SC-104

A multicenter, randomized, controlled trial of S-1 vs. Gemcitabine for treatment of untreated advanced pancreatic cancer.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221441

Enrollment

240

Registered

2011-04-25

Start date

2011-04-25

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

Untreated local advanced or distant metastatic pancreatic cancer

Interventions

investigational material(s) Generic name etc : S-1 INN of investigational material : S-1: tegafur, gimeracil, oteracil potassium Therapeutic category code : 422 Antimetabolic agents Dosage and Adminis

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients with untreated non-resectable local advanced or distant metastatic pancreatic cancer diagnosed by the pathological examination. 2) ECOG 0 or 1. 3) Patients with good bone marrow, liver and renal functions. 4) Patients who provided the written informed consent.

Exclusion criteria

Exclusion criteria: 1) Patients with diarrhea of CTCAE Grade 2 or above. 2) Patients with severe complications, brain metastases, multiple carcinoma, or active infection. 3) Patients with active pleural fluid or ascites. 4) Pregnancy and breast-feeding women or cases with a child-bearing plan.

Design outcomes

Primary

Measure	Time frame
Overall Survival Kaplan-Meier method is used for OS of FAS.	—

Secondary

Measure	Time frame
Safety, Objective Response Rate, Progression-Free Survival, Clinical Benefit Rate, QOL, Change of Pain, Change of Body Weight RECIST, CTCAE	—

Outcome results

None listed

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