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

P

Peking University

Status and phase

Unknown
Phase 2

Conditions

Pancreatic Cancer

Treatments

Drug: Gemcitabine
Drug: nanoparticle albumin-bound paclitaxel
Drug: S1

Study type

Interventional

Funder types

Other

Identifiers

NCT03636308
ASAG01

Details and patient eligibility

About

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.

Full description

Advanced pancreatic ductal adenocarcinoma (PDAC) is an aggressive and chemo-resistant disease with extremely low 5-year survival rate. Gemcitabine has been the cornerstone of metastatic PDAC treatment for more than a decade , although survival benefit was very poor. Nab-paclitaxel added to gemcitabine has showed improving survival and overall response rate vs gemcitabine alone in metastatic PDAC first-line treatment in the MPACT phaseIII study, which represents one of the standards of care in advanced PDAC therapy. S-1 is an oral 5-fluorouracil (5-FU) prodrug, and shown to be non-inferior to gemcitabine on OS for unresectable pancreatic cancer. Meanwhile, adjuvant chemotherapy with S-1 monotherapy was found to significant prolong survival of pancreatic cancer patients when compared with gemcitabine. This study is to explore the efficacy and safety of nab-paclitaxel plus S-1(AS) and nab-paclitaxel plus gemcitabine(AG) as first-line treatment in advanced pancreatic ductal adenocarcinoma (PDA) with primary tumor nonexcision in Chinese patients.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Signed informed-consent form.
  • Age no less than 18 years.
  • Histologically confirmed locally advanced or metastatic pancreatic ductal adenocarcinoma, with RECIST measurable lesions.
  • Eastern Cooperative Oncology Group (ECOG) 0-1 with life expectation of no less than 12 weeks.
  • Patients must have received no previous chemotherapy or investigational therapy for the treatment of locally advanced or metastatic disease.
  • At least 4 weeks since completion of the last operation except for diagnostic biopsy.
  • At least 4 weeks since completion of radiotherapy to lesions.
  • Not suitable for local treatment.
  • Adequate liver/bone marrow function.
  • Human Chorionic Gonadotropin (HCG) test negative for female with contraception measure until 3 months after study end.
  • Compliant, and can be followed up regularly.

Exclusion criteria

  • Received chemotherapy or investigational therapy for the treatment of locally advanced or metastatic disease.
  • Pregnant or breast-feeding female, or not willing to take contraception measures during study.
  • Serious infection requiring antibiotics intervention during recruitment.
  • Allergic to study drug.
  • More than grade 1 neuropathy.
  • Uncontrolled brain metastasis or mental illness.
  • Congestive heart failure, uncontrolled cardiac arrhythmia, etc.
  • Other malignancy within 5 years.
  • Can't be followed up or obey protocol.
  • Ineligible by the discretion of the investigator.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

AS:Nanoparticle albumin-bound paclitaxel,S-1
Experimental group
Description:
Nanoparticle albumin-bound paclitaxel is given at 125 mg/m2 intravenously on day 1 of each 14 day cycle. 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.
Treatment:
Drug: S1
Drug: nanoparticle albumin-bound paclitaxel
AG:Nanoparticle albumin-bound paclitaxel,Gemcitabine
Active Comparator group
Description:
Nanoparticle albumin-bound paclitaxel is given at 125 mg/m2 intravenously on day 1 and 8 of each 21 day cycle. Gemcitabine is given at 1000mg/m2 intravenously on day 1 and 8 of each 21 day cycle.
Treatment:
Drug: nanoparticle albumin-bound paclitaxel
Drug: Gemcitabine

Trial contacts and locations

1

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Central trial contact

Jun Zhou

Data sourced from clinicaltrials.gov

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