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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1011200013

Enrollment

Registered

2020-12-04

Start date

2021-02-22

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastric cancer

Interventions

patients recieve combination of immunotherapy (Nivolumab) and radiotherapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
safety	—

Secondary

Measure	Time frame
progression free survival overall survival response rate disease control rate response rate of non-irradiated lesion	—

Contacts

Public ContactShintaro Nakano

Iwamizawa Municipal General Hospital

shinakano123@gmail.com+81-126-22-1650

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026