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

Launched by THE FIRST AFFILIATED HOSPITAL OF GUANGZHOU MEDICAL UNIVERSITY · Jul 19, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a combination of three treatments—Nivolumab, carboplatin, and paclitaxel—to see how safe and effective they are for patients with primary tracheal squamous cell carcinoma, a type of cancer that affects the trachea (the windpipe). The trial is currently looking for 25 patients who have recently been diagnosed with this cancer. To qualify, participants must be at least 18 years old and have a confirmed diagnosis through a biopsy, with no spread of the cancer to other parts of the body. They should also be in good overall health and able to undergo surgery if necessary.

If you or a loved one is considering participating in this trial, you can expect to receive these treatments and be closely monitored for any side effects or improvements in your condition. It’s important to note that certain health conditions and recent treatments could make someone ineligible for the study, so a careful screening process will be conducted. Participants will also need to provide informed consent, meaning they understand the trial and agree to take part. This trial represents an important step in exploring new treatment options for a challenging type of cancer.

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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.