Circulating Tumor DNA and T Cell Repertoire Predict Radiotherapeutic Outcomes in NSCLC Patients With Brain Metastasis

NCT05737589 | Unknown

• 1 other identifier: DTO-20230201
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Collection of ctDNA and TCR data to predict the efficacy and prognosis of brain radiotherapy in patients with brain metastases from non-small cell lung cancer (NSCLC) in a comprehensive manner

Conditions

Carcinoma, Non-Small-Cell Lung; Brain Metastases

Outcome Measures

Primary Outcomes (1)

• overall survival (OS)

  OS is defined as the time elapsed between the initiation of radiotherapy and mortality from any cause.

  February 13, 2023-February 13, 2024

Secondary Outcomes (2)

• progression-free survival (PFS)

  February 13, 2023-February 13, 2024

• intracranial PFS (iPFS)

  February 13, 2023-February 13, 2024

Study Arms (1)

Observation group

This is an observational study, no interventions will be applied to patients in the observation group, and only blood and cerebrospinal fluid ctDNA and TCR data of patients with brain metastases from non-small cell lung cancer treated with radiotherapy will be recorded to predict patient prognosis. Peripheral blood and CSF samples were collected at baseline, 24 h (T0), and 28 days (T28) after completion of radiotherapy and underwent deep sequencing of ctDNA and TCR. The 6-month response rates of brain metastases and systemic lesions were evaluated based on Response Evaluation Criteria in Solid Tumors version 1.1 for further study.

Radiation: Whole-brain radiotherapy

Interventions

Whole-brain radiotherapy RADIATION

Radiotherapy is administered to the patient's brain lesions, and the subject's specific treatment plan is developed by two specialized physicians.

Also known as: Stereotactic radiotherapy

Observation group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A group of non-small cell lung cancer patients with brain metastasis who have never received radiotherapy

You may qualify if:

• Age \> 18 years
• Patients must have histologically or cytologically confirmed NSCLC and imaging-confirmed primary non-small cell lung cancer with brain metastases
• ECOG PS score of 0-2
• At least 1 lesion meeting RECIST 1.1 target lesion (TL) criteria at baseline. Must have baseline assessment imaging of the tumor by CT or MRI scan within 28 days prior to treatment
• No prior radiation therapy to the tumor, including but not limited to whole brain radiotherapy, prophylactic brain irradiation, stereotactic radiation therapy, etc.
• Major organ function indicators meet the criteria for conventional radiation therapy Adequate organ and bone marrow function is defined as follows
• Hemoglobin ≥ 9.0 g/dL
• absolute neutrophil count ≥ 1.5 × 109 / L
• Platelet count ≥ 100 × 109 / L
• Serum bilirubin ≤ 1.5 × the upper limit of normal (ULN). The above criteria were not applied to patients diagnosed with Gilbert's syndrome, but these patients were allowed to be enrolled after consultation between the study physician and their primary care physician.
• Alanine aminotransferase ALT or aspartate aminotransferase AST ≤ 2.5 × ULN
• Creatinine clearance (CL) \> 40 mL/min calculated or actually measured according to the Cockcroft-Gault method (based on actual body weight) Men. Creatinine CL = Body weight (kg) × (140 - age) (mL/min) 72 x serum creatinine (mg/dL) Females. Creatinine CL = Body weight (kg) × (140 - age) × 0.85 (mL/min) 72 × serum creatinine (mg/dL)
• Female subjects of childbearing age must exclude pregnancy
• Life expectancy \>12 weeks
• Body weight \>30Kg

You may not qualify if:

• History of allogeneic organ transplantation
• Active or previously documented autoimmune or inflammatory disease (including inflammatory bowel disease \[e.g., colitis or Crohn's disease\], diverticulitis (except diverticular disease), systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener's syndrome \[granulomatous vasculitis, Graves' disease, rheumatoid arthritis, pituitary inflammation, uveitis, etc.\])
• History of active primary immunodeficiency
• Other malignancies within the last 3 years.
• Presence of uncontrolled co-morbidities including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmias, active interstitial lung disease, a severe chronic gastrointestinal disease with diarrhea or mental illness that limits compliance with study requirements, significantly increases the risk of AE or affects the patient's life/ social conditions
• Active infection at the time of treatment, including tuberculosis (clinical assessment includes history, physical examination, imaging findings, and tuberculosis screening consistent with local clinical practice), hepatitis B (known hepatitis B surface antigen positive \[HBsAg\] result), hepatitis C virus (HCV) or human immunodeficiency virus (HIV 1/2 antibody positive). Patients with previous hepatitis B virus (HBV) infection or cured HBV infection (defined as the presence of positive hepatitis B core antibodies and negative HBsAg) may participate in this study. patients with positive HCV antibodies who are negative for HCV ribonucleic acid (RNA) by polymerase chain reaction only may participate in this study.
• Stage IV NSCLC according to the 8th edition of the International Society for the Study of Lung Cancer Thoracic Oncology Staging Manual
• Histological findings of NSCLC with mixed small cell component

Sponsors & Collaborators

• Xiaorong Dong: lead

Study Sites (1)

Union hospital

Wuhan, Hubei, 430000, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Brain Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Xiaorong Dong, Dr.

  Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  STUDY CHAIR

Central Study Contacts

Xiaorong Dong, Dr.

CONTACT

13986252286; xiaorongdong@hust.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor/Chief Physician

Study Record Dates

• First Submitted: February 12, 2023
• First Posted: February 21, 2023
• Study Start: February 13, 2023
• Primary Completion: February 13, 2024
• Study Completion: October 1, 2024
• Last Updated: February 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)