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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-
- •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.
排除标准
- •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.
- •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.
研究组 & 干预措施
H101+TACE
干预措施: TACE (Procedure)
H101+TACE
干预措施: H101 (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: 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.
次要结局
- Progression-Free Survival (PFS)(From the start of treatment until the first documented progression or death from any cause (assessed up to 24 months).)
- Overall Survival (OS)(From the start of treatment until death from any cause (assessed up to 24 months).)
- Incidence of Treatment-Related Adverse Events (AEs)(From the first administration of H101/TACE until 60 days after the last administration.)