Clinical trial · Observational
Serum Exosomal miRNA Predicting the Therapeutic Efficiency in Lung Squamous Carcinoma
A Study on Serum Exosomal miRNA Predicting the Effective and Prognosis of Immunotherapy Combined With Chemotherapy in Pulmonary Squamous Carcinoma
NCT05854030CI-TRIAL-00066354unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Exosomes | — | UNRESOLVED | — |
| Lung Neoplasm | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Squamous Cell Carcinoma | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| collect plasma samples and clinical features | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- advanced lung squamous carcinoma
- description
- advanced pulmonary carcinoma with pathological diagnosis of squamous cell and are applied with first line treatment of anti-PD-L1 combined with chemotherapy
- interventionNames
- Diagnostic Test: collect plasma samples and clinical features
- label
- normol volunteers
- description
- 10 normol volunteers will be enrolled in the group
- interventionNames
- Diagnostic Test: collect plasma samples and clinical features
Primary outcomes (4)
- measure
- plasma exosomal miRNA level
- timeFrame
- Baseline up to 21 days
- description
- The expression levels of serum exosome micro RNA
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (11)
- RESULTWalsh 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 32670423
- RESULTHansen 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 26562503
- RESULTSacher 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 27310809
- RESULTRizvi 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 25765070
- RESULTLe 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 28596308
- RESULTYu 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.