concurrent other effective treatment (including radiotherapy)

  • Resectable patients

  • Allergy history to other drugs in the same class patients with pregnancy or lactation

  • Known severe internal medical diseases

  • Abnormal heart function or relevant history of myocardial infarction and severearrhythmia

  • Immunocompromised patients, such as HIV positive

  • Uncontrollable mental illness

  • Other conditions the researchers considered ineligible for the study

Study Design

Total Participants: 132
Study Start date:
August 01, 2019
Estimated Completion Date:
September 30, 2021

Study Description

A Phase II, open-label randomized, multicenter trial to compare nab-paclitaxel in combination with gemcitabine verus S1 with gemcitabine with respect to overall survival, objective tumor response rate and Progression Free Survival (PFS) in patients diagnosed with locally advanced or metastatic adenocarcinoma of the pancreas.

Connect with a study center

  • Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei 430022
    China

    Active - Recruiting

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