Phase 2: testing Nivolumab Injection [Opdivo] for Neoplasms
This is a single-arm, open, II phase study to measure the safety and how well it works of Nivolumab + carboplatin + paclitaxel in 25 newly diagnosed patients with primary tracheal squamous cell carcinoma.
Official registry: https://clinicaltrials.gov/study/NCT05964101 · The First Affiliated Hospital of Guangzhou Medical University · enrollment listed as 25
What this phase means
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Nivolumab Injection [Opdivo]. The registry lists allocation as na. This is a single-arm, open, II phase study to measure the safety and how well it works of Nivolumab + carboplatin + paclitaxel in 25 newly diagnosed patients with primary tracheal squamous cell carcinoma.
They plan to enroll about 25 people at Guangzhou. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
Neoadjuvant Anti-PD-1 Drug Nivolumab Combined With Chemotherapy in the Treatment of Primary Tracheal Squamous Cell Carcinoma
Interventions: Nivolumab Injection [Opdivo]
Primary outcome (registry wording): Safety: frequency of severe adverse events
Who it is for (from inclusion criteria)
- Ages 18 Years to 75 Years
- 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 is evaluated as early or locally advanced tracheal malignant tumor, and radical surgery is expected to be feasible or after neoadjuvant therapy
- Have one measurable lesion at least;
Who the registry excludes
- Any Chinese herbal medicine used to control cancer was used within 14 days before the first administration of the study drug;
- Patients with other malignant tumors in the five years before the start of this trial
- 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;
- Active, known or suspected autoimmune diseases, or autoimmune paraneoplastic syndrome requiring systemic treatment;
- Had is suffering from nephrotic syndrome
- Allergic to experimental drugs;
- Complicated with HIV infection or active hepatitis
Public study contact (from the registry)
Shuben Li, PhD
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
1 listed- The First Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (recruiting)
FAQ about this NCT record
Is NCT05964101 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT05964101?
Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT05964101?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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