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 |
Combination of checkpoint inhibitor and radiotherapy for recurrent gastric cancer after initial treatment with standard therapy.
CIRCUIT
Combination of checkpoint inhibitor and radiotherapy for recurrent gastric cancer after initial treatment with standard therapy.
CIRCUIT
Japan |
Gastric cancer
Gastrointestinal surgery | Radiology |
Malignancy
NO
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).
Safety,Efficacy
Disease control rate (6 months)
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)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
NO
NO
Institution is not considered as adjustment factor.
NO
No need to know
1
Treatment
Other |
Radiotherapy before administration of nivolumab
Dose: 22.5 Gy/5 fractions/5 days
20 | years-old | <= |
Not applicable |
Male and Female
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.
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.
40
1st name | Koji |
Middle name | |
Last name | Kono |
Fukushima Medical University Hospital
Department of Gastrointestinal Tract Surgery
960-1295
1 Hikarigaoka, Fukushima, Fukushima
024-547-1111
kojikono@fmu.ac.jp
1st name | Kosaku |
Middle name | |
Last name | Mimura |
Fukushima Medical University Hospital
Department of Gastrointestinal Tract Surgery
960-1295
1 Hikarigaoka, Fukushima, Fukushima
024-547-1111
kmimura@fmu.ac.jp
Fukushima Medical University
Ono Pharmaceutical Co.,ltd.
Bristol-Myers Squibb Company
Profit organization
Kanagawa Cancer Center
Fukushima Medical University
1 Hikarigaoka, Fukushima, Fukushima
024-547-1111
c-kiban@fmu.ac.jp
YES
NCT03453164
ClinicalTrials.gov
福島県立医科大学附属病院(福島県)
2018 | Year | 03 | Month | 01 | Day |
Unpublished
41
Completed
2018 | Year | 01 | Month | 19 | Day |
2018 | Year | 11 | Month | 16 | Day |
2018 | Year | 03 | Month | 01 | Day |
2021 | Year | 01 | Month | 31 | Day |
2021 | Year | 01 | Month | 31 | Day |
2018 | Year | 02 | Month | 28 | Day |
2021 | Year | 08 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035376