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Trial Title:
Low-dose Radiotherapy Combined With Conventional Radiotherapy After Immunotherapy Failure
NCT ID:
NCT05547282
Condition:
Cancer Patients
Conditions: Keywords:
Cancer patients after immunotherapy failure
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
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.
Description:
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.
Arm group label:
Low-dose radiotherapy combined with conventional radiotherapy after immunotherapy failure
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital)16766 Jingshi Road, Jinan City
Address:
City:
Jinan
Zip:
250013
Country:
China
Status:
Recruiting
Contact:
Last name:
JIANDONG ZHANG JD ZHANG
Phone:
13583123486
Email:
zhangjd165@sina.com
Start date:
October 1, 2022
Completion date:
February 1, 2024
Lead sponsor:
Agency:
Jiandong Zhang
Agency class:
Other
Source:
Qianfoshan Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05547282
