AzTrials
AzTrials

Low-dose RadiotherapyPhase 2NCT06331585

Effect of Low-dose Radiotherapy on Tumor Immune Microenvironment in Oligometastases of NSCLC After Immunotherapy

A Phase 2 study testing low dose radiotherapy in people with Low-dose Radiotherapy and Tumor Microenvironment, run by Hetian District People's Hospital at 1 site in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

The purpose of this phase Ⅱ trial was to investigate the effect of low-dose radiotherapy (LDRT) on the tumor immune microenvironment (TME) in oligometastasis, oligoprogression, and oligopersistence of non-small cell lung cancer (NSCLC) after immunotherapy. At least 20 participants will be enrolled in this study. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
low dose radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteChina
Study dates
18 Mar 2024to 18 Mar 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Agree to take pathologic biopsies of oligometastasis, oligoprogression, or oligopersistence lesions before and up to 24h after LDRT. And be willing and able to provide written informed consent/assent for the trial.
  • Patients with histologically or cytologically confirmed NSCLC.
  • Patient developed oligometastasis, oligoprogression or oligopersistence after standard immunotherapy.
  • Be ≥18 years of age on day of signing informed consent.
  • Be willing to undergo repeat biopsy of tumor lesions according to the study protocol.
  • Patients who have failed the standard therapy, or who are unsuitable for standard treatment, or refuse chemotherapy.
Show all 15Show fewer
  • At least one measurable lesion according to RECIST 1.1. A lesion that has previously received radiotherapy can be considered a target lesion only if this lesion is clearly progressed after radiotherapy.
  • The target lesions (irradiated lesions) are > 5cm in in diameter
  • ECOG 0-2.
  • Life expectancy of > 3 months.
  • Patients must have normal organ and bone marrow function as defined below: Total bilirubin </= 1.5 x upper limit of normal (ULN). Aminotransferase (AST) Serum Glutamic Oxaloacetic Transaminase (SGOT)/ Alanine Aminotransferase (ALT) Serum Glutamic-Pyruvic Transaminase (SGPT) <2.5 X institutional upper limit of normal (</= 5 X institutional ULN for subjects with liver metastases) *WBC >/= 3500/uL, ANC >/= 1500/uL *Platelets >/= 90K/ul *Hemoglobin >/= 9g/dL *Creatinine </= 1.5 x ULN, or creatinine clearance ≥ 50 ml/min（Cockcroft-Gault equation）. Coagulation: International Normalized Ratio (INR)≤ 1.5 × ULN, Partial thromboplastin time (PTT) ≤1.5 × ULN; left ventricular ejection fraction (LVEF) >/= 50% and QTcF (Fridericia's formula) ≤ 450ms
  • Patients has recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
  • Wash out period for chemotherapy is more than ≥ 4 weeks, for targeted small molecule therapy ≥ 5 half-lives; palliative radiotherapy must have been completed for at least ≥ 2 weeks, chest radiotherapy must have been completed for at least ≥ 4 weeks, and major surgery must have been completed for ≥ 4 weeks.
  • Subjects with no severe pulmonary ventilation dysfunction, no acute heart failure, and no contraindication to radiotherapy as judged by the radiotherapist. Subjects who agree to receive immunotherapy and radiotherapy treatment.
  • Subjects should agree to use an adequate method of contraception.

Who cannot join

  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis and/or spinal cord compression, etc.
  • With oncologic emergencies that require immediate treatment
  • EGFR/ALK/ROS-1 mutation or mutation status unknown.
  • Has evidence of interstitial lung disease or active and/or non-infectious pneumonitis (drug-induced pneumonia, radiation-induced pneumonia, etc.) requiring steroid therapy.
  • History of pulmonary fibrosis, pulmonary hypertension, severe irreversible airway obstruction disease
  • Patients with peripheral neuropathy.
Show all 12Show fewer
  • Significant heart disease or impairment of cardiac function
  • Fluid accumulating in the third space, such as pericardial effusion, pleural effusion and peritoneal effusion that remains uncontrolled by aspiration or other treatment
  • Known allergy to drugs or excipients, known severe allergic reaction to any of the PD-1 monoclonal antibodies
  • Severe infection within 4 weeks prior to the start of study treatment, including but not limited to hospitalization for infection, bacteremia, or severe pneumonia; treatment with oral or intravenous antibiotics within 2 weeks prior to the start of study treatment; patients receiving prophylactic antibiotic therapy (e.g., to prevent urinary tract infection or exacerbation of COPD) are eligible for this study.
  • Known or suspected active autoimmune disease (congenital or acquired) such as uveitis, enterocolitis, hepatitis, pituitary inflammation, vasculitis, nephritis, thyroiditis, etc. (patients with vitiligo, or resolved childhood asthma may be enrolled; patients with type I diabetes with good insulin control may also be enrolled)
  • Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Hetian District People's Hospital

    Hetian, Xinjiang Uygur Autonomous Region, 848000

Other trials in China

About this study

Official title: Phase II Trial of Low-dose Radiotherapy (LDRT) Affecting the Tumor Immune Microenvironment (TME) in Oligometastasis, Oligoprogression, and Oligopersistence of Non-small Cell Lung Cancer (NSCLC) After Immunotherapy.

The purpose of this phase Ⅱ trial was to investigate the effect of low-dose radiotherapy (LDRT) on the tumor immune microenvironment (TME) in oligometastasis, oligoprogression, and oligopersistence of non-small cell lung cancer (NSCLC) after immunotherapy. At least 20 participants will be enrolled in this study. All will take part at Hetian District People's Hospital.

Read the detailed description

LDRT targeting oligometastases has been shown to enhance anti-tumour immunity by reprogramming the TME, thereby improving the efficacy of immunotherapy. The aim of this study was to collect pathological tissues from oligometastasis, oligoprogression, and oligopersistence of NSCLC after immunotherapy before LDRT (5Gy/5f) and up to 24h after LDRT in order to apply multiplexed fluorescence immunohistochemistry (mIHC) for evaluation of the tumor immune microenvironment. This study will be able to investigate the effect of LDRT on TME in oligometastatic lesions of NSCLC after immunotherapy and assess the efficacy and safety of LDRT.

Being tested
low dose radiotherapy
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • low dose radiotherapyRadiation

    LDRT (5Gy/5f) of oligometastasis, oligoprogression, and oligopersistence of NSCLC after immunotherapy

Study groups in NCT06331585
Study groupRoleWhat they receive
Experimental armExperimentalExperimental: LDRT on oligometastasis, oligoprogression, and oligopersistence of NSCLC after immunotherapy 1. LDRT: Patient undergoes LDRT using a medical linear gas pedal (5Gy/5f) 2. Biopsy: Collect pathological tissues from oligometastasis, oligoprogression, and oligopersistence of NSCLC after immunotherapy before LDRT (5Gy/5f) and up to 24h after LDRT
Receives: Radiation: low dose radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Analysis of the tumor immune microenvironment

    mIHC: Multiplex fluorescence immunohistochemical analysis was performed on the collected pathological tissue samples(before LDRT (5Gy/5f) and up to 24h after LDRT) using equipment such as fluorescence microscope and flow cytometer. To reveal the effect of LDRT on the tumor immune microenvironment by detecting the expression of different immune markers.

    Measured: 12 months

Secondary outcomes (3)

  1. Number of participants with Adverse Events and/or Dose Limiting Toxicities as a Measurement of Safety and Tolerability of Low Dose Radiotherapy

    Number of participants with Adverse Events and/or Dose Limiting Toxicities as a Measurement of Safety and Tolerability of Low Dose Radiotherapy

    Measured: 48 months

  2. Progression Free Survival (PFS)

    Investigator assessed PFS according to RECIST v1.1. Progression free survival is defined as time of enrollment to first evidence of progressive disease up to 48 months after the enrollment

    Measured: 48 months

  3. Overall Survival (OS)

    OS is defined as the difference (in months) between the date of study enrollment to the date death due to any cause up to 48 months after the enrollment

    Measured: 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2024
  2. Study start18 Mar 2024
  3. Primary completion18 Mar 2025 (estimated)
  4. Study completion18 Mar 2026 (estimated)

Why it stopped: work commitments

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06331585
Sponsor's protocol ID
KY-2024004
Status last verified
Mar 2024
First submitted
19 Mar 2024
Last updated
25 Apr 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing low dose radiotherapy in people with Low-dose Radiotherapy and Tumor Microenvironment, run by Hetian District People's Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Analysis of the tumor immune microenvironment (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06331585.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in