A Clinical Study on the Intranasally-administered Recombinant Adenovirus Vaccine for the Treatment of Advanced HPV-Positive Oropharyngeal Squamous Cell Carcinoma
- Conditions
- Advanced HPV-Positive Oropharyngeal Squamous Cell Carcinoma
- Registration Number
- ChiCTR2400084773
- Lead Sponsor
- West China Hospital of Sichuan University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
<br>1. Patients with with histologically or cytologically documented recurrent or metastatic oropharyngeal squamous cell carcinoma, who are no longer eligible for local curative treatments such as surgery or radiotherapy, and who have experienced disease progression or intolerance to adverse effects during or after prior second-line or higher systemic therapy;<br>2. Diffuse expression of HPV16 E6/E7 protein in the tumor as analyzed by immunohistochemistry on paraffin embedded tumor tissue;<br>3. HPV 16 positivity as tested by HPV genotyping from tumor tissue;<br>4. Males or females aged >=18 years; expected survival of at least 6 months; ECOG performance status of 0, 1, or 2;<br>5. More than 4 weeks have elapsed since the end of prior treatment, and the patient has fully recovered from the adverse effects of prior treatment;<br>6. Laboratory tests:<br>ANC >= 1.5 × 10^9/L, TLC >= 0.4 × 10^9/L, PLT >= 100 × 10^9/L, Hb >= 9.0 g/dL; BUN and Cr within normal range; TBIL <= 1.5 times the upper limit of normal (ULN); AST and ALT <= 1.5 times ULN; Ad5 neutralizing antibody titer <= 1:200;<br>7. Patient´s written informed consent for participation in the trial.
<br>1. Patients with severe internal medical conditions, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, severe infection, active peptic ulcer disease, active bleeding, etc.;<br>2. Patients with immunodeficiency diseases, autoimmune diseases, or infectious diseases that are difficult to control;<br>3. Patients with uncontrolled primary or metastatic brain tumors;<br>4. Patients with mental or addiction disorders that could impair informed consent ability;<br>5. Pregnant or lactating women;<br>6. Fertile patients who cannot take effective contraceptive measures.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of adverse events (type, frequency, severity);Blood test (antigen-specific immune responses, inflammatory factors, complete blood count, and biochemical analysis indicators);
- Secondary Outcome Measures
Name Time Method Objective Response Rate;Overall survival;Complete response;Partial response;Stable disease;Progressive disease;Disease control rate;Tumor microenvironment;