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New treatment option for Head and Neck Squamous Cell Carcinoma
Official title H101 Plus TACE for r/m HNSCC
ClinicalTrials.gov ID: NCT07398664
What this study is testing
What is H101?
H101 is an investigational medicine, being studied as a potential treatment for head and neck squamous cell carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Age between 18 and under 80 years old.
- Pathologically confirmed head and neck malignancies (including nasopharyngeal carcinoma, oral cavity cancer, oropharyngeal cancer, laryngeal cancer...
- 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.
You likely can't join if
- 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...
See the full eligibility criteria
- 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...
- 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 \ 60 mL/min.
- Agreement to follow the trial treatment plan and visit schedule, voluntary participation, and written informed consent.
- 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...
- 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...
- 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...
- Other conditions considered by the investigator to potentially affect patient compliance or make the patient unsuitable for participation in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Chengdu, Sichuan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chengdu, Sichuan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.