A Phase II Randomized Study of Gemcitabine and Nab-paclitaxel in Combination With S- 1/LV (GASL) or Oxaliplatin (GAP) as First-line Treatment for Metastatic Pancreatic Cancer

  • STATUS
    Recruiting
  • End date
    Dec 31, 2027
  • participants needed
    86
  • sponsor
    National Health Research Institutes, Taiwan
Updated on 30 June 2022

Summary

Gemcitabine and nab-paclitaxel are one standard of care for metastatic pancreatic adenocarcinoma (mPDAC) but the progression free survival (PFS) of the regimen is only 5.5 months. Previous phase II study showed gemcitabine and nab-paclitaxel plus cisplatin had a PFS of 10.1 months in mPDAC. However, the nephrotoxicity of cisplatin is always a concern therefore cisplatin was substituted with oxaliplatin in current study. S-1 monotherapy has shown promising anti-tumor activity against PDAC with a manageable safety profile which provided the opportunity of combination with other agents. In this study, we will evaluate the efficacy and safety of gemcitabine, nab-paclitaxel plus S-1/LV (GASL) against gemcitabine, nab-paclitaxel plus oxaliplatin (GAP) in patients with mPDAC.

Details
Condition Phase II, Open-label, Parallel 2-arm, Multi-center
Treatment Oxaliplatin, Leucovorin, S1, Gemcitabine 1000 mg, nab paclitaxel
Clinical Study IdentifierNCT05026905
SponsorNational Health Research Institutes, Taiwan
Last Modified on30 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

A.Cytology or histology confirmed pancreatic adenocarcinoma with evidence of distant metastasis
B.No history of prior chemotherapy for pancreatic cancer, except adjuvant chemotherapy that completed at least 6 months before documentation of recurrence by imaging study
C.Patients with prior radiotherapy are eligible if there are other measurable target lesions that is not irradiated
D.At least one measurable lesion according to RECIST version 1.1
E.Ability to understand and willingness to sign a written informed consent document
F.ECOG performance status 0-1
G.Age of 20 years or above
H.Adequate organ function as defined by the following criteria
absolute neutrophil count (ANC) ≥ 1,500/mm3 hemoglobin level ≥ 9 g/dL platelet count ≥
000/mm3 total bilirubin ≤ 2 ULN or ≤5 ULN if caused by biliary obstruction and
achieving adequate drainage judged by investigator aspartate aminotransferase (AST)
alanine aminotransferase (ALT) ≤ 3 x ULN or ≤ 5.0×ULN in the presence of liver metastases
creatinine clearance rate (CCr) ≥ 50 mL/min (24-hour urine collection or calculated by
Cockroft-Gault formula; male: [(140 - age) × weight (kg)]/[72 × serum
creatinine(mg/dL)];female=male x 0.85
I.Patients with childbearing potential shall have effective contraception for both the
patient and his or her partner during the study

Exclusion Criteria

A. Other malignancy within the past 5 years except for adequately treated localized
skin cancer or carcinoma in situ
B.Active or uncontrolled infection
C.Significant medical conditions that is contraindicated to study medication or render
patient at high risk from treatment complications at physician discretion
D.Pregnant women or nursing mothers, or positive pregnancy test for women of
childbearing potential
E.History of active autoimmune disease within 3 years or use of steroid more than
prednisolone 10mg/day
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