Clinical Study of Neoadjuvant Anti-PD-1 Drug Toripalimab Combined With Chemotherapy in the Treatment of Primary Tracheal Squamous Cell Carcinoma

Shanghai Pulmonary Hospital, Shanghai, China0 sites15 target enrollmentFebruary 1, 2021

ConditionsTracheal Squamous Cell Carcinoma

InterventionsToripalimab

DrugsToripalimab

Overview

Phase: Phase 2
Intervention: Toripalimab
Conditions: Tracheal Squamous Cell Carcinoma
Sponsor: Shanghai Pulmonary Hospital, Shanghai, China
Enrollment: 15
Primary Endpoint: Safety: frequency of severe adverse events
Status: Not yet recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This is a single-arm, open, II phase study to evaluate the safety and efficacy of Toripalimab + carboplatin + paclitaxel in 15 newly diagnosed patients with tracheal malignant tumors.

Registry

clinicaltrials.gov

Start Date

February 1, 2021

End Date

May 31, 2025

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Responsible Party

Principal Investigator

Peng Zhang

Director of thoracic department

Shanghai Pulmonary Hospital, Shanghai, China

Eligibility Criteria

Inclusion Criteria

•Bronchoscopic biopsy confirmed as tracheal malignant tumor by pathological examination
•PET-CT confirmed no metastasis;
•ECOG physical status score 0-1;
•Bronchoscopy, chest CT is evaluated as early or locally advanced tracheal malignant tumor, and radical surgery is expected to be feasible or after neoadjuvant therapy.
•Age ≥ 18 years;
•Have one measurable lesions at least;
•Good function of other major organs (liver, kidney, blood system, etc.):-absolute neutrophil count ((ANC) ≥ 1.5 × 109), platelet (≥ 100 × 109), hemoglobin (≥ 90g/L). Note: patients shall not receive blood transfusion or growth factor support within 14 days before blood collection during the screening period;-International standardized ratio (INR) or prothrombin time (PT) ≤ 1.5 × normal upper limit (ULN);-activated partial thromboplastin time (APTT) ≤ 1.5 × ULN;- serum total bilirubin ≤ 1.5 × ULN (Gilbert syndrome patients with total bilirubin must be \< 3×ULN). Fertile female patients with aspartate and alanine aminotransferase (AST and ALT) ≤ 2.5 × ULN, or liver metastasis with AST and ALT ≤ 5 × ULN
•Fertile female patients must voluntarily take effective contraceptive measures more than 120 days after chemotherapy or the last administration of triplizumab, whichever is later, and the urine or serum pregnancy test results less than 7 days before entering the group were negative. Unsterilized male patients must voluntarily take effective contraceptive measures ≥ 120 days after chemotherapy or the last administration of triplizumab, whichever is the later.
•Sign informed consent;

Exclusion Criteria

•Systemic anticancer therapy for tracheal malignant tumors, including surgery, radiotherapy, chemotherapy, targeted therapy and experimental therapy.
•Any Chinese herbal medicine used to control cancer was used within 14 days before the first administration of the study drug;
•Patients with other malignant tumors in the five years before the start of this trial.
•Complicated with unstable systemic diseases, including active infections, uncontrolled hypertension, unstable angina pectoris, congestive heart failure \[higher than II (New York College of Cardiology)\], severe arrhythmias, liver, kidney or metabolic diseases;
•Active, known or suspected autoimmune diseases, or autoimmune paraneoplastic syndrome requiring systemic treatment;
•The infection was treated with antibiotics within 4 weeks before the start of the trial;
•A history of active bleeding or embolism within 6 months, or received thrombolysis or anticoagulation therapy, or the researchers believe that there is an obvious tendency of gastrointestinal bleeding (such as esophageal varices have the risk of bleeding, local active ulcer lesions, etc.);
•Had or is suffering from nephrotic syndrome
•Has been or is suffering from chronic obstructive pneumonia, bronchiectasis, or interstitial lung disease;
•Allergic to experimental drugs;

Arms & Interventions

Toripalimab

Intervention: Toripalimab

Outcomes

Primary Outcomes

Safety: frequency of severe adverse events

Time Frame: up to 5 months

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.

Major pathologic response (MPR)

Time Frame: up to 4 months

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.