UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031508 |
|---|---|
| Receipt number | R000035376 |
| Scientific Title | Combination of checkpoint inhibitor and radiotherapy for recurrent gastric cancer after initial treatment with standard therapy. |
| Date of disclosure of the study information | 2018/03/01 |
| Last modified on | 2021/08/18 15:56:21 |
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Basic information
Public title
Combination of checkpoint inhibitor and radiotherapy for recurrent gastric cancer after initial treatment with standard therapy.
Acronym
CIRCUIT
Scientific Title
Combination of checkpoint inhibitor and radiotherapy for recurrent gastric cancer after initial treatment with standard therapy.
Scientific Title:Acronym
CIRCUIT
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastrointestinal surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and efficacy of nivolumab (anti-PD-1 antibody), which is approved as tertiary therapy, and neoadjuvant short-term limited local radiotherapy in patients with unresectable recurrent gastric cancer who progressed (intolerance or PD) after standard treatment (primary and secondary chemotherapy) and have more than one lesion assessable in diagnostic imaging (one lesion must be >=2cm).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Disease control rate (6 months)
Key secondary outcomes
1) Median survival time (6 months)
2) Incidence of treatment-emergent adverse events (6 months)
3) Local control rate (6 months)
4) Expression of PD-L1 and MHC class I on tumor cells, number of CD8 positive lymphocytes in tumor microenvironment (These will be conducted by immunohistochemistry only for participants with available samples.)
5) Peak plasma HMGB-1, IL-1beta, IL-10, IFN-gamma concentration (At the time of registration, 2 weeks, 6 weeks, 10 weeks, and 6 months)
6) The rate of regulatory T-cell population in peripheral blood (At the time of registration, 2 weeks, 6 weeks, 10 weeks, and 6 months)
7) The rate of antigen-specific cytotoxic T lymphocyte in peripheral blood (At the time of registration, 2 weeks, 6 weeks, 10 weeks, and 6 months)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Radiotherapy before administration of nivolumab
Dose: 22.5 Gy/5 fractions/5 days
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Unresectable recurrent gastric cancer with progression (intolerance or PD) after standard treatment (primary and secondary chemotherapy).
2) More than one measurable lesion defined by RECIST guideline version 1.1 in diagnostic imaging (whole-body contrast-enhanced CT or PET-CT) within 14 days before entry, with at least one lesion >=2 cm.
3) Age: 20 =<
4) ECOG performance status (PS): 0-2
5) No contraindication for nivolumab (anti-PD-1 antibody) administration.
6) No contraindication for radiotherapy.
7) The most recent laboratory results within 14 days before study entry fulfill the following. However, if the laboratory results for study entry do not fall within 7 days before the first administration of nivolumab, the blood test must be performed again within 7 days before the administration to check if the results fulfill the following. The use of G-CSF or blood transfusion within 14 days before the laboratory testing is not allowed.
WBC >=3000/micro liter(ul), neutrophil >=1500/ul, hemoglobin >=9.0g/dl, platelets >=100,000/ul, total bilirubin <=2.0 times the institutional standard upper limit (ISUL), AST (GOT) and ALT (GPT) <=3.0 times ISUL (in case with liver metastasis, <=5.0 times ISUL), serum creatinine <=1.5 times ISUL or creatinine clearance >=60 ml/min calculated with Cockcroft-Gault equation.
Male Ccr = [(140-age)*body weight(kg)]/[72*serum creatinine(mg/dl)]
Female Ccr = 0.85*[(140-age)*body weight(kg)]/[72*serum creatinine(mg/dl)]
8) Expected survival >=3 months.
9) Written informed consent obtained before entry to the study.
Key exclusion criteria
1) No tumor lesions to be irradiated.
2) History of other cancers (intraepithelial cancer of uterine cervix, fully treated basal cell carcinoma of skin, malignant tumors treated before >=5 yrs and w/o recurrence are excluded).
3) Past severe hypersensitive reaction to antibody (Ab) drugs.
4) Use of immunosuppressant drugs or adrenocortical hormone (predonine or prednisolone (PDN/PSL) equivalent >=15 mg/day).
5) Active autoimmune diseases or history of recurrent autoimmune diseases. Patients (Pts) with type-1 diabetes, hypothyroid controlled with hormone replacement therapy, dermatosis without need for systemic therapy (for example, vitiligo, psoriasis, alopecia) are eligible.
6) History of interstitial pneumonia or pulmonary fibrosis diagnosed with imaging studies (CT is preferred) or clinical findings.
7) Presence of severe disease or pathology.
8) Pts during pregnancy or lactation.
9) Fertile female pts w/o intention to practice contraception.
10) Fertile male pts w/o intention to practice contraception during and for 7 months after the study, if the partners are fertile females.
11) Prohibited pre-treatment.
Within 56 days before entry: radioactive drugs (exclude those intended for testing or diagnosis)
Within 28 days before entry: systemic adrenocortical hormone (excludes temporary use or PDN/PSL equivalent of <15 mg/day), immunosuppressant drugs, anti-cancer drugs, adhesive treatment of pleura or pericardium, surgery with general anesthesia, use of unapproved drugs.
Within 14 days before entry: surgery with local or superficial anesthesia.
12) Concurrent participation in other clinical trials/studies (excludes those w/o intervention).
13) Positivity in HIV-1 Ab test, HIV-2 Ab test, or HTLV-1 Ab test.
14) History of treatment using ONO-4538, anti-PD-1 Ab, anti-PD-L1 Ab, anti-PD-L2 Ab, anti-CD137 Ab, anti-CTLA-4 Ab, or other Ab or drugs intended for T-cell regulation.
15) Pts whom the physicians in the study consider inappropriate for entry.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Kono |
Organization
Fukushima Medical University Hospital
Division name
Department of Gastrointestinal Tract Surgery
Zip code
960-1295
Address
1 Hikarigaoka, Fukushima, Fukushima
TEL
024-547-1111
kojikono@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Kosaku |
| Middle name | |
| Last name | Mimura |
Organization
Fukushima Medical University Hospital
Division name
Department of Gastrointestinal Tract Surgery
Zip code
960-1295
Address
1 Hikarigaoka, Fukushima, Fukushima
TEL
024-547-1111
Homepage URL
kmimura@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Ono Pharmaceutical Co.,ltd.
Bristol-Myers Squibb Company
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kanagawa Cancer Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukushima Medical University
Address
1 Hikarigaoka, Fukushima, Fukushima
Tel
024-547-1111
c-kiban@fmu.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
NCT03453164
Org. issuing International ID_1
ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
福島県立医科大学附属病院（福島県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
41
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 01 | Month | 19 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 16 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2021 | Year | 01 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 28 | Day |
Last modified on
| 2021 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035376
