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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-17

Study Completion Date

2021-08-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pancreatic Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AS：Nanoparticle albumin-bound paclitaxel，S-1

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.

Group Type EXPERIMENTAL

nanoparticle albumin-bound paclitaxel

Intervention Type DRUG

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.

S1

Intervention Type DRUG

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.

AG：Nanoparticle albumin-bound paclitaxel，Gemcitabine

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.

Group Type ACTIVE_COMPARATOR

nanoparticle albumin-bound paclitaxel

Intervention Type DRUG

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.

Gemcitabine

Intervention Type DRUG

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

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Gemcitabine

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

Intervention Type DRUG

Other Intervention Names

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nab-paclitaxel Abraxane ABI-007

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No