Nivolumab with chemotherapy for treating primary tracheal squamous cell carcinoma

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

This study is testing whether combining a new immune therapy called Nivolumab with chemotherapy can help people with a rare type of throat cancer before surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: The First Affiliated Hospital of Guangzhou Medical University (Academic / other)
• Drugs / interventions: Nivolumab, chemotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT05964101 on ClinicalTrials.gov

What this trial studies

This phase 2 clinical trial evaluates the safety and efficacy of combining Nivolumab with carboplatin and paclitaxel in 25 patients newly diagnosed with primary tracheal squamous cell carcinoma. The study aims to assess the impact of neoadjuvant immunochemotherapy on treatment outcomes, particularly in terms of surgical feasibility and pathological results. Given the rarity of primary tracheal tumors and the limited treatment options available, this research seeks to provide insights into effective therapeutic strategies for this challenging condition.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with confirmed tracheal squamous cell carcinoma and no evidence of metastasis.

Not a fit: Patients with metastatic disease or those with significant comorbidities affecting major organ function may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve treatment outcomes and surgical options for patients with primary tracheal squamous cell carcinoma.

How similar studies have performed: While neoadjuvant therapy has shown promise in other cancers, the specific application to primary tracheal squamous cell carcinoma is less explored, making this a novel investigation.

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.

Where this trial is running

Guangzhou, Guangdong

• The First Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Shuben Li, PhD

Conditions Neoplasms; Carcinoma, Squamous; Antineoplastic Agents; tracheal tumor; neoadjuvant immunochemotherapy; surgery