Unique ID issued by UMIN | UMIN000017123 |
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Receipt number | R000019709 |
Scientific Title | Immunopotentiating therapy with Propagermanium in patients with untreatable advanced or metastatic gastric cancer. |
Date of disclosure of the study information | 2015/05/01 |
Last modified on | 2018/04/17 16:04:36 |
Immunopotentiating therapy with Propagermanium in patients with untreatable advanced or metastatic gastric cancer.
Immunopotentiating therapy with Propagermanium in patients with untreatable advanced or metastatic gastric cancer.
Immunopotentiating therapy with Propagermanium in patients with untreatable advanced or metastatic gastric cancer.
Immunopotentiating therapy with Propagermanium in patients with untreatable advanced or metastatic gastric cancer.
Japan |
Advanced or metastatic gastric cancer
Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Malignancy
NO
To evaluate the feasibility, safety, and efficacy of Propagermanium for advanced or metastatic gastric cancer.
Safety
Exploratory
Phase II
Overall survival
Adverse events, feasibility, disease control rate, progression free survival, proportion of treatment related death, and performance status.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
Propagermenium (30mg/day, every day)
20 | years-old | <= |
Not applicable |
Male and Female
1) Histologically confirmed gastric cancer
2) resistant /intolerable to other treatments
3) Measurable or non-measurable disease
4) Adequate oral intake
5) Age >= 20 years
6) Eastern Cooperative Oncology Group Performance status is 0,1,2.
7) Negative HBe antigen and no liver cirrhosis
8) Adequate renal function
9) No prior immunotherapy
10) Treatment in out-patient clinic is feasible.
11) Written informed consent
1) Active concomitant malignancy
2) Active infection
3) High fever (>38 degree) at registration
4) Pregnant, nursing or unwilling to practice contraception during the study
5) Poorly controlled diabetes mellitus
6) medication of steroid
7) Severe diabetes mellitus
8) Unstable angina or acute myocardial infarction within 6 months
9) Severe organ failure ( renal, hepatic pulmonary disease)
10) Active bleeding
11) Massive pleural effusion
15
1st name | |
Middle name | |
Last name | Mitsuru Sasako |
Hyogo College of Medicine
Surgery
1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan
0798-45-6767
msasako@hyo-med.ac.jp
1st name | |
Middle name | |
Last name | Shojiro Kikuchi |
Hyogo College of Medicine
Surgery
1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan
0798-45-6767
skikuchi@hyo-med.ac.jp
Hyogo College of Medicine
Hyogo College of Medicine
Self funding
NO
兵庫医科大学病院(兵庫県)
2015 | Year | 05 | Month | 01 | Day |
Unpublished
Completed
2015 | Year | 03 | Month | 31 | Day |
2015 | Year | 05 | Month | 01 | Day |
2017 | Year | 03 | Month | 31 | Day |
2018 | Year | 03 | Month | 31 | Day |
2018 | Year | 03 | Month | 31 | Day |
2018 | Year | 03 | Month | 31 | Day |
2015 | Year | 04 | Month | 13 | Day |
2018 | Year | 04 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019709
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