MRD-guided Prognosis Prediction and Adjuvant Treatment Based on CTC and ctDNA in NSCLC

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJiangsu Cancer Institute & Hospital

About this trial

This is a prospective cohort study, which aims to evaluate the effectiveness and superiority of a novel minimal residual disease-guided prognosis monitoring and adjuvant treatment in stage IIA-IIIC non-small cell lung cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Written informed consent must be signed before implementing any enrollment-related procedures;

Age ≥18 years old;

Patients with histologically or cytologically confirmed stage IIA-IIIC NSCLC (International Association for the Study of Lung Cancer and American Joint Committee on Classification of Cancer, 8th Edition TNM staging);

There is no special restriction on the source of genetic test report.

Disqualifiers

Received surgical treatment for lung tumors.

Received neoadjuvant chemotherapy or radiotherapy.

Received cellular therapy within the last 1 year.

Treated but uncontrolled diabetes, mellitus, asthma, autoimmune diseases and other chronic diseases.

Trial population

A total of 60 patients with histologically or cytologically confirmed stage IIA-IIIC NSCLC would be enrolled from Jiangsu Cancer Institute \& Hospital. In resectable group, we would enroll 20 early-stage cases and 20 operable patients for neoadjuvant treatment . In non-resectable group, 20 advanced-stage inoperable patients would be enrolled.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Operable

    Procedure/Surgery

    Enrolled patients capable of surgical treatment

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Operable group1 intervention
Group B: Inoperable group0 interventions

Trial outcomes

Primary outcomes

1

To evaluate the Progression-free Survival (PFS)

Progression-free survival (PFS) is defined as the time from the start of treatment to the occurrence of tumor progression or death due to any cause based on RECIST 1.1 assessed by investigator review.

Time frame
From the first study dose date to the date of first documentation of disease progression or death (whichever occurred first), up to approximately 3 years

Secondary outcomes

1

To evaluate the Overall Survival (OS)

Overall Survival (OS) was measured from the date of first dose of study drug until date of death from any cause. Participants who were lost to follow-up and the participants who were alive at the date of data cutoff was censored at the date the participant was last known alive, whichever came earlier.

Time frame
From the date of first dose of study drug until date of death from any cause (up to approximately 5 years )

Other outcomes

Sponsors and contacts

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