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A phase II feasibility trial of Gemcitabine Hydrochloride and Krestin combination therapy in pancreatic cancer after surgery.

A phase II feasibility trial of Gemcitabine Hydrochloride and Krestin combination therapy in pancreatic cancer after surgery. - A phase II feasibility trial of Gemcitabine Hydrochloride and Krestin combination therapy in pancreatic cancer after surgery.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000003751
Enrollment
20
Registered
2010-06-30
Start date
2010-07-01
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

Gemcitabine Hydrochloride 1000 mg/m2 as Gemcitabine by drip infusion for 30 minutes Once a week for 3 weeks One course takes 4 weeks Maximum 6 courses Krestin 3 g per day 3 times per day D

Sponsors

Kyoto University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Patients with invasive ductal pancreatic cancer. 2)Patients with resection of the primary lesion and final findings stage III or IVa. 3)Patients who is between 20 and 80 years old at the time of enrollment. 4)Patients with ECOG Performance Status Scale of 0 or 1. 5)Patients without receiving chemotherapy, radiation therapy and immunotherapy including the treatment for the other carcinoma. 6)Patients who can take medicine orally. 7)Patients who maintain function of main organ in clinical test within 14 days before enrollment. 8)Patients with starting the immunochemotherapy within 2 weeks after enrollment. 9)Patients who have given consent to participate in this clinical study.

Exclusion criteria

Exclusion criteria: 1) Active double cancer. 2) Patients with severe myelosuppression. 3) Patients who receiving radiation therapy to the chest. 4) Patients with severe infection. 5) Patients with pulmonary fibrosis or interstitial lung disease. 6) Pregnant patients. 7) Patients with insanity or psychological symptom.

Design outcomes

Primary

MeasureTime frame
Disease-free survival

Secondary

MeasureTime frame
1) Overall survival 2) Incidence of adverse event

Countries

Japan

Contacts

Public ContactKyoichi Takaori

Kyoto University Hospital Department of Hepato-Pancreatic Surgery & Transplantation

takaori@kuhp.kyoto-u.ac.jp

Outcome results

None listed

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