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Recruiting Phase 2

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

NCT05964101 · tracked via the Priya Life Science China tracker
Phase
Phase 2
Started
2023-08-15
Last updated
2026-11-09

Condition(s) studied

NeoplasmsCarcinoma, SquamousAntineoplastic Agents

Investigational drug(s) / intervention(s)

Nivolumab Injection [Opdivo] →

Nivolumab Injection [Opdivo]: Neoadjuvant treatment stage: Nivolumab +Carboplatin AUC+ paclitaxel

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Safety: frequency of severe adverse events — 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.
  • R0 rate — up to 4 months
    There were no visible tumors in the surgical margin, and the tumor cells in the surgical margin within 1mm were negative under the microscope

Trial sites (1)

FacilityCityRegionStatus
The First Affiliated Hospital of Guangzhou Medical University Guangzhou Guangdong Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05964101 on ClinicalTrials.gov ↗ ← All trials in China