Toripalimab Combined With Chemotherapy in Primary Tracheal Squamous Cell Carcinoma
NCT04716751 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2021-01-26
Summary
This is a single-arm, open, II phase study to evaluate the safety and efficacy of Toripalimab + carboplatin + paclitaxel in 15 newly diagnosed patients with tracheal malignant tumors.
Conditions
- Tracheal Squamous Cell Carcinoma
Interventions
- DRUG
-
Toripalimab
Neoadjuvant treatment stage: Toripalimab 240mg, Carboplatin AUC5+ paclitaxel 200 mg/m ², iv, 3 weeks per cycle, 2-4 cycles in total; Surgical treatment stage: Patients with tracheal malignant tumor received radical surgery after neoadjuvant therapy, and patients who could not or refused surgical treatment due to various reasons were treated with multidisciplinary discussion. Adjuvant treatment stage: Toripalimab 240mg, Carboplatin AUC5+ paclitaxel 200 mg/m ²,iv, up to 4 cycles (including neoadjuvant stage).
Sponsors & Collaborators
-
Shanghai Pulmonary Hospital, Shanghai, China
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-02-01
- Primary Completion
- 2022-01-31
- Completion
- 2025-05-31
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