Unique ID issued by UMIN | UMIN000031324 |
---|---|
Receipt number | R000035754 |
Scientific Title | Clinical trial of nivolumab in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck cancer after six months who finished platinum-based chemotherapy |
Date of disclosure of the study information | 2018/02/19 |
Last modified on | 2022/08/20 09:43:12 |
Clinical trial of nivolumab in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck cancer after six months who finished platinum-based chemotherapy
Clinical trial of nivolumab in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck cancer after six months who finished platinum-based chemotherapy
Clinical trial of nivolumab in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck cancer after six months who finished platinum-based chemotherapy
Clinical trial of nivolumab in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck cancer after six months who finished platinum-based chemotherapy
Japan |
Head and Neck squamous cell carcinoma
Oto-rhino-laryngology |
Malignancy
NO
The effect of treatment, who received nivolumab in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck cancer after six months who finished platinum-based chemotherapy
Safety,Efficacy
Overall Survival
1) Progression Free Survival
2) Quality of Life score
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Intravenous nivolumab is administered at
a dose of 3 mg per kilogram of body weight every 2 weeks. Every 2 weeks of nivolumab as one course, patients receive nivolumab until disease progression, unacceptable toxic effects.
20 | years-old | <= |
75 | years-old | >= |
Male and Female
1) Patients in Recurrent or Metastatic after six months Squamous Cell Carcinoma of the Head and Neck who finished platinum-based chemotherapy
2) Histological proven squamous cell carcinoma of the head and neck
3) Primary site, maxillary sinus, oral cavity, epipharynx, oropharynx, hypopharynx or larynx
4) Age 20-75 years
5) Performance status (PS) 0-1
6) Adequate organ functions defined as indicated below before registration in 14 days
(1)WBC >= 3,500 /mm3 , WBC <= 12,000 /mm3
(2)neutrophil >= 2,000 /mm3
(3)Plt >= 100,000 /mm3
(4) Hb>= 9.0 g/ dL
(5) T.Bil <= 1.5 mg/dL
(6) AST(GOT) , ALT(GPT) <= 100 IU/L
(7) Cr < 1.2 mg/dL
7) Written informed consent
1) Patients with a past history of severe drug allergy of nivolumab and similar drug
2) Patients with a symptomatic brain metastasis and meningeal metastasis
3) Histological proven primary unknown squamous cell carcinoma, salivary gland cancer, non-squamous cell cancer.
4) Patients with a symptomatic autoimmune disease or history of Autoimmune disease.
5) Patients with infection
6) Patients with Gastrointestinal disease (Intestinal paralysis, Bowel obstruction)
7) Patients with Interstitial pneumonia or Pulmonary fibrosis
8) Uncontrolled diabetes
9) Uncontrolled heart disorder
10) Sever liver damage
11) Patients with diarrhea
12) Pregnant or lactating women or women of childbearing potential
13) Male expecting partner's pregnancy
14) Inadequate physical condition, as diagnosed by attending physician
50
1st name | Kiyoaki |
Middle name | |
Last name | Tsukahara |
Tokyo Medical University
Division of Otorhinolarygology, Head and neck Surgery
1600023
6-7-1 Nishi-shinjuku, Shinjukuku, Tokyo 160-0023 Japan
03-3342-6111
tsuka@tokyo-med.ac.jp
1st name | isaku |
Middle name | |
Last name | Okamoto |
Tokyo Medical University
Division of Otorhinolarygology, Head and neck Surgery
1600023
6-7-1 Nishi-shinjuku, Shinjukuku, Tokyo 160-0023 Japan
03-3342-6111
isaku@tokyo-med.ac.jp
Tokyo Medical University
Tokyo Medical University
Self funding
Tokyo Medical University Institutional Review Board
6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo
0333426111
Adm_IRB@tokyo-med.ac.jp
NO
2018 | Year | 02 | Month | 19 | Day |
Unpublished
Completed
2018 | Year | 02 | Month | 14 | Day |
2017 | Year | 12 | Month | 26 | Day |
2018 | Year | 02 | Month | 15 | Day |
2020 | Year | 12 | Month | 31 | Day |
2018 | Year | 02 | Month | 15 | Day |
2022 | Year | 08 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035754
Research Plan | |
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Registered date | File name |
2018/02/23 | ③プラチナ6M以降ニボルマブ実施計画書.doc |
Research case data specifications | |
---|---|
Registered date | File name |
2018/02/23 | 登録適格性確認票 ニボルマブ6M以降.docx |
Research case data | |
---|---|
Registered date | File name |