Randomized phase II study of gemcitabine and S-1 combination therapy versus S-1 in patients with gemcitabine-refractory advanced pancreatic cancer

Randomized phase II study of gemcitabine and S-1 combination therapy versus S-1 in patients with gemcitabine-refractory advanced pancreatic cancer - Randomized phase II study of gemcitabine and S-1 combination therapy versus S-1 in patients with gemcitabine-refractory advanced pancreatic cancer

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007173

Enrollment

Registered

2012-02-01

Start date

2012-02-01

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

advanced pancreatic cancer

Interventions

A: Patients receive gemcitabine(1,000 mg/m2, day1,8) plus S-1(60-100 mg/day, day1-14) every 3 weeks. It is repeated until obvious evidence of disease progression, patient refusal, or unacceptable toxi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Diagnosed as pancreatic cancer 2)Recurrent or unresectable pancreatic cancer 3)Histologically proven invasive ductal pancreatic cancer 4)Refractory to gemcitabine monotherapy or gemcitabine combination therapy exclusive 5-FU chemotherapy (recurrent within 6 months after gemcitabine adjuvant therapy is eligible) 5)Gemcitabine chemotherapy over 4weeks 6)ECOG PS of 0,1 or 2 7)Sufficient oral intake 8)Aged over 20 years old 9)Adequate organ functions 10)Written informed consent

Exclusion criteria

Exclusion criteria: 1)With moderate or more pleural effusion/ ascites 2)Interstitial pneumonia or fibroid lung 3)Cardiac insufficiency or myocardial infarction within six months 4)Active bacterial or fungous infection 5)Uncontrollable diabetes mellitus 6)Psychosis or severe mental disorder 7)Severe drug allergy 8)Simultaneous or metachronous (within 3 years) double cancers, with the exception of intramucosal tumor curable with local therapy 9) Previous chemotherapy or radiotherapy against any other malignancies within 3 years 10)Over 6 months after adjuvant gemcitabine chemotherapy 11)With CNS metastas 12)Patients requiring the administration of flucytosine, phenytoin or warfarin potassium 13)Pregnant, lactating women or women of childbearing potential 14)Men who want to get partner pregnant 15)Inadequate physical condition, as diagnosed by primary physician

Design outcomes

Primary

Measure	Time frame
progression-free survival	—

Secondary

Measure	Time frame
response rate, overall survival, adverse events	—

Countries

Japan

Contacts

Public ContactMakoto Ueno

Kanagawa Cancer Center Division of hepatobiliary and pancreatic medical oncology

kantansui@kcch.jp045-391-5761

Outcome results

None listed

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