This is a single-arm, open, II phase study to evaluate the safety and efficacy of Nivolumab + carboplatin + paclitaxel in 25 newly diagnosed patients with primary tracheal squamous cell carcinoma.
Primary tracheal tumors are rare, comprising 0.01-0.4% of all cancer cases. Most airway tumors present with non-specific symptoms, such as shortness of breath and a sore throat, which may not be attributable to the tumors themselves, leading to diagnostic delay. With limited treatment options, surgical resection is considered the cornerstone therapy. Neoadjuvant therapy is recommended as standard treatment for the early stages (stage IB/II) and locally advanced stages (stage IIIA) of non-small cell lung cancer (NSCLC). Whether neoadjuvant therapy affects subsequent pathological or surgical outcomes of primary tracheal tumors remains unclear. This study aimed to characterize the outcomes of neoadjuvant therapy for the treatment of primary tracheal squamous cell carcinoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Neoadjuvant treatment stage: Nivolumab +Carboplatin AUC+ paclitaxel
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
RECRUITINGMajor pathologic response (MPR)
MPR is defined as the proportion of participants who have achieved major pathologic response (on routine hematoxylin and eosin staining, tumors with no more than 10% viable tumor cells) in all participants who have completed the neoadjuvant therapy before surgery
Time frame: up to 4 months
Safety: frequency of severe adverse events
The frequency of severe adverse events from the participants enrolling to 30 days after the last drug administration or 30 days after surgery or new anti-cancer therapy, which comes first.
Time frame: up to 5 months
Progression-free survival (PFS)
PFS is defined as the time from the enrollment of the subject to the first determination of disease progression or death of any cause according to RECISTv1.1, whichever occurs first.
Time frame: up to 24 months
Overall survival (OS)
It is defined as the time from enrollment to death of participant due to any cause. In the case of a patient who still survives at the time of analysis, the date of last contact will be taken as the censoring date. In the event of a patient with the survival status unknown, the date when the patient is last known to be alive will be used for interpolation (censoring).
Time frame: up to 60 months
Disease control rate (DCR)
The proportion of patients whose best overall remission (BOR) is CR, PR or disease stable (SD) according to RECISTv1.1 evaluation
Time frame: up to 60 months
Duration of remission (DOR)
According to the time from the first recording of objective remission to relapse or death from any cause determined by RECISTv1.1, whichever occurs first.
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Time frame: up to 60 months
R0 rate
There were no visible tumors in the surgical margin, and the tumor cells in the surgical margin within 1mm were negative under the microscope
Time frame: up to 4 months