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Influence of regulatory T cells on resistance mechanisms to epidermal growth factor receptor inhibitors: an observational study

Influence of regulatory T cells on resistance mechanisms to epidermal growth factor receptor inhibitors: an observational study - INTREPID-i (INfluence of Treg on Resistance mechanism to EPIDermal growth factor receptor inhibitors) study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000009012
Enrollment
20
Registered
2012-11-01
Start date
2012-11-01
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

Lung cancer and colon cancer treated with epidermal growth factor receptor inhibitors

Interventions

None listed

Sponsors

Oita University Faculty Of Medicine Graduate School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.The study is initially limited to patients with adenocarcinoma in lung and colon. 2.All patients are required to be treated with a single agent of EGFR-TKI (gefitinib, erlotinib,afatinib) or EGFR-Ab (cetuximab, panitumumab). 3.Skin damage has to recover to <= Grade 1 or can be distinguish from the adverse effect of prior therapies 4.An Eastern Co- operative Oncology Group performance status of 0, 1 or 2. 5.All patients had adequate hepatic, renal, and bone marrow function. 6.All patients were required to give informed consent.

Exclusion criteria

Exclusion criteria: 1.Patients had a medical history of treatment with gefitinib, erlotinib,afatinib, cetuximab, or panitumumab. 2.The patient has received systemic chemotherapy within 21 days or therapeutic radiation therapy within 14 days prior to the first dose of study therapy. Palliative radiation is permitted. 3.Patients have severe complications, as active infection and poorly controlled diabetes. 4.Patients has allergy, which is expected to interrupt the study. 5.Pregnant women 6.Multiple primary cancer. 7.Patients regularly use corticosteroids and immunosuppressive drugs. Inhalation and topical use are permitted.

Design outcomes

Primary

MeasureTime frame
Relevance between Treg distribution in skin/circulation and progression free survival

Countries

Japan

Contacts

Public ContactKazuo Nishikawa

Oita University Faculty Of Medicine Graduate School of Medicine Department of Medical Oncology & Hematology

nishikawak@oita-u.ac.jp097-586-6275

Outcome results

None listed

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