Actively Recruiting
Neoadjuvant Immunochemotherapy for LAOSCC
Led by Lai-ping Zhong · Updated on 2025-03-13
134
Participants Needed
1
Research Sites
253 weeks
Total Duration
On this page
Sponsors
L
Lai-ping Zhong
Lead Sponsor
S
Sun Yat-sen University
Collaborating Sponsor
AI-Summary
What this Trial Is About
To evaluate the prognostic efficacy of neoadjuvant immunochemotherapy with tislelizumab, albumin paclitaxel and cisplatin followed by radical surgery and adjuvant therapy compared with standard therapy for patients with locally advanced and resectable oral squamous cell carcinoma.
CONDITIONS
Official Title
Neoadjuvant Immunochemotherapy for LAOSCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Histopathological diagnosis of oral squamous cell carcinoma including tongue, gums, cheek, floor of mouth, hard palate, or posterior molar region
- Clinical stage III or IVA tumor (T1-2/N1-2/M0 or T3-4a/cN0-2/M0, AJCC 2018)
- At least one measurable lesion according to RECIST version 1.1
- White blood cell count greater than 3,000/mm3
- Hemoglobin level greater than 8 g/L
- Platelet count greater than 80,000/mm3
- Liver enzymes (ALAT/ASAT) less than 2.5 times the upper limit of normal
- Bilirubin less than 1.5 times the upper limit of normal
- Serum creatinine less than 1.5 times the upper limit of normal
- Coagulation tests (INR, PT, APTT) less than 1.5 times the upper limit of normal
- Signed informed consent form
You will not qualify if you...
- Unresolved grade 2 or higher toxic reactions from previous anticancer treatments
- Known severe allergic reactions (grade 3-4) to any ingredients of the study therapy
- History of other malignancies unless cured with no recurrence for 5 years
- Previous radiation therapy to the head and neck
- Active severe infections above grade 2 severity
- Significant cardiovascular abnormalities such as recent myocardial infarction or grade 2 or higher heart disease
- Current immunology-based treatments
- History of active bleeding, coagulopathy, or use of coumarin anticoagulants
- Pregnancy or lactation
- Active hepatitis B or C infection or serious liver diseases
- Severe uncontrolled infections, HIV/AIDS, uncontrolled autoimmune disease, or history of organ or stem cell transplantation
- Participation in another clinical trial within 30 days prior to enrollment
- Any other condition judged by the investigator to be unsuitable for participation in the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Huashan Hospital, Fudan University
Shanghai, China, 200040
Actively Recruiting
Research Team
L
Lai-ping Zhong, MD, PhD
CONTACT
Y
Ying-ying Huang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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