The goal of this clinical trial is to find a new radioimmunotherapy regimen for advanced malignancies with multiple metastatic after standard treatment failure/drug resistance. The main questions it aims to answer is: the safety and efficacy of the new regimen for advanced multiple metastatic solid tumors standard treatment failure/drug resistance, and explore the impact on immune function. Participants will receive the combination of radiotherapy and immunotherapy.
More effective treatment regimens remain to be explored for advanced malignancies with multiple metastatic after standard treatment failure/drug resistance. The combination of radiotherapy and immunotherapy is considered to be a promising therapeutic strategy. Studies showed the efficacy of PRaG (PD-1 inhibitor, Radiotherapy and GM-CSF) treatment and stereotactic radiotherapy (SBRT) combined with low-dose radiotherapy (LDRT) for advanced tumors. Therefore, the investigators designed a new radioimmunotherapy regimen, including SBRT, LDRT , PD-1/PD-L1 inhibitor, and GM-CSF. This study aimed to evaluate the safety and efficacy of the new regimen for advanced multiple metastatic solid tumors standard treatment failure/drug resistance, and explore the impact on immune function.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
38
(1) SBRT 8Gy×3f, (2) LDRT 2Gy ×3f, PD-1/L1 inhibitor, periodically, until the disease progresses or intolerable toxic side effects, (4) GM-CSF, 200ug/QD, subcutaneous injection, the first course of treatment for 7 days.
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
RECRUITINGAdverse event rate
The proportion of treatment-related toxicities cases to the total evaluable cases, assessed according to CTCAE 5.0 criteria.
Time frame: 6 weeks
Objective response rate
Proportion of patients whose tumor volume has shrunk to a predetermined value and can maintain the minimum time limit.
Time frame: 6 weeks
Disease control rate
Proportion of patients who achieved remission (PR+CR) or stable lesion (SD) after treatment.
Time frame: 6weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.