Nivolumab Combined With Chemotherapy in the Treatment of Primary Tracheal Squamous Cell Carcinoma

Trial Title: Nivolumab Combined With Chemotherapy in the Treatment of Primary Tracheal Squamous Cell Carcinoma

NCT ID: NCT05964101

Condition: Neoplasms
Carcinoma, Squamous
Antineoplastic Agents

Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Paclitaxel
Carboplatin
Nivolumab

Conditions: Keywords:
tracheal tumor
neoadjuvant immunochemotherapy
surgery

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Nivolumab Injection [Opdivo]
Description: Neoadjuvant treatment stage: Nivolumab +Carboplatin AUC+ paclitaxel
Arm group label: Nivolumab

Other name: carboplatin

Other name: paclitaxel

Summary: 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.

Detailed description: 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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Bronchoscopic biopsy confirmed as tracheal squamous cell carcinoma by pathological examination 2. PET-CT confirmed no metastasis; 3. ECOG physical status score 0-1; 4. Bronchoscopy, and chest CT is evaluated as early or locally advanced tracheal malignant tumor, and radical surgery is expected to be feasible or after neoadjuvant therapy. 5. Age ≥ 18 years; 6. Have one measurable lesion at least; 7. 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 8. Fertile female patients must voluntarily take effective contraceptive measures more than 120 days after chemotherapy or the last administration of Nivolumab, 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 Nivolumab, whichever is the latter. 9. Sign informed consent; Exclusion Criteria: 1. Any Chinese herbal medicine used to control cancer was used within 14 days before the first administration of the study drug; 2. Patients with other malignant tumors in the five years before the start of this trial. 3. 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; 4. Active, known or suspected autoimmune diseases, or autoimmune paraneoplastic syndrome requiring systemic treatment; 5. 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.); 6. Had is suffering from nephrotic syndrome 7. Allergic to experimental drugs; 8. Complicated with HIV infection or active hepatitis. 9. Vaccination within 4 weeks before the start of this trial; 10. Those who had undergone other major operations or severe injuries within the previous 2 months; 11. Clinically uncontrolled pleural effusion or ascites requiring pleural or abdominal puncture drainage within 2 weeks before admission; 12. Pregnant or lactating women; 13. Those with neurological diseases or mental disorders. 14. Participated in another therapeutic clinical study at the same time; 15. Other researchers did not consider it appropriate to enroll in the group.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: The First Affiliated Hospital of Guangzhou Medical University

Address:
City: Guangzhou
Zip: 510120
Country: China

Status: Recruiting

Contact:
Last name: Shuben Li, Doctor
Email: 13500030280@163.com

Start date: October 1, 2023

Completion date: May 31, 2026

Lead sponsor:
Agency: The First Affiliated Hospital of Guangzhou Medical University
Agency class: Other

Source: The First Affiliated Hospital of Guangzhou Medical University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05964101