Actively Recruiting
Neoadjuvant Anti-PD-1 and TP Versus TPF on Pathological Response in OSCC
Led by Shanghai Jiao Tong University School of Medicine · Updated on 2023-11-22
80
Participants Needed
1
Research Sites
273 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To compare the pathological efficacy of neoadjuvant Toripalimab and Albumin paclitaxel /Cisplatin (TTP) with Docetaxel/ Cisplatin/ 5-flurouracil (TPF) for patients with locally advanced resectable oral squamous cell carcinoma (OSCC), and to determine the safety of neoadjuvant TTP. In order to explore a better protocol of neoadjuvant therapy to improve the efficacy in patients with locally advanced OSCC.
CONDITIONS
Official Title
Neoadjuvant Anti-PD-1 and TP Versus TPF on Pathological Response in OSCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years old
- Male or female gender
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Histologically confirmed diagnosis of oral squamous cell carcinoma in specific oral regions
- Clinical stage III or IVA tumor according to AJCC 2018 criteria
- At least one measurable tumor lesion per RECIST v1.1 criteria
- White blood cell count above 3,000/mm3, hemoglobin above 8 g/L, and platelet count above 80,000/mm3
- Liver enzymes (ALAT/ASAT) less than 2.5 times upper limit of normal and bilirubin less than 1.5 times upper limit
- Serum creatinine less than 1.5 times upper limit of normal
- Coagulation parameters (INR, PT, APTT) less than 1.5 times 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 allergy to any components of the treatments
- History of other cancers unless cured with no recurrence for 5 years
- Previous radiation therapy to head and neck
- Active severe infection above grade 2 by NCI-CTCAE 5.0
- Significant cardiovascular disease within 3 months before enrollment
- Current immunology-based treatments
- History of active bleeding, coagulopathy, or on coumarin anticoagulants
- Pregnancy or lactation
- Uncontrolled high blood pressure or clinically significant cardiovascular disease
- Severe uncontrolled infection or HIV/AIDS
- Uncontrolled autoimmune disease or history of transplantation
- Participation in another clinical trial within 30 days
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 20011
Actively Recruiting
Research Team
L
Lai-ping Zhong, MD, PhD
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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