Cancer Patients
Conditions
Keywords
Cancer patients after immunotherapy failure
Brief summary
Response was evaluated according to the Guidelines for Response Criteria for Use in Trials Testing Immunotherapeutics (iRECIST) : ORR-To evaluate the objective effective rate of LDRT combined with SFRT and immunotherapy in patients with malignant tumors after immunotherapy resistance without standard regimens. PFS-To evaluate the progression-free survival (PFS) of patients with advanced malignant tumors after LDRT combined with SFRT and immunotherapy without standard regimens after immunotherapy resistance.DCR-To evaluate the proportion of patients with optimal response to LDRT and SFRT combined with immunotherapy to achieve complete response, partial response, or disease control after no standard regimen was available for immunotherapy resistance.HRQoL, AE and sAE-Evaluation of health related quality of life and safety of post-LDRT combined with SFRT and immunotherapy in patients with malignant tumors. To evaluate the benefit of patients in this trial.
Interventions
RADIATIONAt the same time, the original regimen of immunomaintenance therapy was continued, according to the frequency of the original immunization regimen once every 3 weeks until progress.
At the same time, the original regimen of immunomaintenance therapy was continued, according to the frequency of the original immunization regimen once every 3 weeks until progress.
Sponsors
Jiandong Zhang
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 1\. The patient understood, participated voluntarily and signed the informed consent 2\. Age 18-65 3\. Cytologically or histologically confirmed malignancy 4\. Complete clinical data 5\. The number of primary and regional metastatic lymph nodes and distant metastatic lesions was ≤10, and the number of organ metastases was ≤5. 6\. Patients with malignant tumors who are resistant to immunotherapy (the patient's disease progression is evaluated after 6-8 weeks of treatment without improvement of clinical symptoms), and no standard treatment options are available. 7\. Measurable primary lesions and regions
Exclusion criteria
* 1\. Missing key patient data 2\. Refusing or not cooperating with the study 3\. Patients who have participated in other clinical studies/trials within 3 months 4\. Patients with brain metastases 5\. Patients with any conditions that the investigator judged to be ineligible for study participation 6\. Patients with uncontrolled severe medical diseases who cannot tolerate radiotherapy 7\. Past immune-related side effects (immune myocarditis, pneumonia, etc.) 8\. Previous history of radiation therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR | Eighteen months | To evaluate the objective effective rate of LDRT combined with SFRT and immunotherapy in patients with malignant tumors after immunotherapy resistance without standard regimens. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS | Eighteen months | To evaluate the progression-free survival (PFS) of patients with advanced malignant tumors after LDRT combined with SFRT and immunotherapy without standard regimens after immunotherapy resistance. |
| DCR | Eighteen months | To evaluate the proportion of patients with optimal response to LDRT and SFRT combined with immunotherapy to achieve complete response, partial response, or disease control after no standard regimen was available for immunotherapy resistance. |
| HRQoL、AE、SAE | Eighteen months | Evaluation of health related quality of life and safety of post-LDRT combined with SFRT and immunotherapy in patients with malignant tumors. |
Countries
China
Contacts
Primary ContactJIANDONG ZHANG JD ZHANG, Dr
Outcome results
None listed