Actively Recruiting
Nivolumab Combined With Chemotherapy in the Treatment of Primary Tracheal Squamous Cell Carcinoma
Led by The First Affiliated Hospital of Guangzhou Medical University · Updated on 2024-05-21
25
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Nivolumab Combined With Chemotherapy in the Treatment of Primary Tracheal Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Bronchoscopic biopsy confirmed as tracheal squamous cell carcinoma by pathological examination
- PET-CT confirmed no metastasis
- ECOG physical status score 0-1
- Bronchoscopy and chest CT evaluated as early or locally advanced tracheal malignant tumor with expected feasibility of radical surgery or after neoadjuvant therapy
- Age 18 years or older
- Presence of at least one measurable lesion
- Good function of major organs: ANC 1.5 10^9/L, platelet 100 10^9/L, hemoglobin 90g/L; no blood transfusion or growth factor support within 14 days before screening; INR or PT 1.5 times normal upper limit; APTT 1.5 times upper limit; serum total bilirubin 1.5 times upper limit (Gilbert syndrome patients under 3 times upper limit); for fertile females AST and ALT 2.5 times upper limit or 5 times with liver metastasis
- Fertile female patients must use effective contraception for more than 120 days after chemotherapy or last Nivolumab dose and have negative pregnancy test within 7 days before enrollment
- Unsterilized male patients must use effective contraception for at least 120 days after chemotherapy or last Nivolumab dose
- Signed informed consent
You will not qualify if you...
- Use of Chinese herbal medicine for cancer control within 14 days before first study drug administration
- Other malignant tumors within five years prior to trial start
- Unstable systemic diseases including active infections, uncontrolled hypertension, unstable angina, congestive heart failure above class II, severe arrhythmias, liver, kidney, or metabolic diseases
- Active or suspected autoimmune diseases requiring systemic treatment
- History of active bleeding or embolism within six months or recent thrombolysis or anticoagulation therapy
- Nephrotic syndrome
- Allergies to study drugs
- HIV infection or active hepatitis
- Vaccination within four weeks before trial start
- Major surgery or severe injury within two months prior
- Clinically uncontrolled pleural effusion or ascites requiring drainage within two weeks before admission
- Pregnant or lactating women
- Neurological diseases or mental disorders
- Participation in another therapeutic clinical study simultaneously
- Other conditions deemed inappropriate by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510120
Actively Recruiting
Research Team
S
Shuben Li, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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