EUCTR2019-002767-98-IE进行中（未招募）1 期
A Pilot Study of Combined Immune Checkpoint Inhibition in combination with ablative therapies in Subjects with Hepatocellular Carcinoma (HCC) - HCC-TACE study
niversity College Dublin0 个研究点目标入组 13 人开始时间: 2019年10月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 13
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •- Patients must have histopathological confirmation of hepatocellular carcinoma (HCC) prior to entering this study OR histopathological confirmation of carcinoma in the setting of clinical and radiological characteristics which, together with the pathology, are highly suggestive of a diagnosis of HCC. Fibrolamellar variant is also allowed.
- •- Patients must have disease that is not amenable to potentially curative resection, transplantation or ablation. Patients who are BCLC stage C must have progressed on, been intolerant to, or refused prior sorafenib therapy.
- •- Disease must be technically amenable to transhepatic arterial chemoembolization (TACE) and the provision of TACE must be considered to be a reasonable intervention as decided at the HCC tumor board at St Vincents University Hospital (SVUH). Each prospective case will be discussed at this tumor board with interventional radiology and a unanimous consensus across the disciplines of medical oncology, hepatology and interventional radiology must be reached as to the suitability of each patient for this protocol. Patients must have evaluable disease.
- •- If liver cirrhosis is present, patient must have a Child-Pugh A/B7 classification.
- •- Age >18 years
- •- ECOG performance status 0-2
- •- Patients must have normal organ and marrow function.
- •- Patients must have recovered from any acute toxicity related to prior therapy, including surgery. Toxicity should be = grade 1 or returned to baseline.
- •- Patients must not have other invasive malignancies within the past 5 years (with the exception of non-melanoma skin cancers, non-invasive bladder cancer or localized prostate cancer for whom systemic therapy is not required).
- •- Patient must be able to understand and willing to sign a written informed consent document.
- •- Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
- •-Women <50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
- •-Women =50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year ago, had chemotherapy-induced menopause with last menses >1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy. Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 7
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •- Patients who have had standard of care chemotherapy, large field radiotherapy, or major surgery must wait 2 weeks prior to entering the study. For recent experimental therapies a 28 day period of time must elapse before treatment.
- •- Patients who have undergone prior liver transplantation are ineligible.
- •- Patients with known brain metastases will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- •- Uncontrolled intercurrent illness including, but not limited to, ongoing or active systemic infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia (excluding insignificant sinus bradycardia and sinus tachycardia) or psychiatric illness/social situations that would limit compliance with study requirements.
- •- History of chronic autoimmune disease (e.g., Addison’s disease, multiple sclerosis, Graves’ disease, Hashimoto’s thyroiditis, rheumatoid arthritis, hypophysitis, etc.) with symptomatic disease within the 3 years before randomization. Note: Active vitiligo or a history of vitiligo will not be a basis for exclusion.
- •- Dementia or significantly altered mental status that would prohibit the understanding or rendering of Information and Consent and compliance with the requirements of the protocol.
- •- Diverticulitis either active or history of within the past 2 years. Note that diverticulosis is permitted.
- •- Active or history of inflammatory bowel disease (colitis, Crohn’s), irritable bowel disease, celiac disease, or other serious, chronic, gastrointestinal conditions associated with diarrhea. Active or history of systemic lupus erythematosus or Wegener’s granulomatosis.
- •Currently receiving immunosuppressive doses of steroids or other immunosuppressive medications (inhaled and topical steroids are permitted)
- •- History of sarcoidosis syndrome
- •- Patients should not be vaccinated with live attenuated vaccines within 30 days of starting durvalumab or tremelimumab treatment.
- •- Has a known history of Human Immunodeficiency Virus (HIV).
- •HIV-positive patients receiving anti-retroviral therapy are excluded from this study due to the possibility of pharmacokinetic interactions between antiretroviral medications and tremelimumab. HIV positive patients not receiving antiretroviral therapy are excluded due to the possibility that tremelimumab may worsen their condition and the likelihood that the underlying condition may obscure the attribution of adverse events.
- •- History of hypersensitivity reaction to human or mouse antibody products.
- •- Pregnancy and breast feeding are exclusion factors. The effects of tremelimumab on the developing human fetus are unknown. Enrolled patients must agree to use adequate contraception prior to study entry, the duration of study participation and 6 months after the end of the treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
- •- Patients with unhealed surgical wounds for more than 30 days.
研究者
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