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

Study Overview

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

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.

Phase II, Open-label, Parallel 2-arm, Multi-center

DRUG: Gemcitabine 1000 mg
DRUG: Nab paclitaxel
DRUG: S1
DRUG: leucovorin
DRUG: Oxaliplatin

T5221

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2021-08-24	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-05-05
First Submitted that Met QC Criteria 2021-08-24	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-05-07
First Posted (ACTUAL) 2021-08-30	Results First Posted N/A	Last Verified 2024-09

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Sequential

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
OTHER: GASL arm eligible patients will receive gemcitabine 800 mg/m2 on day 1, nab-paclitaxel 125 mg/m2 on day 1, S-1 orally 60-100 mg/day [depending on patient's baseline body surface area (BSA)] on day 1 to 7 and leucovorin 30mg BID day 1 to 7 on in a 2-week cycle	DRUG: Gemcitabine 1000 mg Gemcitabine 800mg/m2 in N/S 250ml over 30 minutes (or fixed dose rate 10 mg/m2/min) IV infusion on day 1 repeated every 14 days. DRUG: Nab paclitaxel Nab-paclitaxel 125mg/m2 over 30 minutes IV infusion on day 1 repeated every 14 days, followed by Gemcitabine DRUG: S1 S-1 orally 60-100 mg/day day 1 to 7 on in a 2-week cycle. The dose of S-1 is defined as follows: * BSA < 1.25 m2: 60 mg/day * 1.25 m2 ≤ BSA < 1.5 m2: 80 mg/day * BSA ≥ 1.5 m2: 100 mg/day DRUG: leucovorin leucovorin 30mg BID day 1 to 7 on in a 2-week cycle
OTHER: GAP arm eligible patients will receive gemcitabine 800 mg/m2, nab-paclitaxel 125 mg/m2 and oxaliplatin 75mg/m2 on day 1 in a 2-week cycle.	DRUG: Gemcitabine 1000 mg Gemcitabine 800mg/m2 in N/S 250ml over 30 minutes (or fixed dose rate 10 mg/m2/min) IV infusion on day 1 repeated every 14 days. DRUG: Nab paclitaxel Nab-paclitaxel 125mg/m2 over 30 minutes IV infusion on day 1 repeated every 14 days, followed by Gemcitabine DRUG: Oxaliplatin Oxaliplatin 75mg/m2 in 250 mL of D5W over 120 minutes IV infusion on day 1 repeated every 14 days

Participant Group/Arm

Intervention/Treatment

OTHER: GASL arm

eligible patients will receive gemcitabine 800 mg/m2 on day 1, nab-paclitaxel 125 mg/m2 on day 1, S-1 orally 60-100 mg/day [depending on patient's baseline body surface area (BSA)] on day 1 to 7 and leucovorin 30mg BID day 1 to 7 on in a 2-week cycle

DRUG: Gemcitabine 1000 mg

Gemcitabine 800mg/m2 in N/S 250ml over 30 minutes (or fixed dose rate 10 mg/m2/min) IV infusion on day 1 repeated every 14 days.

DRUG: Nab paclitaxel

Nab-paclitaxel 125mg/m2 over 30 minutes IV infusion on day 1 repeated every 14 days, followed by Gemcitabine

DRUG: S1

S-1 orally 60-100 mg/day day 1 to 7 on in a 2-week cycle. The dose of S-1 is defined as follows: * BSA < 1.25 m2: 60 mg/day * 1.25 m2 ≤ BSA < 1.5 m2: 80 mg/day * BSA ≥ 1.5 m2: 100 mg/day

DRUG: leucovorin

leucovorin 30mg BID day 1 to 7 on in a 2-week cycle

OTHER: GAP arm

eligible patients will receive gemcitabine 800 mg/m2, nab-paclitaxel 125 mg/m2 and oxaliplatin 75mg/m2 on day 1 in a 2-week cycle.

DRUG: Gemcitabine 1000 mg

Gemcitabine 800mg/m2 in N/S 250ml over 30 minutes (or fixed dose rate 10 mg/m2/min) IV infusion on day 1 repeated every 14 days.

DRUG: Nab paclitaxel

Nab-paclitaxel 125mg/m2 over 30 minutes IV infusion on day 1 repeated every 14 days, followed by Gemcitabine

DRUG: Oxaliplatin

Oxaliplatin 75mg/m2 in 250 mL of D5W over 120 minutes IV infusion on day 1 repeated every 14 days

Primary Outcome Measures	Measure Description	Time Frame
Best objective response rate (ORR)	tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.	6 years

Secondary Outcome Measures	Measure Description	Time Frame
Disease control rate (DCR)	Defined as having complete response, partial response or stable disease at least 12 weeks.	6 years
Progression-free survival (PFS)	from the start date of study treatment to the date of progression disease or death.	6 years
Overall survival (OS)	from the start date of study treatment to the date of death.	6 years
Duration of response (DOR)	time from documentation of tumor response to disease progression.	6 years
Incidence of Treatment-related Adverse Events [Safety and Tolerability]	This study will utilize the NCI-CTCAE v5.0 for Adverse Event monitoring and reporting	6 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
20 Years

Accepts Healthy Volunteers:

A.Cytology or histology confirmed pancreatic adenocarcinoma with evidence of distant metastasis.Mixed component of other cell type (eg, adenosquamous, adenocarcinoma with neuroendocrine differentiation) is eligible but should notify PI before registration.
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:

A. Other malignancy within the past 5 years except for adequately treated localized cancer or carcinoma in situ;All patients with other malignancy within the past 5 years should notify PI before registration.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

China Medical University Hospital
National Cheng-Kung University Hospital
Kaohsiung Medical University Chung-Ho Memorial Hospital
Taichung Veterans General Hospital

Investigators

STUDY_CHAIR: Li-Tzong Chen, MD, Ph.D., National Health Research Institutes, Taiwan

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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