H101 Plus TACE for r/m HNSCC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorWest China Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
H101
DrugH101 combined with transarterial chemoembolization (TACE) for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (r/m HNSCC)
TACE
Procedure/SurgeryH101 combined with transarterial chemoembolization (TACE) for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (r/m HNSCC)
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: H101+TACEExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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.
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).Secondary outcomes
1
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.
Time frame
From the start of treatment until the first documented progression or death from any cause (assessed up to 24 months).2
Overall Survival (OS)
The time from the start of treatment to death from any cause.
Time frame
From the start of treatment until death from any cause (assessed up to 24 months).3
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.
Time frame
From the first administration of H101/TACE until 60 days after the last administration.Other outcomes
1
Change in Quality of Life (QoL) Score
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.
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).2
Change in Head and Neck Cancer-Specific Symptoms
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.
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).Sponsors and contacts
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Source ClinicalTrials.gov