H101 Plus TACE for r/m HNSCC

February 7, 2026 updated by: Hai Tao, West China Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age between 18 and under 80 years old.
  2. 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).
  3. Expected survival ≥3 months.
  4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-2.
  5. Pre-treatment peripheral blood tests meet the following conditions: neutrophil count >2000/mm³, platelet count >100,000/mm³.
  6. 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.
  7. Agreement to follow the trial treatment plan and visit schedule, voluntary participation, and written informed consent.

Exclusion Criteria:

  1. Expected survival less than 3 months.
  2. Positive pregnancy test for women of childbearing age.
  3. Concurrent diseases or conditions that affect the patient's ability to enroll normally or safety during the study period.
  4. Active psychiatric disorders or other psychological conditions that affect the patient's ability to sign the informed consent or understand the study.
  5. Severe coagulation abnormalities and/or active infection requiring intravenous anti-infective therapy.
  6. 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.
  7. Severe cardiac arrhythmia or conduction abnormalities, and clinically uncontrolled hypertension (systolic blood pressure >150 mmHg and/or diastolic blood pressure >90 mmHg).
  8. 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.).
  9. 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).
  10. Other conditions considered by the investigator to potentially affect patient compliance or make the patient unsuitable for participation in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: H101+TACE
Drug: H101
H101 combined with transarterial chemoembolization (TACE) for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (r/m HNSCC)
Procedure: TACE
H101 combined with transarterial chemoembolization (TACE) for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (r/m HNSCC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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.
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).
The time from the start of treatment to death from any cause.
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.
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.
From the first administration of H101/TACE until 60 days after the last administration.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Quality of Life (QoL) Score
Time Frame: Assessed at baseline, then every 4-8 weeks from the start of treatment until disease progression or study completion (up to 24 months).
The change from baseline in the Global Health Status / Quality of Life scale (Items 29 & 30) of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30. This scale consists of two items rated on a 7-point Likert scale (1='Very poor' to 7='Excellent'). The raw score is linearly transformed to a 0 to 100 scale, with a higher score indicating a better quality of life.
Assessed at baseline, then every 4-8 weeks from the start of treatment until disease progression or study completion (up to 24 months).
Change in Head and Neck Cancer-Specific Symptoms
Time Frame: Assessed at baseline, then every 4-8 weeks from the start of treatment until disease progression or study completion (up to 24 months).
The change from baseline in the total symptom score of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Cancer Module 35. The QLQ-H&N35 assesses symptoms and side effects specific to head and neck cancer and its treatment across multiple domains. Items are rated on a 4-point Likert scale (1='Not at all' to 4='Very much'). Scores are linearly transformed to a 0 to 100 scale, with a higher score indicating more severe symptoms or problems.
Assessed at baseline, then every 4-8 weeks from the start of treatment until disease progression or study completion (up to 24 months).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West China Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 15, 2026

Primary Completion (Estimated)

February 15, 2027

Study Completion (Estimated)

February 15, 2028

Study Registration Dates

First Submitted

January 31, 2026

First Submitted That Met QC Criteria

February 7, 2026

First Posted (Actual)

February 10, 2026

Study Record Updates

Last Update Posted (Actual)

February 10, 2026

Last Update Submitted That Met QC Criteria

February 7, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WCH2025-ONCO-1179

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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