Low-dose Radiotherapy Combined With Conventional Radiotherapy After Immunotherapy Failure

NCT05547282 | Unknown

• 1 other identifier: YXLL-KY-2022(074)
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Cancer patients after immunotherapy failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• PFS

  Eighteen months

• DCR

  Eighteen months

• HRQoL、AE、SAE

  Eighteen months

Study Arms (1)

Low-dose radiotherapy combined with conventional radiotherapy after immunotherapy failure

OTHER

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.

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. 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.

Low-dose radiotherapy combined with conventional radiotherapy after immunotherapy failure

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. The patient understood, participated voluntarily and signed the informed consent
• \. Age 18-65
• \. Cytologically or histologically confirmed malignancy
• \. Complete clinical data
• \. The number of primary and regional metastatic lymph nodes and distant metastatic lesions was ≤10, and the number of organ metastases was ≤5.
• \. 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.
• \. Measurable primary lesions and regions

You may not qualify if:

• \. Missing key patient data
• \. Refusing or not cooperating with the study
• \. Patients who have participated in other clinical studies/trials within 3 months
• \. Patients with brain metastases
• \. Patients with any conditions that the investigator judged to be ineligible for study participation
• \. Patients with uncontrolled severe medical diseases who cannot tolerate radiotherapy
• \. Past immune-related side effects (immune myocarditis, pneumonia, etc.)
• \. Previous history of radiation therapy

Sponsors & Collaborators

• Jiandong Zhang: lead

Study Sites (1)

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

Jinan, In Shandong Province, 250013, China

RECRUITING

Related 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.2019.06.004. Epub 2019 Jun 25.

  PMID: 31252297 RESULT

Study Officials

• PINGPING HU HU, Dr

  Deputy chief physician

  PRINCIPAL INVESTIGATOR

Central Study Contacts

JIANDONG ZHANG JD ZHANG, Dr

CONTACT

13583123486; zhangjd165@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: September 21, 2022
• Study Start: October 1, 2022
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: September 21, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)