An interventional study of Low-dose radiotherapy combined with conventional fractionated radiotherapy in Cancer Patients, sponsored by Qianfoshan Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-06-15.
Sponsored by Qianfoshan Hospital · Not applicable, Interventional, and Treatment
Pre-clinical and clinical studies have shown that low-dose radiation therapy has good immune regulatory effects, activates different anti-tumor immune pathways, and regulates tumor stroma to better promote T cell infiltration. Conventional fractionated radiotherapy increases antigen release and presentation, and stimulates immune cells. In theory, the combination of the two can reverse immune resistance. Our study aims to clarify the efficacy and safety of low-dose radiotherapy combined with conventional fractionated radiotherapy in reversing immune therapy resistance for patients with non-small cell lung cancer, including objective response rate (ORR), progression free survival time (PFS), disease control rate (DCR), health-related quality of life assessment (HRQoL), and incidence of adverse events (AEs).
This study is a researcher initiated, prospective, single arm, open clinical study.
Patients with non-small cell lung cancer who have undergone first-line or multi-line immunotherapy and have no standard treatment option after resistance are recruited in Department of Radiotherapy in the First Affiliated Hospital of Shandong First Medical University. Patients who meet the conditions shall be treated after signing a written informed consent form. Radiotherapy localization was performed through enhanced CT, and the target area was delineated. The lesion included the primary lesion and lymph nodes with a visible short diameter of ≥ 1cm, and there was metastasis confirmed by two deputy chief physicians based on enhanced MR and PET/CT examination results.
The primary lesion, the largest metastatic lesion, or the lesion causing symptoms are selected and performed conventional fractionated radiation of 1.8-2Gy/f, 40Gy-60Gy. For the remaining lesions, at least one easily assessable and measurable lesion should be selected as the observation lesion. Unselected lesions (≤ 10) should be given 1.6Gy/f, 1f/w, 4-6 times in total.
The immunotherapy regimen is implemented according to the specific dose and interval of the original immunotherapy regimen, such as synchronous combination chemotherapy or anti angiogenic drug therapy.
Immunotherapy is combined with radiotherapy at a frequency of once every 3 weeks until progression.
The attending physician is responsible for developing personalized follow-up plans based on the patient's personal situation, daily diagnosis and treatment routines, and standards.
Evaluate the incidence of ORR, PFS, DCR, HRQoL, AE, and sAE according to the guidelines for response criteria for use in trials testing immunotherapeutics (iRECIST) to evaluate the patient's degree of benefit in this trial.
Regarding the determination of immunotherapy resistance, if the tumor does not respond to initial immunotherapy and does not respond after more than 6 weeks of exposure to immune drugs, primary resistance may occur and imaging is needed to confirm the disease progression again. If two or more deputy chief physicians evaluate and determine the disease progression, immunotherapy resistance may occur. On the other hand, if the drug exposure time is more than 6 months, the tumor does not respond, and the acquired drug resistance may occur, including the new drug-resistant mutant derived from the tumor and the changes in the tumor microenvironment. The disease progress also needs to be re determined by imaging. If the disease progress is determined after the evaluation of more than two deputy chief physicians, the immunotherapy drug resistance occurs.
The quality control of all stages of clinical trials will be strictly implemented, including relevant evaluation indicators, participants, and a complete management system will be established.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's planned enrollment of 20 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Qianfoshan Hospital is the lead sponsor of 140 studies on the registry; 73 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients are able to understand the informed consent form, voluntarily participate and sign the informed consent form.
Exclusion Criteria:
Missing key patient information (pathological diagnosis, radiation dose, imaging examination, previous treatment plans, etc.).
By using enhanced CT to locate the chest, abdomen, and pelvis, the target area was delineated. The lesion was a visible lymph node with a short diameter of ≥ 1cm, and there was metastasis confirmed by two deputy chief physicians based on enhanced MR and PET/CT examination results. Select the primary lesion, the largest metastatic lesion, or the lesion causing symptoms, and perform routine segmentation (1.8-2Gy/f, 40Gy-60Gy). For the remaining lesions, at least one easily assessable and measurable lesion should be selected as the observation lesion. Unselected lesions (≤ 10) should be given 1.6Gy/f, 1f/w, 4-6 times in total. The immunotherapy plan is carried out according to the specific dose and interval of the original immune plan. Usually, immunotherapy is combined with radiotherapy at a frequency of once every 3 weeks until progression.
Radiation: Low-dose radiotherapy combined with conventional fractionated radiotherapy
Select the primary lesion, the largest metastatic lesion, or the lesion causing symptoms, and perform routine segmentation (1.8-2Gy/f, 40Gy-60Gy). For the remaining lesions, at least one easily assessable and measurable lesion should be selected as the observation lesion. Unselected lesions (≤ 10) should be given 1.6Gy/f, 1f/w, 4-6 times in total.
ORR
To evaluate the objective effective rate of low-dose radiotherapy combined with conventional fractionated radiotherapy and immunotherapy in patients with non-small cell lung cancer after immunotherapy resistance without standard regimens.
Time frame: Eighteen months
PFS
To evaluate the progression-free survival (PFS) of patients with advanced malignant tumors after low-dose radiotherapy combined with conventional fractionated radiotherapy and immunotherapy without standard regimens after immunotherapy resistance.
Time frame: Eighteen months
DCR
To evaluate the proportion of patients with optimal response to low-dose radiotherapy and conventional fractionated radiotherapy combined with immunotherapy to achieve complete response, partial response, or disease control after no standard regimen was available for immunotherapy resistance.
Time frame: Eighteen months
HRQoL、AE、SAE
Evaluation of health related quality of life and safety of post- low-dose radiotherapy combined with conventional fractionated radiotherapy and immunotherapy in patients with non-small cell lung cancer.
Time frame: Eighteen months
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Qianfoshan Hospital