Randomized phase II study of Gemcitabine and S-1 combination therapy versus S-1 in patients with Gemcitabine-refractory unresectable advanced Pancreatic Cancer

Randomized phase II study of Gemcitabine and S-1 combination therapy versus S-1 in patients with Gemcitabine-refractory unresectable advanced Pancreatic Cancer - Randomized phase II study of GS vs. S-1 in patients with Gem-refractory unresectable advanced Pancreatic Cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000011806

Enrollment

116

Registered

2013-09-19

Start date

2013-09-20

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

unresectable advanced Pancreatic Cancer

Interventions

Control arm:S-1 q6w Patients receive S-1 alone (80-120mg/day, day1-28) every 6 weeks. It is repeated until obvious evidence of Disease Progression, patient refusal, or unacceptable toxicity. Testin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Unresectable pancreatic cancer(without Recurrent cancer) 2)Age 20- 3)PS(ECOG) 0-1 4)Refractory Gem monotherapy or Gem combination therapy 5)Over 2 weeks after previous Gem chemotherapy 6)Sufficient oral intake 7)Metastatic pancreatic adenocarcinoma with measurable lesion according to RECSTver 1.1 8)Biliary drainage was applied adequately in patients with obstructive jaundice 9)Adequate organ functions 10)Written informed consent

Exclusion criteria

Exclusion criteria: 1)Patients who have previously administered 5-FU including S-1 2)Severe complications 3)Simultaneous or metachronous (within 5 years) double cancers, with the exception of intramucosal tumor curable with local therapy 4)Severe Gem hypersensitivity 5)Patients who have not undergone radiotherapy 6)Active infections 7)Patients with HBs antigen-positive or with HCV antibody-positive 8)Patients who have previous history of radiotherapy to the chest 9)Uncontrollable watery diarrhea 10)Presence of metastasis in central nervous system 11)Severe mental disorders 12)Pregnant or lactating women, or women with known or suspected pregnancy and men who want let to pregnancy 13)Required to continue to take flucytosine, phenytoin, and warfarin 14)Patients seems inadequate for this study by investigators

Design outcomes

Primary

Measure	Time frame
Progression-free survival	—

Secondary

Measure	Time frame
Overall survival, Disease Control Rate, Response Rate, Relative Dose Intensity, Adverse Events, Time to Treatment failure	—

Countries

Japan

Contacts

Public ContactMinoru Shigekawa

Osaka University Graduate School of Medicine Department of Gastroenterology and Hepatology

m-shigekawa@gh.med.osaka-u.ac.jp06-6879-3621

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026