Serum Exosomal miRNA Predicting the Therapeutic Efficiency in Lung Squamous Carcinoma

May 10, 2023 updated by: Tianjin Medical University Cancer Institute and Hospital

A Study on Serum Exosomal miRNA Predicting the Effective and Prognosis of Immunotherapy Combined With Chemotherapy in Pulmonary Squamous Carcinoma

This is an observational prospective bi-center study of 50 patients operated on advanced squamous cell carcinoma. The main aim is to investigate the efficacy of serum exosomal miRNA as a biomarker for predicting the therapeutic effect of immunotherapy combined with chemotherapy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PD-L1 Testing in guiding patient selection for PD-1/PD-L1 inhibitor therapy in Lung Cancer exhibits insufficient sensitivity and efficacy. The investigators aimed to identify specific serum exosomal miRNA biomarkers that are highly sensitive and stable for predicting the therapeutic effect of immunotherapy combined with chemotherapy. So that the clinicians could use the biomarker to better stratify patients and select potential immunotherapy-beneficial subgroups before clinical decisions.

We plan to enroll 50 patients with advanced treatment-naïve squamous cell carcinoma and 10 healthy people in the present study. Peripheral blood from the plasma of 10 healthy individuals and 50 pulmonary squamous cell carcinoma (SCC) patients will be collected before first-line treatment and after 2 cycles of anti-PD-L1 immunotherapy combined with chemotherapy.

Firstly, exosomal miRNAs extracted from peripheral blood will be analyzed through high-throughput RNA sequencing to identify specific exosomal miRNAs.

Secondly, through analyzing the PFS and OS follow-up data of patients, they are divided into different subgroups. We explore the value of early predicting efficacy of exosome miRNA basing on sequencing results.

Thirdly, we compared the exo-miRNA biomarker with the value of PD-L1 expression in predicting the efficacy of immunotherapy.

Lastly, we suggest exo-miRNA combined with PD-L1 as a biomarker combination in predicting anti-PD-L1 immunotherapy efficacy to better select the potential benefit population suitable for immunotherapy.

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China, 300060

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed as advanced lung squamous carcinoma by histopathology and be treated with anti-PD-L1 combined with chemotherapy

Description

Inclusion Criteria:

  1. Histology or cytology confirmed patients with stage IV squamous cell carcinoma of IASLC TNM (8th edition);
  2. Patients have not previously received first-line anti-tumor systemic therapy for advanced lung cancer;
  3. At least one measurable lesion according to the irRECIST 1.1 standard;
  4. Physical condition and organ function allow for systemic antitumor therapy, including standard chemotherapy and immunotherapy;
  5. Age ≥ 18 years at the time of signing the informed consent form;
  6. Estimated survival≥ 3 months;
  7. Patients can follow the planned schedule and actively cooperate in returning to the hospital for regular clinical follow-up and necessary treatment;
  8. It can provide the clinical data required for research and is willing to use the test data for further scientific research and commercial product development.

Exclusion Criteria:

  1. Other malignancies within the last 5 years (except adequately treated carcinoma in situ and basal or squamous cell skin cancer);
  2. The investigators judged that the patient also had other serious medical conditions that could affect follow-up and short-term survival;
  3. Any other medical condition and social/psychological problems which the investigator determines that the patient is not suitable to participate in this study;
  4. Contrast-enhanced MRI or contrast-enhanced CT for clinical follow-up is not acceptable;
  5. Have an active or previous auto-immune disease that is likely to recur;
  6. Other antineoplastic therapies were planned for the duration of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
advanced lung squamous carcinoma
advanced pulmonary carcinoma with pathological diagnosis of squamous cell and are applied with first line treatment of anti-PD-L1 combined with chemotherapy
Diagnostic test: collect plasma samples and clinical features
8ml of peripheral blood need to be collected from pre- and post-treatment advanced pulmonary squamous carcinoma separately
normol volunteers
10 normol volunteers will be enrolled in the group
Diagnostic test: collect plasma samples and clinical features
8ml of peripheral blood need to be collected from pre- and post-treatment advanced pulmonary squamous carcinoma separately

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
plasma exosomal miRNA level
Time Frame: Baseline up to 21 days
The expression levels of serum exosome micro RNA
Baseline up to 21 days
PD-L1
Time Frame: Baseline up to 21 days
the expression levels of PD-L1
Baseline up to 21 days
Imaging data of lesions
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Imaging data of the pulmonary and metastatic lesions of the patients are collected
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Objective response rate
Time Frame: From the start of systemic treatment date until the date of first documented disease progression or date of death from any cause, whichever came first, assessed up to 100 months
From the start of systemic treatment date until the date of first documented disease progression or date of death from any cause, whichever came first, assessed up to 100 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Collaborators

Tianjin Chest Hospital

Investigators

  • Study Chair: Richeng Richeng, Postdoctor, Tianjin Medical University Cancer Institute and Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Anticipated)

July 31, 2023

Study Completion (Anticipated)

August 31, 2023

Study Registration Dates

First Submitted

April 3, 2023

First Submitted That Met QC Criteria

May 10, 2023

First Posted (Estimate)

May 11, 2023

Study Record Updates

Last Update Posted (Estimate)

May 11, 2023

Last Update Submitted That Met QC Criteria

May 10, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCC-EV-2022

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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