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A I/II phase study of chemotherapy using irinotecan plus L-OHP plus S-1 treatment (SOXIRI) for unresectable advanced pancreatic cancer

A I/II phase study of chemotherapy using irinotecan plus L-OHP plus S-1 treatment (SOXIRI) for unresectable advanced pancreatic cancer - A phase I/II study of chemotherapy(SOXIRI)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000012975
Enrollment
30
Registered
2014-01-27
Start date
2014-01-27
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

Irinotecan is administered with 90 min intravenous infusion on day 1,15 every 4 weeks. L-OHP is administered with 120 min intravenous infusion on day 1,15 every 4 weeks. S-1 is taken orally on day

Sponsors

the university of tokushima
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1)unresectable invasive or reccurence advanced pancraatic carcinoma (2)first line treatment (3)Patients must be >=20 years old and <=80 years old (4)ECOG Performance Status must be 0 or 1. (5)The following criteria must be satisfied in laboratory tests. 1) Hemoglobin >= 9.0 g/dL 2) White blood cell count >=3,000/mm3 ,Neutrophil count >=1,500/mm3 3)Platelet count >=75,000mm3 4)Total bilirubin <=one and a half times as many as average level baseline 5)AST,ALT,ALP<= two and a half times as many as average level baseline 6) Serum Creatinine <=average level baseline (6)Life expectancy > 90 days. (7)Patients or legal representative must have signed the consent form.

Exclusion criteria

Exclusion criteria: (1) infusion of blood products within 7days (2) not first line treatment (3) severe Allergie (4) much ascites or pleural effusion (5) infection (6) diarrea (7) ileus (8) neuropathy (9) severe heart disorder (10) neuropsychiatric disorder (11) idiopathic pulmonary fibrosis or Idiopathic interstitial pneumonia (12) brain metastasis (13) pregnancy case (14) unsuitable case

Design outcomes

Primary

MeasureTime frame
MTD and DLT and RD

Countries

Japan

Contacts

Public Contacttakayama tetsuji

the university of tokushima department of gastroenterology

takayama@tokushima-u.ac.jp088-633-9116

Outcome results

None listed

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