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Clinical and immunological analysis on the effect of LEM in the adoptive immunotherapy using autologous activated lymphocytes in patients with incurable cancer

Clinical and immunological analysis on the effect of LEM in the adoptive immunotherapy using autologous activated lymphocytes in patients with incurable cancer - LEM on AIT for Cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000012283
Enrollment
20
Registered
2013-12-01
Start date
2014-01-01
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

Incurable cancer

Interventions

LEM 1800mg/day, twice a day, orally, 4weeks

Sponsors

Kawasaki Medical School
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Histologically-defined panreatic cancer 2) Measurable lesion 3) on-going AIT 4) Age 20-80 5) PS 0-2 6) Estimated prognosis >= 3 months 7) Sufficient organ function WBC>4,000/mm3, <12,000/mm3 NE>2,000/mm3 PLT>100.000/mm3 Hg>10.0g/dl GOT/GPT<Normal range x 2 Bil<1.5mg/dl Creat<1.5mg/dl 8) Written informed consent 9) No pregnancy

Exclusion criteria

Exclusion criteria: 1) Autoimmune disease 2) Uncontrollable complications including infection, diabetes, hypertension, ischemic heart disease, cerebral infarction, interstitial pneumonitis, cancer pain 3) Pregnancy 4) Allergy 5) General symptoms including dyspnea, jaundice, edema, effusions, clamp, paralysis, fracture, difficult for out-patient 6) Steroid or immunosuppressive agents 7) Other unacceptable reasons

Design outcomes

Primary

MeasureTime frame
Immunological activity

Secondary

MeasureTime frame
QOL, safety

Countries

Japan

Contacts

Public ContactYoshiyuki YAMAGUCHI

Kawasaki Medical School Department of Clinical Oncology

shogo@med.kawasaki-m.ac.jp086-462-1111

Outcome results

None listed

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