Actively Recruiting
Neoadjuvant Personalized Anti-PD-1 and Anti-VEGFR Therapy in OSCC Patients
Led by Shanghai Jiao Tong University School of Medicine · Updated on 2023-11-22
46
Participants Needed
1
Research Sites
356 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the efficacy of neoadjuvant anti-PD-1 plus anti-VEGFR therapy for patients with locally advanced and resectable oral squamous cell carcinoma, and the CPS\>10 in the biopsy samples.
CONDITIONS
Official Title
Neoadjuvant Personalized Anti-PD-1 and Anti-VEGFR Therapy in OSCC Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Male or female gender
- ECOG performance status score of 0 to 2
- Histologically confirmed primary oral squamous cell carcinoma (including tongue, gingival, buccal, oral base, hard palate, posterior molar area)
- Clinical stage III or IVA (cT1-2/N1-2/M0 or cT3-4a/N0-2/M0, AJCC 8th edition)
- Combined positive score (CPS) for PD-L1 expression greater than 10
- Signed informed consent
You will not qualify if you...
- Grade 2 or higher toxicity from previous anticancer therapy that has not resolved (per CTCAE 5.0)
- Significant cardiovascular conditions such as myocardial infarction or severe heart disease diagnosed within 3 months before enrollment
- Active severe infections graded above level 2 (NCI-CTCAE Version 5.0)
- Uncontrolled hypertension (systolic >150 mmHg or diastolic >90 mmHg despite medication) or serious cardiovascular diseases including recent cerebrovascular accident or unstable angina
- Abnormal blood counts: white blood cells less than 3000/mm3, hemoglobin less than 8 g/L, or platelets less than 80,000/mm3
- Impaired liver function with ALAT/ASAT over 2.5 times or bilirubin over 1.5 times the normal upper limit
- Impaired kidney function with serum creatinine over 1.5 times the normal upper limit
- History of maxillofacial and neck radiotherapy
- Pregnant or breastfeeding women
- Participation in other clinical trials within 30 days before enrollment
- Any other condition the investigator deems unsuitable for participation
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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