Low-dose Radiotherapy Combined With Conventional Radiotherapy After Immunotherapy Failure

Cancer Patients Clinical Trial

— FL001  

Official title:

A Clinical Study of Low-dose Radiotherapy Combined With Conventional Radiotherapy in Patients With Malignant Tumors After Immunotherapy Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05547282
• Other study ID #: YXLL-KY-2022(074)
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: February 1, 2024

Study information

• Verified date: September 2022
• Source: Qianfoshan Hospital
• Contact: JIANDONG ZHANG JD ZHANG, Dr
• Phone: 13583123486
• Email: zhangjd165[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: February 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer Patients

Intervention

Radiation:
• 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.
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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital)16766 Jingshi Road, Jinan City	Jinan	In Shandong Province

Sponsors (1)

Lead Sponsor	Collaborator
Jiandong Zhang

Country where clinical trial is conducted

China, 

References & Publications (1)

Bates JE, Morris CG, Milano MT, Yeung AR, Hoppe BS. Immunotherapy with hypofractionated radiotherapy in metastatic non-small cell lung cancer: An analysis of the National Cancer Database. Radiother Oncol. 2019 Sep;138:75-79. doi: 10.1016/j.radonc.2019.06. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Eighteen months
Secondary	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.	Eighteen months
Secondary	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.	Eighteen months
Secondary	HRQoL?AE?SAE	Evaluation of health related quality of life and safety of post-LDRT combined with SFRT and immunotherapy in patients with malignant tumors.	Eighteen months