NIPH Clinical Trials Search

JRCT ID: jRCT1011200013

Registered date:04/12/2020

Phase 1 trial of nivolumab and multisite radiotherapy for advanced gastric cancer (HGCSG2001)

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedgastric cancer
Date of first enrollment22/02/2021
Target sample size12
Countries of recruitment
Study typeInterventional
Intervention(s)patients recieve combination of immunotherapy (Nivolumab) and radiotherapy


Primary Outcomesafety
Secondary Outcomeprogression free survival overall survival response rate disease control rate response rate of non-irradiated lesion

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
Include criteria1. Signed and informed consent 2. >= 20 yeaes of age at time of study entry 3. Expected life expectancy >= 8 weeks 4. Histologically proven adenocarcinoma 5. advanced or recurrent gastric cancer 6. previously 7. WIth two or more mesurable disease (RECIST v 1.1) 8. ECOG PS 0 or 1 9. More than 14 days has passed from prior therapy 10. Hematological status: neutrophils(ANC)>=1.2x109/L; platelets >=75x109/L; haemoglobin >=9g/dL, Adequate renal function: Ccr >=40mL/min, Adequate liver function: serum bilirubin <=1.5 x upper normal limit(ULN), AST/ALT< 2.5 x the ULN for the reference lab unless liver metastases are present, in which case it must be =<5x ULN
Exclude criteria1. Active double cancer 2. Concurrent enrolment in another clinical study, unless it is an observational clinical study or during the follow-up period of an interventional study 3. Any unresolved toxicity CTCAE Grade >= 2 from previous anticancer therapy with the exception of alopecia, vitiligo and neuropathy 4. History of allogenic organ transplantation 5. severe pleural effusion or acsites 6. Interstitial pneumonia and pulmonary fibrosis 7. Severe complication 8. Infectious disease 9. Active viral hepatitis 10. Severe diabetes mellitus 11. Severe psychological disorders 12. Severe cardiovascular disease 13. Brain metastasis with clinical symptoms 14. systemic steroid use 15. Persons to be pregnant or to make pregnant 16. Contraindication to nivolumab 17. Participation in the clinical trial is determined as unsuitable

Related Information


Public contact
Name Shintaro Nakano
Address 2,nishi 7-chome,9jou,iwamizawa,Hokkaido Hokkaido Japan 068-8555
Telephone +81-126-22-1650
Affiliation Iwamizawa Municipal General Hospital
Scientific contact
Name Yoshito Komatsu
Address Kita 14, Nishi 5, Kita-Ku, Sapporo, Hokkaido Hokkaido Japan 060-8648
Telephone +81-11-716-1161
Affiliation Hokkaido University Hospital