Head and Neck Squamous Cell CarcinomaPhase 2NCT07572864
Neoadjuvant ICI and Mitochondrial Vaccine for Resectable HNSCC
A Phase 2 study testing Engineered Mitochondrial Vaccine (IMP3-Mito) and Immune checkpoint inhibitor (ICI) in people with Head and Neck Squamous Cell Carcinoma, run by West China Hospital at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Engineered Mitochondrial Vaccine (IMP3-Mito) and Immune checkpoint inhibitor (ICI)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesChina
- Study dates
- 29 Jun 2026to 1 May 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
- Adequate organ and bone marrow function, defined as:
- Hematology: Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L; Platelet count (PLT) ≥ 80 × 10^9/L; Hemoglobin (HGB) ≥ 8 g/dL;
- Liver Function: Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), and Alkaline phosphatase (ALP) ≤ 2.5 × Upper Limit of Normal (ULN); Total bilirubin (TBIL) ≤ 1.5 × ULN;
- Albumin (ALB) ≥ 2.8 g/dL;
- Renal Function: Serum creatinine (Cr) ≤ 1.5 × ULN or Creatinine Clearance (CCR) > 60 mL/min;
- Coagulation: International Normalized Ratio (INR) ≤ 1.5; Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN.
- Subjects must voluntarily participate in the study, sign the Informed Consent Form (ICF), and be able to comply with the scheduled visits and protocol procedures.
Who cannot join
- 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.
- 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.
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- 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:
- Prior treatment with PD-1, PD-L1, PD-L2, CTLA-4, EGFR antibodies, or EGFR-TKIs;
- Prior vaccination with any anti-tumor vaccines;
- Receipt of any live/active vaccines against infectious diseases (e.g., influenza, varicella) within 4 weeks prior to the first dose or planned during the study period.
- Requirement for systemic steroid therapy (prednisone equivalent dose > 10 mg/day) within 14 days prior to enrollment.
- Major surgery or severe trauma within 4 weeks prior to the first dose.
- Toxicity from prior anti-tumor therapy not recovered to ≤ CTCAE (Version 5.0) Grade 1 (except for alopecia, or sequelae of neurotoxicity related to prior platinum therapy) or levels specified in the inclusion/exclusion criteria.
- Severe medical conditions, including: Grade II or higher cardiac dysfunction (NYHA criteria); ischemic heart disease (e.g., myocardial infarction or angina); clinically significant supraventricular or ventricular arrhythmias; poorly controlled diabetes (fasting blood glucose ≥ 10 mmol/L); poorly controlled hypertension (SBP > 150 mmHg and/or DBP > 100 mmHg); LVEF < 50% on echocardiography; QTc interval > 450 msec (males) or > 470 msec (females); or other ECG abnormalities deemed by the investigator to pose extra risk.
- History of interstitial lung disease (ILD), non-infectious pneumonitis, or high suspicion of ILD; or any condition that might interfere with the detection or management of drug-related pulmonary toxicity (except for asymptomatic drug-induced or radiation-induced pneumonitis); active tuberculosis (TB) or history of uncontrolled TB.
- Hyperthyroidism or organic thyroid disease. Hypothyroidism on a stable dose of thyroid replacement therapy or hypothyroidism that can be controlled by replacement therapy (as confirmed by the investigator and/or endocrinology) is eligible.
- Active infection, unexplained fever occurring within 48 hours prior to the first dose, or use of systemic antibiotics within 1 week prior to signing the Informed Consent Form (ICF).
- Active Hepatitis B (HBV DNA ≥ 2000 IU/mL or 10^4 copies/mL), Hepatitis C (HCV antibody positive and HCV RNA above the limit of detection), or known history of HIV infection or AIDS.
- History of neurological or psychiatric disorders, such as epilepsy or dementia.
- History of drug abuse or alcohol abuse within the past 3 months.
- Pregnant or lactating women; subjects (or their partners) planning for pregnancy or engaging in unprotected sexual intercourse from screening until 3 months after the end of the study.
- Receipt of any other investigational drug within 4 weeks prior to the first dose, or concurrent enrollment in another clinical study, except for observational (non-interventional) studies or the follow-up phase of an interventional study.
- Other factors judged by the investigator that may interfere with the completion of the study treatment or follow-up.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Yiyan Pei, Doctor contact
China2 sites, 2 recruiting
- Not yet recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Xingchen Peng, 18980606753, pxx2014@163.com
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Xingchen Peng, Professor, 18980606753, pxx2014@163.com
About this study
Official title: Efficacy and Safety of Immune Checkpoint Inhibitors in Combination With Engineered Mitochondrial Vaccine as Neoadjuvant and Adjuvant Therapy for Resectable Head and Neck Squamous Cell Carcinoma: A Single-Arm, Single-Center Clinical Study.
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
- Head and Neck Squamous Cell Carcinoma
- Being tested
- Engineered Mitochondrial Vaccine (IMP3-Mito), Immune checkpoint inhibitor (ICI)
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Engineered Mitochondrial Vaccine (IMP3-Mito)Biological
A vaccine targeting the IMP3 antigen, utilizing an engineered mitochondrial platform. Administered via subcutaneous injection.
Immune checkpoint inhibitor (ICI)Drug
PD-1 inhibitor administered via intravenous infusion to synergistic with the mitochondrial vaccine.
| Study group | Role | What they receive |
|---|---|---|
| IMP3-Mito Vaccine plus ICI Combination Group | Experimental | Participants with resectable IMP3-positive LA-HNSCC will receive neoadjuvant engineered mitochondrial vaccine (IMP3-Mito) in combination with immune checkpoint inhibitors, followed by surgery and subsequent adjuvant combination therapy. Receives: Biological: Engineered Mitochondrial Vaccine (IMP3-Mito); Drug: Immune checkpoint inhibitor (ICI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Pathologic Response
Major Pathologic Response (MPR) was defined as fewer than 10% viable tumor cells.
Measured: At the time of surgery (approximately 6 weeks after enrollment).
Secondary outcomes (3)
Number of Participants Who Experienced an Adverse Event (AE)
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which was temporally associated with the use of the product was also an AE. The number of participants who experienced an AE was reported for each arm.
Measured: From the first dose until the completion of the 12-month post-operative follow-up (approximately 14 months in total).
Pathologic Complete Response
Pathologic Complete Response (pCR) was defined as the absence of viable tumor cells.
Measured: At the time of surgery (approximately 6 weeks after enrollment).
Objective Response Rate
Objective Response Rate (ORR) was defined as the percentage of participants with a best overall response of CR or PR using RECIST Criteria.
Measured: From the start of neoadjuvant therapy to the end of neoadjuvant therapy, the duration is approximately 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start29 Jun 2026
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xingchen Peng, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07572864
- Sponsor's protocol ID
- 2026(876)
- Status last verified
- Sep 2026
- First submitted
- 24 Apr 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gulley JL, Borre M, Vogelzang NJ, Ng S, Agarwal N, Parker CC, Pook DW, Rathenborg P, Flaig TW, Carles J, Saad F, Shore ND, Chen L, Heery CR, Gerritsen WR, Priou F, Langkilde NC, Novikov A, Kantoff PW. Phase III Trial of PROSTVAC in Asymptomatic or Minimally Symptomatic Metastatic Castration-Resistant Prostate Cancer. J Clin Oncol. 2019 May 1;37(13):1051-1061. doi: 10.1200/JCO.18.02031. Epub 2019 Feb 28.
PubMed 30817251Fan L, Wu D, Goremykin V, Xiao J, Xu Y, Garg S, Zhang C, Martin WF, Zhu R. Phylogenetic analyses with systematic taxon sampling show that mitochondria branch within Alphaproteobacteria. Nat Ecol Evol. 2020 Sep;4(9):1213-1219. doi: 10.1038/s41559-020-1239-x. Epub 2020 Jul 13.
PubMed 32661403Pierini S, Fang C, Rafail S, Facciponte JG, Huang J, De Sanctis F, Morgan MA, Uribe-Herranz M, Tanyi JL, Facciabene A. A Tumor Mitochondria Vaccine Protects against Experimental Renal Cell Carcinoma. J Immunol. 2015 Oct 15;195(8):4020-7. doi: 10.4049/jimmunol.1500281. Epub 2015 Sep 16.
PubMed 26378078Tse SW, McKinney K, Walker W, Nguyen M, Iacovelli J, Small C, Hopson K, Zaks T, Huang E. mRNA-encoded, constitutively active STINGV155M is a potent genetic adjuvant of antigen-specific CD8+ T cell response. Mol Ther. 2021 Jul 7;29(7):2227-2238. doi: 10.1016/j.ymthe.2021.03.002. Epub 2021 Mar 5.
PubMed 33677092Fang C, Mo F, Liu L, Du J, Luo M, Men K, Na F, Wang W, Yang H, Wei X. Oxidized mitochondrial DNA sensing by STING signaling promotes the antitumor effect of an irradiated immunogenic cancer cell vaccine. Cell Mol Immunol. 2021 Sep;18(9):2211-2223. doi: 10.1038/s41423-020-0456-1. Epub 2020 May 12.
PubMed 32398808Luo J, Mo F, Zhang Z, Hong W, Lan T, Cheng Y, Fang C, Bi Z, Qin F, Yang J, Zhang Z, Li X, Que H, Wang J, Chen S, Wu Y, Yang L, Li J, Wang W, Chen C, Wei X. Engineered mitochondria exert potent antitumor immunity as a cancer vaccine platform. Cell Mol Immunol. 2024 Nov;21(11):1251-1265. doi: 10.1038/s41423-024-01203-4. Epub 2024 Aug 20.
PubMed 39164536
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Immune Checkpoint Inhibitors in Combination With Engineered Mitochondrial Vaccine as Neoadjuvant and Adjuvant Therapy for Resectable Head and Neck Squamous Cell Carcinoma: A Single-Arm, Single-Center Clinical Study.
- ClinicalTrials.gov ID
- NCT07572864
- Acronym / sponsor ID
- 2026(876)
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 29 Jun 2026 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 7 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IMP3-Mito Vaccine plus ICI Combination Group | Experimental | Biological: Engineered Mitochondrial Vaccine (IMP3-Mito), Drug: Immune checkpoint inhibitor (ICI)Participants with resectable IMP3-positive LA-HNSCC will receive neoadjuvant engineered mitochondrial vaccine (IMP3-Mito) in combination with immune checkpoint inhibitors, followed by surgery and subsequent adjuvant combination therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Aged ≥ 18 years, both genders eligible.
- Pathologically confirmed head and neck squamous cell carcinoma (HNSCC) meeting the following criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
- Adequate organ and bone marrow function, defined as:
- Subjects must voluntarily participate in the study, sign the Informed Consent Form (ICF), and be able to comply with the scheduled visits and protocol procedures.
Key exclusion criteria (24 listed)
- 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.
- 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):
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Engineered Mitochondrial Vaccine (IMP3-Mito)A vaccine targeting the IMP3 antigen, utilizing an engineered mitochondrial platform. Administered via subcutaneous injection. | Biological | IMP3-Mito Vaccine plus ICI Combination Group |
| Immune checkpoint inhibitor (ICI)PD-1 inhibitor administered via intravenous infusion to synergistic with the mitochondrial vaccine. | Drug | IMP3-Mito Vaccine plus ICI Combination Group |
Primary outcome
Major Pathologic Response
Time frame: At the time of surgery (approximately 6 weeks after enrollment).
Major Pathologic Response (MPR) was defined as fewer than 10% viable tumor cells.
3 secondary outcomes
Number of Participants Who Experienced an Adverse Event (AE)
Time frame: From the first dose until the completion of the 12-month post-operative follow-up (approximately 14 months in total).
Pathologic Complete Response
Time frame: At the time of surgery (approximately 6 weeks after enrollment).
Objective Response Rate
Time frame: From the start of neoadjuvant therapy to the end of neoadjuvant therapy, the duration is approximately 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Background: PubMed 30817251Gulley JL, Borre M, Vogelzang NJ, Ng S, Agarwal N, Parker CC, Pook DW, Rathenborg P, Flaig TW, Carles J, Saad F, Shore ND, Chen L, Heery CR, Gerritsen WR, Priou F, Langkilde NC, Novikov A, Kantoff PW. Phase III Trial of PROSTVAC in Asymptomatic or Minimally Symptomatic Metastatic Castration-Resistant Prostate Cancer. J Clin Oncol. 2019 May 1;37(13):1051-1061. doi: 10.1200/JCO.18.02031. Epub 2019 Feb 28.
- Background: PubMed 32661403Fan L, Wu D, Goremykin V, Xiao J, Xu Y, Garg S, Zhang C, Martin WF, Zhu R. Phylogenetic analyses with systematic taxon sampling show that mitochondria branch within Alphaproteobacteria. Nat Ecol Evol. 2020 Sep;4(9):1213-1219. doi: 10.1038/s41559-020-1239-x. Epub 2020 Jul 13.
- Background: PubMed 26378078Pierini S, Fang C, Rafail S, Facciponte JG, Huang J, De Sanctis F, Morgan MA, Uribe-Herranz M, Tanyi JL, Facciabene A. A Tumor Mitochondria Vaccine Protects against Experimental Renal Cell Carcinoma. J Immunol. 2015 Oct 15;195(8):4020-7. doi: 10.4049/jimmunol.1500281. Epub 2015 Sep 16.
- Background: PubMed 33677092Tse SW, McKinney K, Walker W, Nguyen M, Iacovelli J, Small C, Hopson K, Zaks T, Huang E. mRNA-encoded, constitutively active STINGV155M is a potent genetic adjuvant of antigen-specific CD8+ T cell response. Mol Ther. 2021 Jul 7;29(7):2227-2238. doi: 10.1016/j.ymthe.2021.03.002. Epub 2021 Mar 5.
- Background: PubMed 32398808Fang C, Mo F, Liu L, Du J, Luo M, Men K, Na F, Wang W, Yang H, Wei X. Oxidized mitochondrial DNA sensing by STING signaling promotes the antitumor effect of an irradiated immunogenic cancer cell vaccine. Cell Mol Immunol. 2021 Sep;18(9):2211-2223. doi: 10.1038/s41423-020-0456-1. Epub 2020 May 12.
- Background: PubMed 39164536Luo J, Mo F, Zhang Z, Hong W, Lan T, Cheng Y, Fang C, Bi Z, Qin F, Yang J, Zhang Z, Li X, Que H, Wang J, Chen S, Wu Y, Yang L, Li J, Wang W, Chen C, Wei X. Engineered mitochondria exert potent antitumor immunity as a cancer vaccine platform. Cell Mol Immunol. 2024 Nov;21(11):1251-1265. doi: 10.1038/s41423-024-01203-4. Epub 2024 Aug 20.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yiyan Pei, Doctor contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Engineered Mitochondrial Vaccine (IMP3-Mito) and Immune checkpoint inhibitor (ICI) in people with Head and Neck Squamous Cell Carcinoma, run by West China Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xingchen Peng, Professor (+8618980606753, pxx2014@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Pathologic Response (time frame: At the time of surgery (approximately 6 weeks after enrollment).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07572864, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.