Low-dose Radiotherapy Combined With Conventional Radiotherapy After Immunotherapy Failure

NCT ID: NCT05547282

Last Updated: 2022-09-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2024-02-01

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.

Conditions

Cancer Patients

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Low-dose radiotherapy combined with conventional radiotherapy after immunotherapy failure

The chest, abdomen and pelvis were located by enhanced CT, and the target area was delineated. The lesions were visible lymph nodes with short diameter ≥1cm, and there were metastases confirmed by two associate chief physicians by enhanced MR and PET/CT examination results.

The primary lesion, the largest metastatic lesion or the lesion causing symptoms were selected and divided into 1.8-2Gy/F,40Gy-60Gy. For the remaining lesions, at least one easily evaluated and measurable lesion was selected as the observation lesion, and the unselected lesions (≤10 lesions) were given 1.6Gy/f, 1f/w, 4-6 times.

Immunotherapy regimens are administered according to the specific dose and interval of the original immunization regimen, such as concurrent chemotherapy or antiangiogenic drug therapy regimens. He used Nivolumab, Pembrolizumab, Troripalimab and Camrelizumanb.

Immunotherapy was performed at a frequency of 3 weeks in combination with radiotherapy until progression.

Group Type: OTHER

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.

Intervention Type: 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.

Interventions

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.

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiandong Zhang

OTHER

Sponsor Role: lead

Responsible Party

Jiandong Zhang

Chief physician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

PINGPING HU HU, Dr

Role: PRINCIPAL_INVESTIGATOR

Deputy chief physician

Locations

The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital)16766 Jingshi Road, Jinan City

Jinan, In Shandong Province, China

Site Status: RECRUITING

Countries

China

Central Contacts

JIANDONG ZHANG JD ZHANG, Dr

Role: CONTACT

zhangjd165@sina.com

13583123486 ext. 8926-8118

Facility Contacts

JIANDONG ZHANG JD ZHANG

Role: primary

zhangjd165@sina.com

13583123486

References

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.

Reference Type: RESULT

PMID: 31252297 (View on PubMed)

Other Identifiers

YXLL-KY-2022(074)

Identifier Type: -

Identifier Source: org_study_id