Head and Neck Squamous Cell CarcinomaPhase 2NCT07398664
H101 Plus TACE for r/m HNSCC
A Phase 2 study testing H101 and TACE in people with Head and Neck Squamous Cell Carcinoma and Oncolytic Virus, run by West China Hospital at 1 site in China.
Trial summary
This study evaluates H101 combined with transarterial chemoembolization (TACE) to enhance local tumor killing and immune activation while minimizing toxicity in r/m HNSCC patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma, Oncolytic Virus, TACE
- What is being tested?
- H101 and TACE
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 2 Mar 2026to 15 Dec 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and under 80 years old.
- Pathologically confirmed head and neck malignancies (including nasopharyngeal carcinoma, oral cavity cancer, oropharyngeal cancer, laryngeal cancer, hypopharyngeal cancer, salivary gland cancer, nasal cavity and paranasal sinus cancer, etc.); patients who have failed at least two lines of standard treatment (including cetuximab and immuno check point inhibitors).
- Expected survival ≥3 months.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-2.
- Pre-treatment peripheral blood tests meet the following conditions: neutrophil count >2000/mm³, platelet count >100,000/mm³.
- Pre-treatment liver and kidney function meet the following: bilirubin <1.5 mg/dL, AST or ALT <1.5 times the upper limit of normal, serum creatinine <1.5 mg/dL, creatinine clearance >60 mL/min.
- Agreement to follow the trial treatment plan and visit schedule, voluntary participation, and written informed consent.
Who cannot join
- Expected survival less than 3 months.
- Positive pregnancy test for women of childbearing age.
- Concurrent diseases or conditions that affect the patient's ability to enroll normally or safety during the study period.
- Active psychiatric disorders or other psychological conditions that affect the patient's ability to sign the informed consent or understand the study.
- Severe coagulation abnormalities and/or active infection requiring intravenous anti-infective therapy.
- History of another malignancy within 5 years prior to screening, except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or microscopic papillary thyroid carcinoma that have been treated with potential curative therapy.
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- Severe cardiac arrhythmia or conduction abnormalities, and clinically uncontrolled hypertension (systolic blood pressure >150 mmHg and/or diastolic blood pressure >90 mmHg).
- Adverse reactions from prior anti-tumor treatments have not recovered to CTCAE version 5.0 Grade <1 (except for toxicities judged by the investigator to pose no safety risk, such as alopecia, Grade 2 peripheral neuropathy, etc.).
- History of infectious diseases, such as positive HIV antibody test, active hepatitis B (defined as HBsAg positive during screening, with HBV-DNA levels above the upper limit of normal at the local laboratory), or hepatitis C (defined as positive HCV-Ab test during screening with positive HCV-RNA).
- Other conditions considered by the investigator to potentially affect patient compliance or make the patient unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
West China hospital
Chengdu, Sichuan, 610041
Tao Hai, 028-85422654, haitao42@hotmail.com
About this study
Official title: Recombinant Human Adenovirus 5 (H101) Combined With Transcatheter Arterial Chemoembolization (TACE) for the Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma: A Single-Center, Prospective Study
This study evaluates H101 combined with transarterial chemoembolization (TACE) to enhance local tumor killing and immune activation while minimizing toxicity in r/m HNSCC patients.
Read the detailed description
Recurrent or metastatic head and neck squamous cell carcinoma (r/m HNSCC) carries a dismal prognosis (median OS 7-9 months) and lacks effective treatments. H101, an oncolytic adenovirus approved for nasopharyngeal carcinoma, selectively lyses p53-deficient tumor cells [3]. This study evaluates H101 combined with transarterial chemoembolization (TACE) to enhance local tumor killing and immune activation while minimizing toxicity. Supported by prior safety and efficacy data of both modalities, this regimen represents a promising novel approach for r/m HNSCC.
- Conditions
- Head and Neck Squamous Cell Carcinoma, Oncolytic Virus, TACE
- Being tested
- H101, TACE
- 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.
H101Drug
H101 combined with transarterial chemoembolization (TACE) for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (r/m HNSCC)
TACEProcedure or surgery
H101 combined with transarterial chemoembolization (TACE) for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (r/m HNSCC)
| Study group | Role | What they receive |
|---|---|---|
| H101+TACE | Experimental | Not described Receives: Drug: H101; Procedure: TACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
The proportion of participants achieving a complete response (CR) or partial response (PR) based on modified RECIST v1.1 (mRECIST) criteria for target lesions assessed via MRI or CT imaging.
Measured: Tumor assessments performed at baseline, then every 6-12 weeks from the start of treatment until disease progression or study completion (up to 24 months).
Secondary outcomes (3)
Progression-Free Survival (PFS)
The time from the start of treatment to the first occurrence of disease progression as per mRECIST criteria or death from any cause, whichever occurs first.
Measured: From the start of treatment until the first documented progression or death from any cause (assessed up to 24 months).
Overall Survival (OS)
The time from the start of treatment to death from any cause.
Measured: From the start of treatment until death from any cause (assessed up to 24 months).
Incidence of Treatment-Related Adverse Events (AEs)
The frequency and severity of adverse events assessed according to CTCAE v5.0, including those related to the oncolytic virus H101 and transarterial chemoembolization (TACE), such as injection site reactions, flu-like symptoms, myelosuppression, and procedural complications.
Measured: From the first administration of H101/TACE until 60 days after the last administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start2 Mar 2026
- Primary completion15 Jun 2028 (estimated)
- Study completion15 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hai Tao, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07398664
- Sponsor's protocol ID
- WCH2025-ONCO-1179
- Status last verified
- Jul 2026
- First submitted
- 31 Jan 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recombinant Human Adenovirus 5 (H101) Combined With Transcatheter Arterial Chemoembolization (TACE) for the Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma: A Single-Center, Prospective Study
- ClinicalTrials.gov ID
- NCT07398664
- Acronym / sponsor ID
- WCH2025-ONCO-1179
- Conditions
- Head and Neck Squamous Cell Carcinoma, Oncolytic Virus, TACE
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- 15 Jun 2028 (estimated)
- Study completion
- 15 Dec 2028 (estimated)
- First posted
- 10 Feb 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.
This study evaluates H101 combined with transarterial chemoembolization (TACE) to enhance local tumor killing and immune activation while minimizing toxicity in r/m HNSCC patients.
Detailed description
Recurrent or metastatic head and neck squamous cell carcinoma (r/m HNSCC) carries a dismal prognosis (median OS 7-9 months) and lacks effective treatments. H101, an oncolytic adenovirus approved for nasopharyngeal carcinoma, selectively lyses p53-deficient tumor cells [3]. This study evaluates H101 combined with transarterial chemoembolization (TACE) to enhance local tumor killing and immune activation while minimizing toxicity. Supported by prior safety and efficacy data of both modalities, this regimen represents a promising novel approach for r/m HNSCC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| H101+TACE | Experimental | Drug: H101, Procedure: TACE |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age between 18 and under 80 years old.
- Pathologically confirmed head and neck malignancies (including nasopharyngeal carcinoma, oral cavity cancer, oropharyngeal cancer, laryngeal cancer, hypopharyngeal cancer, salivary gland cancer, nasal cavity and paranasal sinus cancer, etc.); patients who have failed at least two lines of standard treatment (including cetuximab and immuno check point inhibitors).
- Expected survival ≥3 months.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-2.
- Pre-treatment peripheral blood tests meet the following conditions: neutrophil count >2000/mm³, platelet count >100,000/mm³.
Key exclusion criteria (10 listed)
- Expected survival less than 3 months.
- Positive pregnancy test for women of childbearing age.
- Concurrent diseases or conditions that affect the patient's ability to enroll normally or safety during the study period.
- Active psychiatric disorders or other psychological conditions that affect the patient's ability to sign the informed consent or understand the study.
- Severe coagulation abnormalities and/or active infection requiring intravenous anti-infective therapy.
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 |
|---|---|---|
| H101H101 combined with transarterial chemoembolization (TACE) for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (r/m HNSCC) | Drug | H101+TACE |
| TACEH101 combined with transarterial chemoembolization (TACE) for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (r/m HNSCC) | Procedure or surgery | H101+TACE |
Primary outcome
Objective Response Rate (ORR)
Time frame: Tumor assessments performed at baseline, then every 6-12 weeks from the start of treatment until disease progression or study completion (up to 24 months).
The proportion of participants achieving a complete response (CR) or partial response (PR) based on modified RECIST v1.1 (mRECIST) criteria for target lesions assessed via MRI or CT imaging.
3 secondary outcomes
Progression-Free Survival (PFS)
Time frame: From the start of treatment until the first documented progression or death from any cause (assessed up to 24 months).
Overall Survival (OS)
Time frame: From the start of treatment until death from any cause (assessed up to 24 months).
Incidence of Treatment-Related Adverse Events (AEs)
Time frame: From the first administration of H101/TACE until 60 days after the last administration.
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 Jul 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing H101 and TACE in people with Head and Neck Squamous Cell Carcinoma and Oncolytic Virus, run by West China Hospital at 1 site 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 7 inclusion and 10 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 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Tao Hai (086-18982770417, haitao42@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: Tumor assessments performed at baseline, then every 6-12 weeks from the start of treatment until disease progression or study completion (up to 24 months).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2026.