Toripalimab Combined With Chemotherapy in Primary Tracheal Squamous Cell Carcinoma

NCT04716751 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2021-01-26

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04716751 on ClinicalTrials.gov