Clinical trial NCT04716751: Toripalimab Combined With Chemotherapy in Primary Tracheal Squamous Cell Carcinoma
Official title: Clinical Study of Neoadjuvant Anti-PD-1 Drug Toripalimab Combined With Chemotherapy in the Treatment of Primary Tracheal Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Tracheal Squamous Cell Carcinoma
Lead sponsor: Shanghai Pulmonary Hospital, Shanghai, China
Sponsor class: OTHER
First posted: 2021-01-20
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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;
* Complicated with HIV infection or active hepatitis.
* Vaccination within 4 weeks before the start of this trial;
* Those who had undergone other major operations or severe injuries within the previous 2 months;
* Clinically uncontrolled pleural effusion or ascites requiring pleural or abdominal puncture drainage within 2 weeks before admission;
* Pregnant or lactating women;
* Those with neurological diseases or mental disorders.
* Participated in another therapeutic clinical study at the same time;
* Other researchers did not consider it appropriate to enroll in the group.

Primary outcomes:
measure: Safety: frequency of severe adverse events
timeFrame: up to 5 months
measure: Major pathologic response (MPR)
timeFrame: up to 4 months
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: up to 60 months
measure: Progression-free survival (PFS)
timeFrame: up to 60 months
measure: Duration of remission (DOR)
timeFrame: up to 60 months
measure: Disease control rate (DCR)
timeFrame: up to 60 months
measure: Health related quality of life (HRQol)
timeFrame: up to 6 months
Other outcomes:
Locations:
Study officials:
References: