Clinical trial · Observational
The Role of ctDNA Testing Plus AI-based Pathology in Resectable LSCC
Circulating Tumor DNA (ctDNA) Dynamic Monitoring Plus Artificial Intelligence (AI)-Based Pathology Predict the Efficacy of Chemoimmunotherapy in Resectable Lung Squamous Cell Carcinoma (LSCC)
NCT05778253CI-TRIAL-00064873recruitingClinicalTrials.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)
The goal of this observational study is to explore whether ctDNA dynamic monitoring plus AI-based pathology can more effectively predict the therapeutic effect of neoadjuvant chemoimmunotherapy for resectable lung squamous cell carcinoma, so as to accurately guide clinical diagnosis and treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Squamous Cell Carcinoma | Lung Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| WES and ctDNA detection | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with lung Squamous Cell Carcinoma receiving neoadjuvant chemoimmunotherapy
- interventionNames
- Diagnostic Test: WES and ctDNA detection
Primary outcomes (4)
- measure
- Pathologic completet response (pCR) rate
- timeFrame
- Up to 1 year
- description
- pCR rate is defined as the percentage of participants having an absence of residual tumor cells in resected lung specimens and lymph nodes following completion of neoadjuvant therapy.
- measure
- ctDNA resolution
- timeFrame
- Up to 2 years
- description
- ctDNA resolution is defined as the change or resolution in tumor-derived DNA found in the bloodstream from diagnosis to after neoadjuvant therapy and after surgery, correlated with pathologic complete response (pCR)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histopathology or cytology confirmed the lung squamous cell carcinoma * Age ranging from 18 to 75 * Agree to participate in this study and sign an informed consent form * Treatment-naive tumor * According to the American Joint Committee on Cancer (AJCC) eighth edition of the Lung Cancer Staging Manual, the clinical stage is stage II-IIIb resectable or potentially resectable tumor * Sufficient tissue/blood samples are available to meet research requirements * The ECOG PS score is 0-1 Exclusion Criteria: * Patients who cannot understand the content of the experiment and cannot cooperate, and those who refuse to sign the informed consent form * Non-squamous NSCLC * Unresectable IIIa-IIIb tumor * Patients with solid organ or blood system transplantation * Previous use of CTLA-4, PD-1, or PD-L1 immune checkpoint inhibitors * Patients with interstitial lung disease * Patients with acute or chronic infectious disease * Pregnant and lactating women * Patients who have undergone other clinical drug trials
References
Publications (0)
Data not yet available
No reference posted for this study.