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

Sponsor
The First Affiliated Hospital of Guangzhou Medical University
Study ID
NCT05964101
Phase
PHASE2
Status
Unknown

Conditions

  • Antineoplastic Agents
  • Carcinoma, Squamous
  • Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Oct 1, 2023
Status verified
May 2024
Primary completion
Aug 1, 2025
Completion
May 31, 2026

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab
    Neoadjuvant treatment stage: Nivolumab 360mg, Carboplatin AUC5+ paclitaxel 100 mg/m ², iv, 3 weeks per cycle, 2-4 cycles in total; Surgical treatment stage: Patients with primary tracheal squamous cell carcinoma received radical surgery after neoadjuvant therapy, and patients who could not or refused surgical treatment due to various reasons were treated with multidisciplinary discussion.

Primary Outcome Measure

Major pathologic response (MPR) [ Time Frame: up to 4 months ]

Central Contacts

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