NCT07738055尚未招募不适用
An Exploratory Study on the Use of Envafolimab Combined With Suvemcitug and HAIC for the Conversion Therapy of Potentially Resectable Hepatocellular Carcinoma
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 35
- 主要终点
- Surgical conversion rate
研究概览
简要总结
This study is a single-center, exploratory clinical trial. Eligible patients with liver cancer, after signing the informed consent form, will be screened and enrolled. They will receive a 3-cycle conversion treatment with Envafolimab combined with Suvemcitug and HAIC. During the treatment process, clinical tumor imaging assessment will be conducted using RECIST V1.1. Imaging evaluations will be performed before treatment and at the end of the 3rd cycle of treatment (±3 days). Subsequently, an MDT assessment will be conducted to determine if the surgical resection criteria are met. If the criteria are met, a radical surgery will be performed based on the subject's wishes and postoperative treatment will be provided. If the criteria are not met, the study will be decided to continue with the original treatment plan or another treatment plan. CTCAE 5.0 will be used for safety assessment. Adverse events will be recorded throughout the study period until 30 days after the end of treatment (for severe adverse events or adverse events related to Envovalimab, the recording period will be extended to 90 days after the end of treatment). To ensure study safety, 3 patients will be enrolled as a safety introduction cohort first, and a 3-cycle conversion treatment with Suvemcitug combined with Envafolimab and HAIC will be used. If a DLT occurs, 3 more patients will be enrolled. If the overall DLT does not exceed 1/3, the original treatment plan will be maintained for the study. If the overall DLT is greater than 1/3, the drug related to the DLT will be re-evaluated and the dose will be adjusted.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sign a written informed consent form before enrollment;
- •Age 18-75 years old;
- •Diagnosed with hepatocellular carcinoma (HCC) by clinical assessment;
- •Patients with stage IV or III unresectable liver cancer;
- •Have measurable lesions (according to the RECIST 1.1 standard, non-lymph node lesions with CT scan diameter ≥ 10 mm, lymph node lesions with CT scan diameter ≥ 15 mm);
- •Have not received any systemic anti-tumor treatment before, including but not limited to immunotherapy, targeted therapy, and anti-tumor traditional Chinese medicine treatment;
- •Child-Pugh score ≤ 7 points;
- •Have sufficient organ function; 1) Blood routine: White blood cell (WBC) ≥ 3.5 × 10^9/L, absolute neutrophil count (ANC) 1.5 × 10^9/L, platelet (PLT) ≥ 100 × 10^9/L, hemoglobin (HGB) ≥ 90 g/L; 2) Liver function: Serum total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN; 3) Kidney function: Serum creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance rate ≥ 50 mL/min (using the standard Cockcroft-Gault formula); 4) Coagulation function: International normalized ratio (INR) ≤ 1.5 / PT ≤ 1.5 × ULN, aPTT ≤ 1.5 × ULN; if the subject is receiving anticoagulation treatment, as long as PT and INR are within the range prescribed by the anticoagulant drug, it is acceptable.
- •10. Estimated survival period ≥ 3 months;
- •Pregnant women should agree to use contraceptive measures (such as intrauterine device, contraceptive pills, or condoms) during the study period and within 6 months after the study; the serum HCG test should be negative within 7 days before enrollment, and must be non-lactating patients; men should agree to use contraceptive measures during the study period and within 6 months after the study.
排除标准
- •Those who refuse to sign the informed consent form or refuse to undergo follow-up;
- •Subjects who have previously or concurrently suffered from other malignant tumors;
- •Patients who have received systemic anti-tumor treatment in the past;
- •Those who are currently candidates for liver transplantation or have undergone liver transplantation;
- •Those with a risk of bleeding, or coagulation dysfunction, or are undergoing thrombolytic therapy; or have experienced esophageal or gastric variceal bleeding within the past 6 months;
- •Subjects who are known to have previously been allergic to large molecule protein preparations or the components of the applied drugs;
- •Subjects with any active autoimmune diseases or a history of autoimmune diseases (as listed below, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, pituitaryitis, vasculitis, nephritis, thyroid dysfunction (hyperthyroidism/hypothyroidism), and the use of drugs that cannot maintain thyroid function within the normal range, or previous thyroid surgery, and long-term thyroid hormone replacement therapy is required after the surgery; subjects with vitiligo or who had completely resolved asthma in childhood and do not require any intervention in adulthood can be included; subjects with asthma who require bronchodilators for medical intervention cannot be included);
- •Subjects who are currently using immunosuppressants, or systemic, or absorbable local hormone treatments to achieve immunosuppression purposes (dose > 10mg/day prednisone or other drugs with equivalent efficacy), and are still using them within 2 weeks before enrollment;
- •Subjects who are using traditional Chinese medicine or other immunomodulatory agents within 2 weeks before enrollment;
- •Have poorly controlled clinical symptoms or diseases of the heart, such as: (1) NYHA grade 2 or above heart failure (2) unstable angina pectoris (3) having had a myocardial infarction within 1 year (4) having clinically significant supraventricular or ventricular arrhythmias that require treatment or intervention;
- •Subjects with congenital or acquired immune deficiencies, such as HIV-infected individuals, or active hepatitis (transaminase does not meet the inclusion criteria, for hepatitis B: HBV DNA ≥ 2000 IU/ml or ≥ 104 copies/ml; for hepatitis C: HCV RNA ≥ 2000 IU/ml or ≥ 104 copies/ml; after nucleotide antiviral treatment, below the above standards can be included); chronic hepatitis B virus carriers, HBV DNA < 104 IU/ml, can be enrolled during the trial period if they must receive antiviral treatment simultaneously;
- •Less than 4 weeks before the study medication, or may have received live vaccines during the study period;
- •Subjects with known history of substance abuse of psychotropic drugs, alcoholism or drug abuse;
- •The investigator considers it necessary to exclude from this study, for example, if the subject is judged by the investigator to have other factors that may cause the study to be prematurely terminated, such as, other serious diseases (including mental disorders) that require combined treatment, severe laboratory test abnormalities, accompanied by family or social factors that may affect the safety of the subject, or the collection of data and samples.
结局指标
主要结局
Surgical conversion rate
时间窗: The conversion rate for the first to third cycles of medication (each cycle lasting 21 days)
次要结局
- Objective Response Rate (ORR)(Objective response rate is defined as the proportion of patients achieving complete response (CR) or partial response (PR) assessed per RECIST v1.1. [Time Frame: During the first to third cycles of medication (each cycle lasting 21 days).])
- Major Pathological Response (MPR)(The assessment will be conducted during the first to third cycles of medication (each cycle lasting 21 days) after the surgery.)
- Progression-Free Survival (PFS)(Time from the first dose of study treatment to the first documented disease progression per RECIST v1.1 or death from any cause, whichever occurs first. [Time Frame: From start of treatment to disease progression or death（Each cycle lasts for 21 days.）])
研究者
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