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

JRCT ID: jRCT1011200013

Registered date:04/12/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: gastric cancer
• Date of first enrollment: 22/02/2021
• Target sample size: 12
• Study type: Interventional
• Intervention(s): patients recieve combination of immunotherapy (Nivolumab) and radiotherapy

Outcome(s)

• Primary Outcome: safety

Secondary Outcome

progression free survival
overall survival
response rate
disease control rate
response rate of non-irradiated lesion

Key inclusion & exclusion criteria

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

Include criteria

1. 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 criteria

1. 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

• Primary Sponsor: Komatsu Yoshito
• Source(s) of Monetary Support: Hokkaido Gastrointestinal Cancer Study Group:HGCSG