A Randomized Phase II Study of S-1 plus Leucovorin versus S-1 alone in Patients with Gemcitabine-Refractory Advanced Pancreatic Cancer.

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221515

Enrollment

140

Registered

2011-07-15

Start date

2011-07-15

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

Pancreatic cancer

Interventions

investigational material(s) Generic name etc : S-1(tegafur + gimeracil + oteracil potassium), LV(Levofolinate calcium) INN of investigational material : S-1:tegafur, gimeracil, oteracil potassium, LV:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients must be diagnosed as invasive pancreatic ductal carcinoma - Patients with gemcitabine-refractory - Age: 20 years to 79 years - Eastern Cooperetive Oncology Group (ECOG) performance status (PS) of 0 or 1 - Sufficient oral intake - Written informed consent

Exclusion criteria

Exclusion criteria: - Diarrhea - History or presence of severe pulmonary disease - History or presence of severe heart disease - Uncontrolled or severe diabetes - Severe complications(e.g., severe enteritis, severe stomatitis, gastrointestinal ulcer)

Design outcomes

Primary

Measure	Time frame
Progression free survival(PFS) To compare the progression free survival (defined as the time from treatment to disease progression or death due to any cause) for S-1 puls LV versus S-1 alone.	—

Secondary

Measure	Time frame
Efficacy, Safety	—

Outcome results

None listed

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