Actively Recruiting
Neoadjuvant Anti-PD-1 Immunotherapy Plus TP Chemotherapy Versus TP Chemotherapy or Surgery in Resectable Locally Advanced Oral Squamous Cell Carcinoma: A Multi-Center Phase III Trial
Led by Hospital of Stomatology, Wuhan University · Updated on 2024-04-02
309
Participants Needed
3
Research Sites
13 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
Researchers are investigating the survival benefits of combining neoadjuvant anti-PD-1 immunotherapy with TP chemotherapy compared to TP chemotherapy alone or immediate surgery in patients with resectable locally advanced oral squamous cell carcinoma. This Phase III study aims to verify the effectiveness and safety of this combined treatment and explore immune cell changes in tumors, lymph nodes, and blood related to patient response and prognosis. Participants are divided into three groups: one receives radical surgery followed by radiotherapy or chemoradiotherapy as needed; another receives two cycles of TP chemotherapy before surgery and possible postoperative therapy; the third group receives three doses of anti-PD-1 immunotherapy plus two cycles of TP chemotherapy before surgery and subsequent radiotherapy or chemoradiotherapy if required. The chemotherapy drugs include docetaxel and cisplatin given by intravenous infusion, and the immunotherapy drug camrelizumab is also administered intravenously every two weeks. During the study, participants will undergo surgery and may receive additional radiotherapy or chemoradiotherapy. Researchers will assess event-free survival over 24 months as the primary outcome and monitor overall survival, radiographic and pathological responses, and adverse events throughout the study period. The trial involves detailed evaluations of immune responses and patient prognosis, with the total follow-up lasting up to two years after treatment.
CONDITIONS
Brief 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 stage (T1-2N1-2M0, T3-4aN0-2M0) with option for surgical removal.
- No distant metastasis confirmed by chest CT and emission computed tomography.
- Adequate organ function including leukocytes, neutrophils, platelets, hemoglobin, albumin, bilirubin, liver enzymes, coagulation, creatinine, and thyroid function within specified limits.
- ECOG performance status 0 or 1.
- Female participants must have negative pregnancy test within 7 days before treatment and agree to contraception during study and 120 days after last PD-1 dose.
- Ability and willingness to understand study requirements and provide informed consent.
You will not qualify if you...
- History of grade 3 or higher immune-related adverse events or unresolved grade 2 or higher adverse events.
- Prior cancer treatments including surgery, chemotherapy, radiotherapy, or targeted therapy within last 5 years.
- Previous treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or similar immune checkpoint antibodies.
- Active or refractory autoimmune diseases.
- Active systemic infections requiring treatment.
- Current use of psychotropic drugs or substance abuse.
- Other active malignancies.
- HIV infection or untreated active hepatitis B or C, or vaccination within 4 weeks before enrollment.
- Uncontrolled systemic diseases like diabetes or hypertension.
- Stroke or transient ischemic attack within past 6 months.
- Presence of distant metastases or unresectable tumor.
- Serious cardiovascular, respiratory, immune, or other critical diseases increasing risk as assessed by researchers.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 weeks
Participants receive neoadjuvant treatment with either anti-PD-1 immunotherapy plus TP chemotherapy, TP chemotherapy alone, or proceed directly to surgery.
3 infusion visits for PD-1 blockade and 2 chemotherapy cycles over 6 weeks
Duration - Up to 4 weeks or as clinically indicated
Participants undergo radical surgery to remove the tumor followed by radiotherapy or chemoradiotherapy if necessary.
1 surgery visit and approximately 6 post-operative visits
Duration - Up to 24 months
Participants are monitored for survival, adverse events, and disease progression after treatment completion.
Regular follow-up visits according to trial schedule
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.
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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