Selective intra-arterial immunotherapy for Head and Neck Cancer

JRCT ID: jRCTs041220157

Registered date:08/03/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Head and Neck Cancer
• Date of first enrollment: 08/03/2023
• Target sample size: 3
• Study type: Interventional
• Intervention(s): The subject patient undergoes catheter insertion through the superficial temporal artery under local anesthesia. Then, an immune checkpoint inhibitor is injected into the catheter. Specifically, the patient will be catheterized with an Anthrone P-U catheter, and a steering microcatheter will also be considered. Nivolumab 20 mg (2 ml per vial) will be mixed with 18 ml of saline to make a total volume of 20 ml, which will be infused over 30 minutes.

Outcome(s)

Primary Outcome

Safety of Nivolumab Arterial Infusion Administration
(determined at 6 and 9 weeks after the start of the clinical study)

(Observation items)
Catheter insertion as a safety issue
Type, frequency, and severity of illnesses including complications during and after drug infusion (respiratory disorders, myasthenia gravis, myocarditis, myositis, etc.)
(Respiratory disorders, myasthenia gravis, myocarditis, myositis, liver dysfunction, colitis, small intestine inflammation, severe diarrhea, endocrine thyroid, pituitary, adrenal, nerve and brain disorders, type 1 diabetes, renal dysfunction, skin disorders, etc.)
Arterial inflammation and spasm, possibly associated with intra-arterial administration

Secondary Outcome

Tumor shrinkage as a clinical effect
Analysis of tumor tissue Foxp3-positive cells, CD8-positive T cells, etc. as ancillary research
Immune-related cell test (peripheral blood)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Head and neck cancer with recurrence or distant metastasis(any pathological type).Patients must have received anti-PD-1 antibodies (nivolumab and pembrolizumab).
(especially in patients with well-defined nutritional arteries such as the external carotid artery branches of the facial, lingual, and maxillary arteries)
2. Patients for whom standard surgical resection is not feasible
3. Staging according to UICC TNM Classification of Malignant Tumors, 7th Edition Head and neck cancer: cTxNxM0 or M1
4.Patients with a performance status (PS) of 0-2 (ECOG criteria)
5.Patients who are at least 20 years of age on the date of consent to participate in the study
6.Patients must be free of severe impairment of major organs (bone marrow, heart, lungs, liver, kidney, etc.) and meet the following criteria for laboratory values (within 4 weeks prior to Day 1)

7.AST (GOT), ALT (GPT): not more than 2.5 times the upper limit of the facility standard
8.Serum creatinine of patients with impaired renal function: 1.2 mg/dl or less eGFR 40 ml/min or more
9. Arterial blood oxygen saturation: 95%or more (room temperature) EKG: no abnormal findings requiring treatment
10. Patients with lesions to be evaluated for efficacy
11. Patients from whom tumor tissue samples can be obtained by biopsy
12.Patients who have given an explanation of this study using the consent document and obtained consent.

Exclude criteria

1. HIV antibody-positive patients
2.HCV antibody-positive patients
3.Patients who are HBs antigen positive or HBV-DNA is reported as "detected" by real-time PCR
4.Patients with autoimmune diseases (including pre-existing autoimmune diseases)
5.Patients with interstitial lung disease (including suspected interstitial lung disease)
6.Patients with a history of serious hypersensitivity to antibody products in the past
7. Patients with hypertension that is difficult to control despite taking multiple antihypertensives (systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg)
8. Patients with endocrine disorders that are difficult to control
9. Patients who have received or will receive a live vaccine or attenuated vaccine within 4 weeks prior to Day 1
10. Patients with active inflammatory bowel disease or other severe chronic gastrointestinal disease with diarrhea
11. Patients with type 1 diabetes mellitus or patients with diabetes mellitus with HbA1c of 6.5% or higher by JDS (Japanese Diabetes Society criteria) or 6.9% or higher by NGSP (international standard) at the time of registration despite continuous use of insulin or oral hypoglycemic agents
12. Patients with unstable angina (angina with onset or worsening within 3 weeks prior to Day 1) or a history of myocardial infarction within 6 months prior to Day 1
13.Patients with multiple cancers. Patients with multiple cancers are defined as synchronous multiple cancers and iatrogenic multiple cancers with a disease-free interval of 5 years or less. Carcinoma in situ (intraepithelial carcinoma) or intramucosal carcinoma that is considered curable by local treatment is not included in overlapping cancers.
14. Patients who have not received continuous systemic administration of corticosteroids, immunosuppressive or immunoenhancing drugs for more than 4 weeks prior to Day 1
15.Patients who have received immunotherapy (e.g., tumor vaccine) within 12 weeks prior to Day 1
16. Women who are pregnant or lactating (except when lactation has been discontinued and will not be resumed), or patients, regardless of gender, who are unable to consent to contraception using a condom or other contraceptive method from the time of consent until 6 months after completion of study drug administration (excluding postmenopausal women (1 year or more since the last menstruation) or women who have undergone surgical sterilization or men who have undergone surgical sterilization). Men who have undergone surgical sterilization are excluded. 17.)
17. Patients with infectious diseases, active inflammatory diseases, or suspected infectious diseases with clinical symptoms such as fever
18. Patients with mental disorders or dementia that would interfere with proper consent
19. Patients who require continued treatment with systemic steroids
20. Patients who have undergone transplantation therapy such as hematopoietic stem cell transplantation
21. Patients who have received any other investigational drug within 4 weeks prior to the start of treatment
22. Other patients whom the principal investigator or subinvestigator determines to be inappropriate to conduct this study.

Related Information

• Primary Sponsor: Ogawa Tetsuya
• Source(s) of Monetary Support: Central Japan International Medical Center
• Secondary ID(s): Nil known