NCT05854030

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

April 3, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 11, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

May 11, 2023

Status Verified

March 1, 2023

Enrollment Period

1.3 years

First QC Date

April 3, 2023

Last Update Submit

May 10, 2023

Conditions

Lung NeoplasmSquamous Cell CarcinomaExosomes

Keywords

biomarker

Outcome Measures

Primary Outcomes (4)

  • plasma exosomal miRNA level

    The expression levels of serum exosome micro RNA

    Baseline up to 21 days

  • PD-L1

    the expression levels of PD-L1

    Baseline up to 21 days

  • Imaging data of lesions

    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

    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

Study Arms (2)

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

normol volunteers

10 normol volunteers will be enrolled in the group

Diagnostic Test: collect plasma samples and clinical features

Interventions

collect plasma samples and clinical featuresDIAGNOSTIC_TEST

8ml of peripheral blood need to be collected from pre- and post-treatment advanced pulmonary squamous carcinoma separately

advanced lung squamous carcinomanormol volunteers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TianjinCIH

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

Related Publications (11)

  • Walsh RJ, Soo RA. Resistance to immune checkpoint inhibitors in non-small cell lung cancer: biomarkers and therapeutic strategies. Ther Adv Med Oncol. 2020 Jul 3;12:1758835920937902. doi: 10.1177/1758835920937902. eCollection 2020.

    PMID: 32670423RESULT

  • Hansen AR, Siu LL. PD-L1 Testing in Cancer: Challenges in Companion Diagnostic Development. JAMA Oncol. 2016 Jan;2(1):15-6. doi: 10.1001/jamaoncol.2015.4685. No abstract available.

    PMID: 26562503RESULT

  • Sacher AG, Gandhi L. Biomarkers for the Clinical Use of PD-1/PD-L1 Inhibitors in Non-Small-Cell Lung Cancer: A Review. JAMA Oncol. 2016 Sep 1;2(9):1217-22. doi: 10.1001/jamaoncol.2016.0639.

    PMID: 27310809RESULT

  • Rizvi NA, Hellmann MD, Snyder A, Kvistborg P, Makarov V, Havel JJ, Lee W, Yuan J, Wong P, Ho TS, Miller ML, Rekhtman N, Moreira AL, Ibrahim F, Bruggeman C, Gasmi B, Zappasodi R, Maeda Y, Sander C, Garon EB, Merghoub T, Wolchok JD, Schumacher TN, Chan TA. Cancer immunology. Mutational landscape determines sensitivity to PD-1 blockade in non-small cell lung cancer. Science. 2015 Apr 3;348(6230):124-8. doi: 10.1126/science.aaa1348. Epub 2015 Mar 12.

    PMID: 25765070RESULT

  • Le DT, Durham JN, Smith KN, Wang H, Bartlett BR, Aulakh LK, Lu S, Kemberling H, Wilt C, Luber BS, Wong F, Azad NS, Rucki AA, Laheru D, Donehower R, Zaheer A, Fisher GA, Crocenzi TS, Lee JJ, Greten TF, Duffy AG, Ciombor KK, Eyring AD, Lam BH, Joe A, Kang SP, Holdhoff M, Danilova L, Cope L, Meyer C, Zhou S, Goldberg RM, Armstrong DK, Bever KM, Fader AN, Taube J, Housseau F, Spetzler D, Xiao N, Pardoll DM, Papadopoulos N, Kinzler KW, Eshleman JR, Vogelstein B, Anders RA, Diaz LA Jr. Mismatch repair deficiency predicts response of solid tumors to PD-1 blockade. Science. 2017 Jul 28;357(6349):409-413. doi: 10.1126/science.aan6733. Epub 2017 Jun 8.

    PMID: 28596308RESULT

  • Yu W, Hurley J, Roberts D, Chakrabortty SK, Enderle D, Noerholm M, Breakefield XO, Skog JK. Exosome-based liquid biopsies in cancer: opportunities and challenges. Ann Oncol. 2021 Apr;32(4):466-477. doi: 10.1016/j.annonc.2021.01.074. Epub 2021 Feb 4.

    PMID: 33548389RESULT

  • Mashouri L, Yousefi H, Aref AR, Ahadi AM, Molaei F, Alahari SK. Exosomes: composition, biogenesis, and mechanisms in cancer metastasis and drug resistance. Mol Cancer. 2019 Apr 2;18(1):75. doi: 10.1186/s12943-019-0991-5.

    PMID: 30940145RESULT

  • Correction: Correlation of plasma exosomal microRNAs with the efficacy of immunotherapy in EGFR / ALK wild-type advanced non-small cell lung cancer. J Immunother Cancer. 2020 May;8(1):e000376corr1. doi: 10.1136/jitc-2019-000376corr1. No abstract available.

    PMID: 32434787RESULT

  • Cazzoli R, Buttitta F, Di Nicola M, Malatesta S, Marchetti A, Rom WN, Pass HI. microRNAs derived from circulating exosomes as noninvasive biomarkers for screening and diagnosing lung cancer. J Thorac Oncol. 2013 Sep;8(9):1156-62. doi: 10.1097/JTO.0b013e318299ac32.

    PMID: 23945385RESULT

  • Zhang C, Chong X, Jiang F, Gao J, Chen Y, Jia K, Fan M, Liu X, An J, Li J, Zhang X, Shen L. Plasma extracellular vesicle derived protein profile predicting and monitoring immunotherapeutic outcomes of gastric cancer. J Extracell Vesicles. 2022 Apr;11(4):e12209. doi: 10.1002/jev2.12209.

    PMID: 35362262RESULT

  • Cordonnier M, Nardin C, Chanteloup G, Derangere V, Algros MP, Arnould L, Garrido C, Aubin F, Gobbo J. Tracking the evolution of circulating exosomal-PD-L1 to monitor melanoma patients. J Extracell Vesicles. 2020 Jan 7;9(1):1710899. doi: 10.1080/20013078.2019.1710899. eCollection 2020.

    PMID: 32002173RESULT

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Squamous Cell

Study Officials

  • Richeng Richeng, Postdoctor

    Tianjin Medical University Cancer Institute and Hospital

    STUDY CHAIR

Central Study Contacts

Richeng Jiang, Postdoctor

CONTACT

862223340123jiangricheng@tjmuch.com

Qin Chen, Doctor

CONTACT

+8615822048332ruozhuxuan@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2023

First Posted

May 11, 2023

Study Start

April 1, 2022

Primary Completion

July 31, 2023

Study Completion

August 31, 2023

Last Updated

May 11, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)