Low-dose Radiotherapy Combined With Conventional Fractionated Radiotherapy in Lung Cancer After Immunotherapy Resistance

NCT05906329 | Unknown

• 1 other identifier: YXLL-KY-2023（015）
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Cancer Patients

Keywords

lung cancer, radiotherapy, immunotherapy resistance

Outcome Measures

Primary Outcomes (1)

• 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.

  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 resistance

OTHER

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

Interventions

Low-dose radiotherapy combined with conventional fractionated radiotherapy RADIATION

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.

Low-dose radiotherapy combined with conventional radiotherapy after immunotherapy resistance

Eligibility Criteria

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

You may qualify if:

• \. Patients are able to understand the informed consent form, voluntarily participate and sign the informed consent form.
• \. Age range from 18 to 65 years old, regardless of gender.
• \. ECOG level 0-1; Expected life\>6 months.
• \. At least get into a liquid diet.
• \. No history of severe allergies.
• \. Hemoglobin ≥ 100 g/L, WBC ≥ 3.5 x10\~9/L, neutrophils ≥ 1.8 x10\~9/L, platelets ≥ 10 x10\~9/L; AST and ALT ≤ 2.5 × normal upper limit, AKP ≤ 2.5 × normal upper limit.
• \. Non small cell lung cancer (adenocarcinoma, large cell carcinoma, squamous carcinoma, adenosquamous carcinoma, sarcomatoid carcinoma) confirmed by cytology or histology.
• \. Complete clinical data.
• \. ≤ 10 primary and regional metastatic lymph nodes and distant metastatic lesions, and ≤ 5 organ metastases.
• \. Malignant tumor patients with immune therapy resistance (evaluated after 6-8 weeks of treatment and no improvement in clinical symptoms) without standard treatment options.
• \. There are measurable primary lesions, regional lymph node metastasis, and distant metastatic lesions.

You may not qualify if:

• \. Missing key patient information (pathological diagnosis, radiation dose, imaging examination, previous treatment plans, etc.).
• \. Refusal or lack of cooperation in research.
• \. Patients who have participated in other clinical studies/trials within three months.
• \. Patients with brain metastases.
• \. The researcher determines that there are any patients who are not suitable to participate in the study.
• \. Accompanied by severe infections.
• \. Serious liver disease (such as cirrhosis), kidney disease, respiratory disease or chronic system diseases such as uncontrollable diabetes and hypertension; Patients who cannot tolerate radiation therapy.
• \. Previous occurrence of immune related toxic side effects (immune myocarditis, pneumonia, etc.).
• \. Previous history of radiation therapy.

Sponsors & Collaborators

• Qianfoshan Hospital: 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)

• Yin L, Xue J, Li R, Zhou L, Deng L, Chen L, Zhang Y, Li Y, Zhang X, Xiu W, Tong R, Gong Y, Huang M, Xu Y, Zhu J, Yu M, Li M, Lan J, Wang J, Mo X, Wei Y, Niedermann G, Lu Y. Effect of Low-Dose Radiation Therapy on Abscopal Responses to Hypofractionated Radiation Therapy and Anti-PD1 in Mice and Patients With Non-Small Cell Lung Cancer. Int J Radiat Oncol Biol Phys. 2020 Sep 1;108(1):212-224. doi: 10.1016/j.ijrobp.2020.05.002. Epub 2020 May 15.

  PMID: 32417411 RESULT

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Pingping Hu, Dr.

  Deputy chief physician

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiandong 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: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: June 7, 2023
• First Posted: June 15, 2023
• Study Start: December 31, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2024
• Last Updated: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)