NCT06441019尚未招募2 期
Efficacy and Safety of HAIC in Combination With TQB2868 and Ramucirumab for Second-line Treatment of Advanced Hepatocellular Carcinoma: an Open, Single-arm Exploratory Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
In recent years, with the emergence of various new targeted and immunotherapy drugs, drug therapy for advanced Hepatocellular carcinoma has also seen continuous breakthroughs. The effective rate, progression free survival, and overall survival of advanced Hepatocellular carcinoma have all significantly improved. At present, internationally recognized first-line treatments available include atezolizumab+bevacizumab (T+A), lenvatinib, sorafenib, Durvalumab+tremelimumab, etc. However, the effective rate of first-line treatment has not exceeded 50%, and most patients face difficulties such as drug resistance or treatment failure. Second line treatment for Hepatocellular carcinoma still faces many difficulties and challenges. The aim of this study is to explore the effectiveness and safety of HAIC combined with TQB2868 and Ramucirumab in second-line treatment of advanced HCC patients.
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
- •Male or non-pregnant female aged 18-80 years or older;
- •Signed informed consent form;
- •The investigator believes that the patient is capable of complying with the study protocol;
- •Histologically or cytologically confirmed advanced hepatocellular carcinoma (HCC);
- •Patients who have received first-line treatment for hepatocellular carcinoma and have treatment failure or intolerance;
- •No prior treatment with HAIC including oxaliplatin;
- •Prior treatment with tyrosine kinase inhibitors (TKIs) and/or immunotherapy is allowed;
- •At least one measurable, untreated lesion according to RECIST 1.1 criteria;
- •Availability of pretreatment tumor tissue sample, if available. If tumor tissue is not available (e.g., exhausted by previous diagnostic testing), the patient remains eligible for participation in the study;
- •ECOG performance status of 0 or 1 within 14 days prior to enrollment;
- •Child-Pugh class A or B ≤7 within 14 days prior to enrollment;
- •Adequate hematologic and organ function;
- •Any acute clinically significant treatment-related toxicity (from prior therapy) must have resolved to ≤Grade 1 prior to enrollment, except for alopecia;
- •Negative HIV antibody test result at screening;
- •Patients with active hepatitis B virus (HBV) infection: HBV DNA <2000 IU/mL obtained within 28 days prior to starting study treatment and at least 7 days of antiviral treatment (according to local standard of care, e.g., entecavir) prior to enrollment and willingness to continue treatment during the study; Patients with active hepatitis C virus (HCV) infection: HCV RNA <2000 IU/mL obtained within 28 days prior to starting study treatment and at least 7 days of antiviral treatment prior to enrollment and willingness to continue treatment during the study;
- •Women of childbearing potential must have a negative pregnancy test (β-HCG) prior to initiation of treatment, and women of childbearing potential and men (who engage in sexual intercourse with women of childbearing potential) must agree to use effective contraception continuously during the treatment period and for 6 months after the last dose of treatment.
排除标准
- •Previous treatment with HAIC containing oxaliplatin;
- •Expected survival time less than 3 months
- •History of meningitis;
- •Current or past autoimmune diseases or immunodeficiency;
- •Idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonia, or idiopathic pneumonia, or evidence of active pneumonia on screening computed tomography (CT) scan. Prior radiation pneumonitis in the radiation field (fibrosis) is allowed;
- •Known active tuberculosis;
- •Significant cardiovascular disease within 3 months prior to starting study treatment (e.g., New York Heart Association Class II or greater heart disease, myocardial infarction, or cerebrovascular accident), unstable arrhythmia, or unstable angina;
- •History of congenital long QT syndrome or corrected QT interval >500ms (calculated using Fridericia's method) at screening;
- •History of uncorrectable electrolyte disturbances such as serum potassium, calcium, or magnesium imbalances;
- •Major surgery within 4 weeks prior to starting study treatment (excluding diagnostic procedures) or anticipation of need for major surgical procedure during the course of the study;
- •History of malignancy other than HCC within 5 years prior to screening, unless the risk of recurrence or death from the previous malignancy is considered negligible (e.g., 5-year overall survival rate >90%) and adequately treated in situ cervical cancer, non-melanoma skin cancer, localized prostate cancer, in situ ductal carcinoma, or stage I uterine cancer;
- •Severe infection within 4 weeks prior to starting study treatment, including but not limited to hospitalization for complications of infection, sepsis, or severe pneumonia;
- •Treatment with therapeutic antibiotics orally or intravenously within 2 weeks prior to starting study treatment. Patients receiving prophylactic antibiotics (e.g., for prevention of urinary tract infection or exacerbation of chronic obstructive pulmonary disease) are eligible for participation in the study;
- •Prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation;
- •Receipt of attenuated live vaccines within 4 weeks prior to starting study treatment or anticipated need for such vaccines within 5 months after the last dose of PD-1 antibody therapy;
- •Untreated or incompletely treated esophageal and/or gastric varices associated with bleeding or patients at high risk of bleeding;
- •Concurrent HBV and HCV infection. Patients with a history of HCV infection but negative HCV RNA PCR results can be considered not infected with HCV;
- •Symptomatic, untreated, or gradually progressing central nervous system (CNS) metastases;
- •Inability to comply with follow-up or concurrent participation in another clinical trial that may interfere with this study;
- •The investigator deems the patient unsuitable for enrollment.
研究组 & 干预措施
HAIC combined with TQB2868 and Ramucirumab
Experimental
干预措施: HAIC（Oxaliplatin+ Raltitrexed）、TQB2868、Ramucirumab (Drug)
结局指标
主要结局
Objective response rate
时间窗: 24 months
The proportion of patients whose tumors have shrunk to a certain amount and maintained for a certain period of time, including complete response and partial response
次要结局
- Progression-Free Survival (PFS)(Up to approximately 1 years)
- Overall Survival (OS)(Up to approximately 2 years)
- Incidence of Adverse Events and Treatment-Emergent Adverse Events(Up to approximately 2 years)
- Disease Control Rate (DCR)(6 months)
研究者
Lu Wang, MD, PhD
Chief physician
Fudan University
研究点 (1)
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