Low-dose Radiotherapy Combined With Conventional Radiotherapy After Immunotherapy Failure (FL001)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer Patients
• Intervention / Treatment: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: JIANDONG ZHANG JD ZHANG, Dr; Phone Number: 8926-8118 13583123486; Email: zhangjd165@sina.com

Study Locations

• China
  • In Shandong Province
    • Jinan, In Shandong Province, China, 250013
      • Recruiting
      • The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital)16766 Jingshi Road, Jinan City
      • Contact: JIANDONG ZHANG JD ZHANG; Phone Number: 13583123486; Email: zhangjd165@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Jiandong Zhang
• Investigators: Principal Investigator: PINGPING HU HU, Dr, Deputy chief physician

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2022
• Primary Completion (Anticipated): February 1, 2024
• Study Completion (Anticipated): February 1, 2024

Study Registration Dates

• First Submitted: September 13, 2022
• First Submitted That Met QC Criteria: September 16, 2022
• First Posted (Actual): September 21, 2022

Study Record Updates

• Last Update Posted (Actual): September 21, 2022
• Last Update Submitted That Met QC Criteria: September 16, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Cancer patients after immunotherapy failure
• Other Study ID Numbers: YXLL-KY-2022(074)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No