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New treatment option for Locally Advanced Head and Neck Squamous Cell Carcinoma
Official title Tirilizumab with Albumin-bound Paclitaxel and Cisplatin for Locally Advanced Resectable Oral Squamous Cell Carcinoma
ClinicalTrials.gov ID: NCT06470217
What this study is testing
What is tirilizumab with albumin-bound paclitaxel and cisplatin?
tirilizumab with albumin-bound paclitaxel and cisplatin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for locally advanced head and neck squamous cell carcinoma.
Also referred to as neoadjuvant arm.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The dosing regimen in the trial group was: tirilizumab with albumin-bound paclitaxel and cisplatin for 3 preoperative Cycles. After neoadjuvant therapy, patients underwent surgery and were stratified according to pathological conditions after surgery; if significant pathological remission (MPR) was achieved, 6 cycles of adjuvant therapy with tirilizumab monotherapy (concurrent radiochemotherapy was available for those with high-risk factors) were performed; if MPR was not achieved, concurrent radiochemotherapy was performed.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Age 18-75 years, male or female; Patients with primary stage III-IVa surgically resectable squamous cell carcinoma of the oral cavity with measurable...
- Reproductively active female people must have a negative serum pregnancy test prior to the first dose of the test drug.
- Reproductively active male or female people must be using a highly effective method of contraception (e.g., oral contraceptive pill, intrauterine...
You likely can't join if
- With distant metastatic lesions or localised lesions without indication for surgery (stage IVb or IVc patients); Prior history of a primary tumour of...
- If HCV antibody test result is positive, add HCV RNA (result above upper limit of normal range); Known hypersensitivity to recombinant humanised PD-1...
- The following within 6 months prior to first dose: deep vein thrombosis or pulmonary embolism; myocardial infarction; severe or unstable arrhythmia...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.