Neoadjuvant ICI and Mitochondrial Vaccine for Resectable HNSCC (NCT07572864) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Neoadjuvant ICI and Mitochondrial Vaccine for Resectable HNSCC
China9 participantsStarted 2026-04-28
Plain-language summary
Head and neck squamous cell carcinoma (HNSCC) presents a significant clinical challenge, as over 60% of patients are diagnosed at a locally advanced stage with a high risk of recurrence. Although the landmark KEYNOTE-689 trial established neoadjuvant immune checkpoint inhibitor (ICI) therapy as a new standard of care, the pathological complete response (pCR) rate remains unsatisfactory at only 3.0%, highlighting an urgent need for optimized combination strategies. This prospective, single-arm, single-center clinical study aims to evaluate the safety, tolerability, and preliminary efficacy of a novel neoadjuvant and adjuvant regimen combining an engineered mitochondrial vaccine (IMP3-Mito) with ICIs for patients with resectable, IMP3-positive locally advanced HNSCC. The rationale is based on a "Prime-and-Release" synergistic mechanism: the engineered mitochondrial vaccine serves as a potent "natural adjuvant" to activate dendritic cells and prime tumor-specific T-cell responses against the IMP3 antigen, while the ICI subsequently releases the immune brakes within the tumor microenvironment. By integrating these two modalities, the study seeks to achieve deeper pathological responses and improve long-term survival, while simultaneously providing clinical evidence for the transformative potential of the mitochondrial engineering platform in overcoming the limitations of conventional tumor vaccines.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Aged ≥ 18 years, both genders eligible.
✓. Pathologically confirmed head and neck squamous cell carcinoma (HNSCC) meeting the following criteria:
✓. Clinical stage II-IVB according to the AJCC 8th Edition (nasopharyngeal carcinoma is excluded);
✓. Positive expression of IMP3 protein;
✓. Clinically resectable as determined by a Multidisciplinary Team (MDT);
✓. Subjects must be willing and able to undergo radical surgery.
✓. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
✓. Adequate organ and bone marrow function, defined as:
Exclusion criteria
✕. History of other malignant tumors within the past 5 years, except for cured basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, cervical cancer in situ, gastrointestinal intramucosal carcinoma, or other malignancies that the investigator deems eligible.
What they're measuring
1
Major Pathologic Response
Timeframe: At the time of surgery (approximately 6 weeks after enrollment).
✕. Any active autoimmune disease or history of autoimmune disease, including but not limited to immune-related neurological diseases, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis, systemic lupus erythematosus (SLE), connective tissue disease, scleroderma, inflammatory bowel disease (Crohn's disease and ulcerative colitis), autoimmune hepatitis, toxic epidermal necrolysis (TEN), or Stevens-Johnson syndrome (except for Type I diabetes mellitus on a stable dose of insulin).
✕. Contraindications related to subcutaneous injection (specific to vaccination):
✕. Active inflammation, trauma, or skin breakdown at the intended injection site;
✕. Severe bleeding or coagulation tendency, or significantly reduced platelets/clotting factors assessed by the investigator as high risk for bleeding;
✕. Any abnormal or permanent body art (e.g., tattoos) at the intended injection site that, in the investigator's opinion, would interfere with the observation of local skin reactions.
✕. Known allergy to the study drugs or any excipients. History of severe allergies to any drugs, food, or vaccines (e.g., anaphylactic shock, laryngeal edema, dyspnea, Henoch-Schonlein purpura, thrombocytopenic purpura, or Arthus reaction).
✕. Prior receipt of any of the following treatments: