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Phase I trial of adjuvant chemotherapy with modified S-1 and propagermanium for pancreatic cancer

Phase I trial of adjuvant chemotherapy with modified S-1 and propagermanium for pancreatic cancer - Phase I trial of adjuvant chemotherapy with modified S-1 and propagermanium for pancreatic cancer

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000017715
Enrollment
10
Registered
2015-07-01
Start date
2015-07-01
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

pancreatic cancer

Interventions

TS-1 &lt
1.25m2, 80mg/body 1.25m2&lt
and&lt
1.5m2, 100mg/body 1.5m2&lt
, 120mg/body day1-28, q2w, x6 propagerumanium 30mg/day day1-28, q2w, x6

Sponsors

Osaka University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Histologically proven pancreatic adenocarcinoma 2)Gross complete resection (R0) 3)Age above 20 years 4)Status of 0 or 1 5)Adequate hematologic, hepatic and renal function 6)Good oral intake 7)Start therapy after operation within 4 weeks later and 12 weeks 8)Written informed consent

Exclusion criteria

Exclusion criteria: 1)Non curative operation 2)Active concomitant malignancy 3)History of severe anaphylaxies 4)Severe complications, such as heart failure, renal failure, liver failure, watery diarrhea, paresis of intestine, ileus and severe diabetes mellitus 5)With the jaundice or cirrhosis 6)Active infection 7)Pregnant or pregnant possibility 8)Severe mental disorder 9)Inappropriate

Design outcomes

Primary

MeasureTime frame
safety

Countries

Japan

Contacts

Public ContactDaisaku Yamada

Osaka University Hospital Division of HBP surgery and Transplantation

dyamada@gesurg.med.osaka-u.ac.jp06-6879-3251

Outcome results

None listed

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