Advanced HPV-Positive Oropharyngeal Squamous Cell Carcinoma
Conditions
Interventions
Part A-Low-dose group:200 µl (4 x 10^10 vp) intranasally-administered recombinant adenovirus vaccine, 100 µl into each nostril using nasal spray
Part A-Middle-dose group:200 µl (8 x 10^10 vp) intranasally-administered recombinant adenovirus vaccine, 100 µl into each nostril using nasal spray
Part A-High-dose group:200 µl (1.6 x 10^11 vp) intranasally-administered recombinant adenovirus vaccine, 100 µl into each nostril using nasal spray
Part B – Combination Treatment:After the recommended dose (RD) has been determined in Part A, three newly enrolled participants will receive the intranasal vaccine at the RD in combination with tislel
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Eligibility Criteria for Part A 1. Histologically or cytologically confirmed locally advanced, recurrent, or metastatic oropharyngeal squamous cell carcinoma that is not amenable to, or for which the patient has declined, definitive local treatment such as surgery or radiotherapy; or status post surgical resection with no definitive evidence of residual disease and satisfactory postoperative recovery, but with a high risk of recurrence, and willing to receive immunotherapy for the prevention of recurrence; 2. Confirmed HPV16-positive status by HPV16 genotyping of tumor tissue; 3. At least one measurable lesion confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1; 4. Male or female, aged >=18 years; life expectancy >=6 months; Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2; 5. At least 4 weeks since completion of prior treatment, with complete recovery from adverse reactions related to prior treatment; 6. Adequate laboratory parameters, as follows: (1) absolute neutrophil count (ANC) >=1.5 × 10^9/L; (2) TLC >=0.4 × 10^9/L; (3) platelet count (PLT) >=100 × 10^9/L; (4) hemoglobin (Hb) >=9.0 g/dL; (5) serum creatinine (Cr) =1.
Exclusion criteria
Exclusion criteria: 1. Presence of serious concomitant medical conditions, including severe cardiac disease, cerebrovascular disease, uncontrolled diabetes mellitus, uncontrolled hypertension, severe infection, active gastrointestinal ulcer, active bleeding, or other clinically significant conditions; 2. Presence of an immunodeficiency disorder, autoimmune disease, or an infectious disease that is difficult to control; 3. Uncontrolled primary brain tumor or brain metastases; 4. Psychiatric or substance use disorders that may impair the patient’s ability to provide informed consent; 5. Women who are pregnant or breastfeeding; 6. Patients of childbearing potential who are unable or unwilling to use effective contraceptive measures; 7. A history of treatment with immune checkpoint inhibitors, such as PD-1 or PD-L1 inhibitors, resulting in immune-related adverse events (irAEs), including severe pneumonitis, hepatitis, renal impairment, or similar toxicities, that have not fully resolved or cannot be adequately controlled.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events (Frequency, severity);Blood test (antigen-specific immune responses, inflammatory factors, complete blood count, and biochemical analysis indicators); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Overall survival;Complete response;Partial response;Stable disease;Progressive disease;Disease control rate;Tumor microenvironment;Progression-free survival;Time to progression;Time to failure; | — |
Countries
China
Contacts
Public ContactYu Zhao; Jianjun Ren
West China Hospital of Sichuan University
Outcome results
None listed