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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name