Clinical trial NCT05547282: Low-dose Radiotherapy Combined With Conventional Radiotherapy After Immunotherapy Failure
Official title: A Clinical Study of Low-dose Radiotherapy Combined With Conventional Radiotherapy in Patients With Malignant Tumors After Immunotherapy Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer Patients
Keywords: Cancer patients after immunotherapy failure
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2022-09-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: ORR
timeFrame: Eighteen months
Secondary outcomes:
measure: PFS
timeFrame: Eighteen months
measure: DCR
timeFrame: Eighteen months
measure: HRQoL、AE、SAE
timeFrame: Eighteen months
Other outcomes:
Locations:
city: Jinan
country: China
facility: The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital)16766 Jingshi Road, Jinan City
state: In Shandong Province
Study officials:
affiliation: Deputy chief physician
name: PINGPING HU HU, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.2019.06.004. Epub 2019 Jun 25.