2024-516221-31-00招募中2 期
Vaccination with autologous dendritic cells loaded with autologous tumour homogenate after curative resection for stage IV colorectal cancer: a phase II study (COREVAX-1)
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2024年9月16日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Type, incidence, and severity of the adverse events
研究概览
简要总结
Safety and immunological efficacy of the treatment
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed stage IV colorectal cancer surgically treated with radical intent.
- •The patient is willing and able to give written informed consent for the study
- •The autologous surgical specimen must have been collected and sent to the Somatic Cell Therapy Lab of IRST IRCCS and must fulfil all the acceptance criteria prescribed by the GMP procedures.
- •The patient must be disease-free, as assessed by CT scan or MRI of the chest, abdomen, pelvis performed within 60 days before enrolment. If the resected lesions had occurred in other sites, these must be also included in the baseline CT scan and in all the subsequent evaluations
- •The patient must have recovered (grade 1 or less by CTCAE 4.0) from all the adverse events related to previous surgery.
- •Age >18 years
- •ECOG performance status 0 or
- •Patient must have acceptable organ function
- •Patients aged 70 years or older must have left ventricular ejection fraction not lower than 55% as assessed by echocardiography.
- •Female patients of childbearing potential and all male patients must accept and be compliant with an highly effective contraceptive method
排除标准
- •Patients with residual disease after surgery. Marginal resection of any lesion in the absence of clinically evident residual disease is acceptable.
- •Any clinical condition that, in the opinion of the Investigator or the Transfusion Medicine specialist, is a contraindication to leukaphaeresis. In addition, all patients aged 70 or older must be evaluated by a cardiology specialist before the procedure to exclude any clinically relevant cardiac condition and any grade 3-4 cardiac arrhythmia, even if asymptomatic.
- •Any clinical condition that, in the opinion of the Investigator, contraindicates the subcutaneous administration of low-dose IL-2 as per protocol
- •Any uncontrolled serious intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations potentially impacting patient safety and compliance in the opinion of the Investigator.
- •Refusal of giving written informed consent.
- •Patient who completed surgery more than 60 days before study enrolment
- •History of other neoplastic diseases in the previous 5 years, except basal cell carcinoma of the skin and in situ carcinoma of the cervix uteri treated with curative surgery
- •History of congenital or acquired immunodeficiency, including history of organ transplantation.
- •Any positivity for the serologic markers of HBV (including at least anti-HBs antibodies and anti-HBc antibodies), HCV, HIV or Treponema pallidum
- •Female patients who are pregnant or nursing.
- •Patients undergone surgery after preoperatory chemotherapy with a fluoropyrimidine plus oxaliplatin, unless they are not candidate for postoperatory chemotherapy with the same schedule in the opinion of the Investigator (e.g. for unacceptable toxicity) or refuse completion of the perioperatory treatment.
- •Participation in another clinical trial with any investigational agent within 30 days prior to study screening.
- •Any active inflammatory or autoimmune disease requiring systemic steroids or other immunomodulatory agents as detailed in section 6.4, or potentially requiring such treatments during the study treatment in the judgement of the Investigator.
结局指标
主要结局
Type, incidence, and severity of the adverse events
Type, incidence, and severity of the adverse events
Quantification of the circulating immune effectors specific for a selected panel of tumour antigens
Quantification of the circulating immune effectors specific for a selected panel of tumour antigens
Immunohistochemistry on formalin-fixed, paraffin-embedded tumour samples will allow to evaluate the expression of tumour-associated antigen and to characterize the immune infiltrate.
Immunohistochemistry on formalin-fixed, paraffin-embedded tumour samples will allow to evaluate the expression of tumour-associated antigen and to characterize the immune infiltrate.
次要结局
- RFS, OS, TTP
- The potential predictive role of immunological response, as assessed by ELISPOT and DTH skin test, will also be assessed.
- Serum sampling will be performed before the first treatment cycle and at each disease restaging up to two years after treatment, to identify whether changes in markers values eventually found will predict disease relapse.
- Serum sampling will also allow the evaluation of a panel of proinflammatory cytokines during and after treatment
研究者
Francesco De Rosa
Scientific
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
研究点 (1)
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