NCT05528952招募中2 期
Evaluation of the Interest to Combine a CD4 Th1-inducer Cancer Vaccine Derived From Telomerase and Atezolizumab Plus Bevacizumab in Unresectable Hepatocellular Carcinoma: a Proof of Concept Randomized Phase II Study (TERTIO - Prodige 82)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 105
- 试验地点
- 14
- 主要终点
- objective response rate (ORR)
研究概览
简要总结
The TERTIO trial will propose to determine the clinical interest and immunological efficacy of a treatment combining the CD4 helper T-inducer cancer anti-telomerase vaccine (UCPVax) with anti-PD-L1 therapy (atezolizumab) and bevacizumab in unresectable HCC by evaluation of the objective response rate at 6 months (randomized phase II, 10 centers, 105 patients)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Main inclusion Criteria:
- •Signed informed consent
- •Histologically confirmed hepatocellular carcinoma
- •Locally advanced, metastatic, or unresectable disease
- •Patient who had not previously received systemic anti-cancer treatment
- •Age ≥ 18 years
- •Measurable disease defined according to mRECIST guidelines (Note: Previously irradiated lesions can be considered as measurable disease only if disease progression has been unequivocally documented at that site since radiation.)
- •Patients who have received previous chemoembolization, radioembolization and/or radiotherapy should have recovered from any treatment related toxicity, to a level of ≤ grade 1 (according to National Cancer Institute [NCI] common terminology criteria for adverse events, version 5 (CTCAE v5) with the exception of Grade 2 alopecia
- •Performance status < 2
- •Child-Pugh Class A status
- •BCLC C stage or BCLC B stage not eligible to loco-regional therapy according to the Barcelona Clinic Liver Cancer (BCLC) staging system
排除标准
- •Non-eligible to a clinical trial:
- •Patients previously exposed to anti-tumor immunotherapy as anti-PD-1, anti-PD-L1, or anti-CTLA4 agent or any immune therapy.
- •Diagnosis of additional malignancy within 3 years prior to the inclusion with the exception of curatively treated basal cell carcinoma of the skin and/or curatively resected in situ cervical or breast cancer
- •Patient with any medical or psychiatric condition or disease, which would make the patient inappropriate for entry into this study
- •Current participation in a study of an investigational agent or in the period of exclusion
- •Patient under guardianship, curatorship or under the protection of justice
- •Cancer-specific exclusion criteria:
- •Know fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
- •Uncontrolled pleural effusion, pericardial effusion, ascites or symptomatic fistula
- •Uncontrolled tumor-related pain: exposing patients to risk of exposure to corticoids or iterative hospitalizations. Symptomatic lesions amenable to palliative radiotherapy should be treated prior to inclusion. Patients should be recovered from the effects of radiation. There is no required minimum recovery period
- •Known active central nervous system metastases and/or carcinomatous meningitis. Subject with previously treated brain metastases and with radiological and clinical stability are allowed
- •Non-eligible to treatment:
- •History of encephalopathy
- •Prior bleeding event due to untreated or incompletely treated esophageal and/or gastric varices within 6 months prior to randomization
- •Inadequate organ functions: known cardiac failure of unstable coronaropathy, respiratory failure, or uncontrolled infection or another life-risk condition
研究组 & 干预措施
Experimental Arm (Arm A)
Experimental
Atezolizumab + Bevacizumab + UCPVax
干预措施: Atezolizumab (Drug)
Experimental Arm (Arm A)
Experimental
Atezolizumab + Bevacizumab + UCPVax
干预措施: Bevacizumab (Drug)
Experimental Arm (Arm A)
Experimental
Atezolizumab + Bevacizumab + UCPVax
干预措施: UCPVax (Drug)
Control Arm (Arm B)
Other
Atezoliumab + Bevacizumab
干预措施: Atezolizumab (Drug)
Control Arm (Arm B)
Other
Atezoliumab + Bevacizumab
干预措施: Bevacizumab (Drug)
结局指标
主要结局
objective response rate (ORR)
时间窗: at 6 months
addition of complete response (CR) and partial response (PR) rates, evaluated by mRECIST criteria
次要结局
- progression-free-survival (PFS)(through study completion, an average of 2 years)
- disease control rate (DCR)(at 6 months)
- overall survival (OS)(through study completion, an average of 2 years)
研究者
研究点 (14)
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