Neoadjuvant ICI and Mitochondrial Vaccine for Resectable HNSCC
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek powyżej 18 lat
- •Potwierdzony rak płaskonabłonkowy głowy i szyi w stopniu II-IVB
- •Dodatnia obecność białka IMP3 w guzie
- •Guz powinien być operacyjny (możliwy do usunięcia chirurgicznie)
- •Pacjent w dobrym ogólnym stanie zdrowia (ECOG 0-1)
- •Prawidłowe wyniki badań krwi, wątroby i nerek
- •Dobrowolna zgoda na udział w badaniu
✗ Disqualifies
- •Inne nowotwory w ciągu ostatnich 5 lat
- •Choroby autoimmunologiczne w historii medycznej (np. łupież, stwardnienie rozsiane, miastenia)
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- August 7, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (2)
West China Hospital, Sichuan University
Chengdu, China
West China Hospital, Sichuan University
Chengdu, China
Trial contact
Xingchen Peng, Professor
Yiyan Pei, Doctor
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/8/2026.
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