Actively Recruiting
Neoadjuvant Anti-PD-1 Immunotherapy With Chemotherapy in Resectable Locally Advanced Oral Squamous Cell Carcinoma
Led by Hospital of Stomatology, Wuhan University · Updated on 2024-04-02
309
Participants Needed
3
Research Sites
149 weeks
Total Duration
On this page
Sponsors
H
Hospital of Stomatology, Wuhan University
Lead Sponsor
J
Jiangsu HengRui Medicine Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to investigate the survival benefit of neoadjuvant anti-PD-1 immunotherapy plus TP chemotherapy compared with TP chemotherapy or up-front surgery in resectable locally advanced oral squamous cell carcinoma.
CONDITIONS
Official Title
Neoadjuvant Anti-PD-1 Immunotherapy With Chemotherapy in Resectable Locally Advanced Oral Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed oral squamous cell carcinoma by biopsy.
- Locally advanced oral squamous cell carcinoma (clinical stage T1-2N1-2M0, T3-4aN0-2M0) with a surgical option for potential cure, as assessed by a surgeon.
- No distant metastasis confirmed by chest CT and emission computed tomography.
- Adequate organ function including leukocyte count ≥ 2,000/mm3, absolute neutrophil count ≥ 1,000/mm3, platelet count ≥ 100,000/mm3, hemoglobin ≥ 90 g/L, serum albumin ≥ 30 g/L, total bilirubin ≤ 1.5 × upper limit of normal (ULN), AST and ALT < 2.5 × ULN, ALP ≤ 2.5 × ULN, prothrombin time-INR ≤ 1.5, serum creatinine ≤ 1.5 × ULN, INR/PT ≤ 1.5, and TSH ≤ ULN.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Female patients must test negative for HCG in serum or urine within 7 days before starting treatment and agree to use contraception along with their partner during the study and for up to 120 days after the last dose of PD-1 blockade.
- Ability and willingness to understand the study, its requirements, risks, and to sign informed consent.
You will not qualify if you...
- History of grade 3 or higher immune-related adverse events or unresolved grade 2 or lower immune-related adverse events from prior treatments.
- Treatment for cancer including surgery, chemotherapy, radiotherapy, or targeted therapy within the past 5 years.
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or other antibodies targeting T cell pathways.
- Active or refractory autoimmune diseases.
- Active systemic infections needing treatment.
- Current use of psychotropic drugs or history of substance abuse.
- Concurrent active malignancies.
- HIV infection or untreated active hepatitis B or C infections, or recent vaccinations within 4 weeks before recruitment.
- Uncontrolled systemic diseases such as diabetes or hypertension.
- Stroke or transient ischemic attack within the past 6 months.
- Presence of distant metastases or tumors deemed unresectable.
- Serious cardiovascular, respiratory, immune system, or other critical diseases increasing risk as judged by researchers.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Peking university Shenzhen hospital
Shenzhen, Guangdong, China, 518036
Not Yet Recruiting
2
Hospital of Stomatology, Wuhan University
Wuhan, Hubei, China, 430079
Actively Recruiting
3
Xiangya Hospital of Central South University
Changsha, Hunan, China, 410008
Actively Recruiting
Research Team
G
Gang Chen, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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