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

NCT05026905 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: T5221
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 4

Brief 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. This study 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.

Conditions

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

Keywords

Metastatic Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Disease control rate (DCR)

  6 years

• Progression-free survival (PFS)

  6 years

• Overall survival (OS)

  6 years

• Duration of response (DOR)

  6 years

• Incidence of Treatment-related Adverse Events [Safety and Tolerability]

  6 years

Study Arms (2)

GASL arm

OTHER

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. 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: Gemcitabine 1000 mg; Drug: Nab paclitaxel; Drug: S1; Drug: leucovorin

GAP arm

OTHER

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; Drug: Nab paclitaxel; Drug: Oxaliplatin

Interventions

Gemcitabine 1000 mg DRUG

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.

Also known as: Gemcitabine

GAP arm; GASL arm

Nab paclitaxel DRUG

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

Also known as: nab-paclitaxel

GAP arm; GASL arm

S1 DRUG

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

Also known as: S-1

GASL arm

leucovorin DRUG

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

Also known as: Calcium Folinate tablet

GASL arm

Oxaliplatin DRUG

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

GAP arm

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• absolute neutrophil count (ANC) ≥ 1,500/mm3 hemoglobin level ≥ 9 g/dL platelet count ≥ 100,000/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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Health Research Institutes, Taiwan: lead
• China Medical University Hospital: collaborator
• National Cheng-Kung University Hospital: collaborator
• Kaohsiung Medical University Chung-Ho Memorial Hospital: collaborator
• Taichung Veterans General Hospital: collaborator

Study Sites (4)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 800, Taiwan

Location

China Medical University Hospital

Taichung, 400, Taiwan

Location

Taichung Veterans General Hospital

Taichung, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 600, Taiwan

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; Taxes; 130-nm albumin-bound paclitaxel; S 1 (combination); Leucovorin; Oxaliplatin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Economics; Health Care Economics and Organizations; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Coordination Complexes; Organic Chemicals

Study Officials

• Li-Tzong Chen, MD, Ph.D.

  National Health Research Institutes, Taiwan

  STUDY CHAIR

• Yung-Yeh Su, M.D.

  National Health Research Institutes, Taiwan

  PRINCIPAL INVESTIGATOR

• Shang-Hung Chen, M.D.

  National Health Research Institutes, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2021
• First Posted: August 30, 2021
• Study Start: December 28, 2021
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (4)