Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:40 AM
Ignite Modification Date:
2025-12-25 @ 3:40 AM
NCT ID:
NCT01149902
Eligibility Criteria:
Inclusion Criteria:
1. The patients with relapsed and refractory head and neck squamous cell carcinoma
2. 20 years and older
3. ECOG performance status 0-1
4. More than 4 weeks must have elapsed from the time of radiation therapy and the last dose of chemotherapy
5. Tumor lesions are accessible to intratumoral dendritic cells injection
6. Patients who are able to do oral ingestion
7. Patients must have normal organ and marrow functions as follows:
* Hb\>9.0 mg/dl
* Ht\>25%
* WBC\>4000/mm3
* Platelet count\>100,000/mm3
* T-Bil\<1.5mg/dl
* GOT\<x2.5 institutional upper limit of normal
* GPT\<x2.5 institutional upper limit of normal
* Creatinin\<1.5mg/dl
8. signed informed consent
Exclusion Criteria:
1. Less than 20 years
2. Patients who test positive for Hepatitis B virus, Hepatitis C virus or HIV.
3. Patients with clinically active infection
4. Patients with uncontrolled concurrent illness including cardiovascular disease, pulmonary disease, and bleeding tendency
5. Concomitant malignant diseases, brain metastases
6. Psychiatric illness
7. Treatment with steroids
8. Decision of unsuitableness by physician
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT01149902
Study Brief:
Protocol Section:
NCT01149902