Combination of checkpoint inhibitor and radiotherapy for recurrent gastric cancer after initial treatment with standard therapy.
- Conditions
- Gastric cancer
- Registration Number
- JPRN-UMIN000031508
- Lead Sponsor
- Fukushima Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 41
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease control rate (6 months)
- Secondary Outcome Measures
Name Time Method 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)