Actively Recruiting
Neoadjuvant ICI and Mitochondrial Vaccine for Resectable HNSCC
Led by West China Hospital · Updated on 2026-05-11
9
Participants Needed
2
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Neoadjuvant ICI and Mitochondrial Vaccine for Resectable HNSCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older, any gender.
- Pathologically confirmed head and neck squamous cell carcinoma (HNSCC).
- Clinical stage II to IVB according to the AJCC 8th Edition (nasopharyngeal carcinoma excluded).
- Positive expression of IMP3 protein in the tumor.
- Tumor is clinically resectable as determined by a multidisciplinary team.
- Willing and able to undergo radical surgery.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Adequate organ and bone marrow function, including specific blood counts and liver, kidney, and coagulation parameters.
- Able to voluntarily participate, sign informed consent, and comply with study visits and procedures.
You will not qualify if you...
- History of other malignant tumors within the past 5 years, except certain cured skin, bladder, cervical, or gastrointestinal cancers.
- Active or history of autoimmune diseases including neurological and systemic autoimmune disorders.
- Contraindications for subcutaneous injection such as active skin inflammation, bleeding disorders, or interfering body art at injection site.
- Known allergies to study drugs or excipients, including severe allergic reactions.
- Prior treatment with PD-1, PD-L1, PD-L2, CTLA-4, EGFR antibodies, EGFR-TKIs, or anti-tumor vaccines.
- Receipt of live vaccines within 4 weeks prior to first dose or planned during the study.
- Need for systemic steroids (prednisone >10 mg/day) within 14 days before enrollment.
- Major surgery or severe trauma within 4 weeks prior to first dose.
- Unresolved toxicity from prior anti-tumor therapy above Grade 1 except specific exceptions.
- Severe medical conditions including significant heart dysfunction, poorly controlled diabetes or hypertension, abnormal ECG.
- History or suspicion of interstitial lung disease, non-infectious pneumonitis, active or uncontrolled tuberculosis.
- Hyperthyroidism or organic thyroid disease (stable hypothyroidism allowed).
- Active infection or recent fever within 48 hours before first dose.
- Active Hepatitis B or C, or known HIV/AIDS infection.
- History of neurological or psychiatric disorders like epilepsy or dementia.
- Drug or alcohol abuse within past 3 months.
- Pregnant or lactating women or those planning pregnancy or with unprotected sex until 3 months post-study.
- Receipt of other investigational drugs within 4 weeks prior to first dose or concurrent enrollment in other clinical trials.
- Other factors judged by investigator to interfere with study completion.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
Not Yet Recruiting
2
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
Research Team
X
Xingchen Peng, Professor
CONTACT
Y
Yiyan Pei, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here