Health TrialsbyHealthPanel

Multi Omics Molecular Characteristics and Immunophenotyping of Lung Signet Ring Cell Carcinoma

ConditionSignet Ring Cell Carcinoma of the Lung
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorFirst People's Hospital of Hangzhou

About this trial

This study aims to reveal the molecular characteristics and immune microenvironmental profile of signet ring cell carcinoma of the lung (LSRCC) in the Chinese population through integrated multi-omics analyses. The project plans to enroll formalin-fixed paraffin-embedded (FFPE) tissue samples and paired adjacent tissues from 39 patients with previously untreated LSRCC to establish a Chinese LSRCC molecular database. Whole-exome sequencing (WES) will be used to analyze gene mutations, such as single nucleotide variants (SNVs), copy number variants (CNVs), and fusion events. RNA-seq will be used to screen for differentially expressed genes (DEGs) and perform immunophenotyping, while multiplex immunohistochemistry will be employed to quantify the tumor immune microenvironment (TIME). The successful implementation of this project is expected to identify novel molecular biomarkers specific to the Chinese LSRCC population, enhance understanding of the unique immune phenotypes within this group, and-combined with clinical follow-up-establish correlations between molecular/immune signatures and therapeutic efficacy assessments, thereby providing evidence-based medical support for subsequent personalized precision diagnosis and treatment of LSRCC in this population.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

This study will enroll adults (≥18 years) with newly diagnosed, histopathologically confirmed lung signet ring cell carcinoma (LSRCC) who have not received prior systemic anticancer therapy. All cases must have formalin-fixed paraffin-embedded (FFPE) tissue samples available. Additional inclusion criteria include measurable disease per RECIST v1.1 on contrast-enhanced CT, ECOG performance status 0-2, and adequate organ function. Patients with concurrent malignancies, prior exposure to any ALK-targeted agent, or known contraindications to TKI therapy are excluded.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Patients with specific TIME subtype and ALK fusion mutations (confirmed via RNA-seq and OncoKB annotation) will receive tyrosine kinase inhibitors (TKIs, e.g., alectinib or crizotinib) as first-line

    Drug

    Patients with specific TIME subtype and ALK fusion mutations (confirmed via RNA-seq and OncoKB annotation) will receive tyrosine kinase inhibitors (TKIs, e.g., alectinib or crizotinib) as first-line therapy. Clinical response will be assessed via RECIST v1.1 criteria using serial CT imaging (baseline, 8 weeks, and every 12 weeks thereafter). Correlative analyses will evaluate TKI efficacy in relation to TIME subtype, ALK fusion variant, and multi-omic signatures.

Treatment groups

39 Participants
are divided into 1 treatment group
Group A: Chinese LSRCC Multi-omics Cohort1 intervention

Trial outcomes

Primary outcomes

1

Week 8 Objective Response Rate (ORR) by RECIST v1.1 in ALK Fusion-Positive LSRCC Patients with Hybrid TIME Subtype

Objective Response Rate (ORR), defined as the proportion of patients achieving Complete Response (CR) or Partial Response (PR) per RECIST v1.1 criteria, assessed via contrast-enhanced CT at Week 8 following initiation of TKI therapy.

Time frame
8 weeks

Secondary outcomes

1

Progression-Free Survival (PFS)

Time from initiation of TKI therapy to the first documented radiologic disease progression (as per RECIST v1.1) or death from any cause, whichever occurs first.

Time frame
From baseline until disease progression or death (assessed up to 24 months).
2

Overall Survival (OS)

Time from initiation of TKI therapy to death from any cause.

Time frame
From baseline until death from any cause (assessed up to 36 months).
3

Duration of Response (DoR)

Among patients who achieve an objective response (CR or PR), the time from the first documented response to disease progression or death from any cause.

Time frame
From first response until progression or death (assessed up to 24 months).
4

Disease Control Rate (DCR) at Week 8

Proportion of patients achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD) per RECIST v1.1 at Week 8.

Time frame
8 weeks

Other outcomes

Sponsors and contacts

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First People's Hospital of Hangzhou

Lead sponsor

Zhejiang University

Collaborator

General Hospital of Ningxia Medical University

Collaborator

Source ClinicalTrials.gov
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