Actively Recruiting
Tirelizumab in Combination With Carboplatin and Albumin-binding Paclitaxel for Neoadjuvant Therapy in HNSCC
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2023-07-12
100
Participants Needed
1
Research Sites
365 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
In this study, 100 patients with resectable head and neck squamous cell carcinoma (oral squamous cell carcinoma and oropharyngeal squamous cell carcinoma) were enrolled, who were combined with tirelizumab, carboplatin and albumin-binding paclitaxel before and after surgery. Tumor tissues and paracancer tissues of patients were collected to observe the imaging and pathological changes before and after treatment. At the same time, clinical information of patients, such as pathological grade, stage, treatment, prognosis, serology, imaging, etc. were collected to evaluate the safety and feasibility of tirelizumab combined with carboplatin and albumin-binding paclitaxel for neoadjuvant therapy of resectable oral and oropharyngeal squamous cell carcinoma. This is a prospective, one-arm, phase II clinical study. Purpose Main purpose The efficacy of Tirelizumab combined with carboplatin and albumin-paclitaxel in neoadjuvant therapy for resectable head and neck squamous cell carcinoma was evaluated by calculating the major pathological response (MPR) rates in the experimental group. The severity of adverse events associated with neoadjuvant therapy will be graded according to NCI CTCAE (version 5.0) during the course of this study and during follow-up, the incidence of adverse events in the experimental and control groups will be compared, and the safety of neoadjuvant therapy with Tirelizumab combined with carboplatin and albumin-paclitaxel in resectable head and neck squamous cell carcinoma will be evaluated. Secondary Purpose 1. One-year event survival rate and event-free survival (EFS) of enrolled patients were evaluated (five years); 2. Pathological complete response rate (pCR) of enrolled patients was evaluated (5 years); 3. pTR of enrolled patients was evaluated; 4. Overall survival (OS) of enrolled patients was evaluated (5 years); 5. Radiological response of enrolled patients was assessed; 6. The rate of operation delay of enrolled patients was evaluated;
CONDITIONS
Official Title
Tirelizumab in Combination With Carboplatin and Albumin-binding Paclitaxel for Neoadjuvant Therapy in HNSCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years
- Cytological or histological diagnosis of surgically resectable squamous cell carcinoma of the head and neck at stages T3-4a, N0-2, M0
- At least one measurable lesion by RECIST 1.1 criteria
- No prior systemic antitumor therapy for advanced/metastatic disease; prior platinum-containing adjuvant/neoadjuvant chemotherapy or radical chemoradiotherapy allowed if at least 6 months since last treatment
- ECOG performance status of 0 or 1
- Expected survival time greater than 3 months
- Adequate organ function meeting specified laboratory parameters
- Negative pregnancy test within 3 days before first study drug administration for women of childbearing potential
- Use of effective contraception during treatment and up to 120 days after last study drug administration
You will not qualify if you...
- Malignant diseases other than head and neck squamous cell carcinoma diagnosed within 5 years prior to study start (except certain treated skin cancers)
- Participation in other interventional clinical studies or use of investigational drugs/devices within 4 weeks before dosing
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or other T cell receptor-targeting drugs
- Recent systemic treatment with Chinese patent or immunomodulatory drugs for head and neck cancer within 2 weeks before first administration
- Active autoimmune disease requiring systemic treatment within 2 years prior to study
- Systemic glucocorticoid or immunosuppressive therapy within 7 days before dosing, except low-dose glucocorticoids
- Clinically uncontrollable pleural or abdominal effusion
- Known allogeneic organ or stem cell transplantation (except corneal transplant)
- Allergy to study drugs or excipients
- Not fully recovered from prior treatment toxicities above grade 1
- Known HIV infection
- Untreated active hepatitis B or active hepatitis C infection
- Receipt of live vaccine within 30 days before dosing
- Pregnant or lactating women
- Serious or uncontrolled systemic diseases including significant heart abnormalities, unstable angina, recent thrombosis, poor blood pressure control, active lung or liver diseases, poorly controlled diabetes, significant proteinuria, mental disorders preventing cooperation, or other conditions deemed unsuitable by investigators
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Trial Site Locations
Total: 1 location
1
Sun yat-sun memorial hospital
Guangzhou, Guangdong, China, 510000
Actively Recruiting
Research Team
H
Haotian Cao, MD
CONTACT
J
Jinsong Li
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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