The project to investigate mTOR inhibitor-induced immune modulation in subjects with renal cell cancer.

The project to investigate mTOR inhibitor-induced immune modulation in subjects with renal cell cancer. - Japanese m-TOR Immune Modulation Trial(J-TORIM)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000009662

Enrollment

Registered

2013-01-01

Start date

2013-01-01

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

advanced renal cell carcinoma

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Unresectable or metastatic renal carcinoma patients who were diagnosed from the results of cytological or pathological studies. 2.Patients who had more than one measurable lesions according on CT or MR imaging to the Response Evaluation Criteria in Soild Tumors (RECISTv.1.1). 3.Patients with aged 18 and over. 4.Patients with performance status 0-1 (ECOG). 5.Patients who does not observe a stromal shade in a lung by thorax CT. 6.Patients with an appropriate major organ function (liver, kidney, and myeloid). 7.Patients who meets all the following standards. FBS<=1.5 x ULN Total cholesterol<=400mg/dL Trigliceride<=5.0 x ULN 8.Patients with expected survival for 3 months or longer. 9.Patients with written informed consent from the patient (In the case of underage, from both the patient himself and legally acceptable representative ). 7.Patients who meets all the following standardses. FBS<=1.5 x ULN Total cholesterol<=400mg/dL Trigliceride<=5.0 x ULN 8.Patients with expected survival for 3 months or longer. 9.Patients with written informed consent from the patient.

Exclusion criteria

Exclusion criteria: 1.Patients with known hypersensitivity to temsirolimus or its metabolites (including sirolimus). 2.Female patients of childbearing potential (including male patients of planning to childbear ) and becoming pregnant. 3.Patients treated with m-TOR inhibitor or performed prior immunotherapy within 6 months. 4.Patients treated with systemic steroidal therapy or immunosuppressive drug. 5.Patients with brain metastasis. 6.Patients with active double cancers. 7.Patients with active infectious disease. 8.In addition, patients whom a doctor in judge unsuitable as a candidate patients of an examination.

Design outcomes

Primary

Measure	Time frame
Changes on the immune-relevant parameter by temsirolimus-induced immune modulation.	—

Countries

Japan

Contacts

Public ContactYoshihiro Wada

Faculty of Life Sciences, Kumamoto University Honjo 1-1-1 Kumamoto City, Kumamoto, Japan

yoshiwad@kumamoto-u.ac.jp096-344-2111

Outcome results