NCT05557838进行中（未招募）3 期
An Open-label, Multi-center Phase IIIb Study of Durvalumab and Tremelimumab as First-Line Treatment in Patients With Unresectable Hepatocellular Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- AstraZeneca
- 入组人数
- 214
- 试验地点
- 29
- 主要终点
- ≥Grade 3 Adverse Events and Adverse Events of Special Interest of Cohort 1
研究概览
简要总结
This is a prospective, open label, multi-center, interventional study to assess the safety and efficacy of Druvalumab plus Tremelimumab as first-line treatment in Chinese patients with unresectable hepatocellular carcinoma.
详细描述
Based on the promising result of HIMALAYA and study 22, this study is going to evaluate the efficacy and safety of Durvalumab plus Tremelimumab in Chinese population and some extended population compared to HIMALAYA, such as Child-Pugh B and, ECOG PS2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •For inclusion in the study, patients should fulfill the following criteria:
- •Provide written informed consent to participate in the study before the start of the study
- •Age ≥18 years at the time of study entry.
- •Body weight >30 kg.
- •Confirmed HCC based on histopathological findings from tumor tissue or radiologically findings.
- •Must not have received prior systemic therapy for HCC.
- •At least 1 measurable lesion, not previously irradiated, that can be accurately measured at baseline as ≥10 mm in the longest diameter (except lymph nodes, which must have a short axis ≥15 mm) with computerized tomography (CT) or magnetic resonance imaging (MRI), and that is suitable for accurate repeated measurements as per RECIST 1.1 guidelines. A lesion which progressed after previous ablation or TACE could be measurable if it meets these criteria.
- •Must not be eligible for locoregional therapy for unresectable HCC. For patients who progressed after locoregional therapy for HCC, locoregional therapy must have been completed ≥28 days prior to the baseline scan for the current study.
- •Barcelona Clinic Liver Cancer (BCLC) stage B (that is not eligible for locoregional therapy) or stage C.
- •Child-Pugh Score classification on liver disease and WHO/ECOG PS at enrolment must comply with one of the following criteria, not cumulatively:
- •Child-Pugh Score class A with WHO/ECOG PS 0-1 at enrolment will be enrolled in cohort1;
- •Child-Pugh class B with WHO/ECOG 0-1 will be enrolled in cohort 2;
- •Child-Pugh class A with WHO/ECOG 2 will be enrolled in cohort 2;
排除标准
- •1) Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
- •2）Previous study drug(s) assignment in the present study. 3）Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
- •4）Have received an investigational product within 28 days prior to the first dose of study drug(s).
- •5) Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria:
- •Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis.
- •Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab or tremelimumab may be included (eg, hearing loss).
- •6) Any concurrent chemotherapy, or biologic or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (eg, hormone replacement therapy) is acceptable.
- •7) Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
- •8) Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 28 days of the first dose of study drug(s).
- •9) Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of study drug(s). Note: Local surgery of isolated lesions for palliative intent is acceptable.
- •10) History of allogeneic organ transplantation (eg, liver transplant). 11）History of hepatic encephalopathy within past 12 months or requirement for medications to prevent or control encephalopathy (eg, no lactulose, rifaximin, etc. if used for purposes of hepatic encephalopathy).
- •12) Clinically meaningful ascites, defined as ascites requiring increasingly frequent non-pharmacologic intervention (eg, paracentesis) and/or escalation in pharmacologic intervention to maintain symptomatic control, within 2 months prior to the first scheduled dose. Subjects on stable doses of diuretics for ascites for ≥2 months are eligible. Also, uncontrolled pleural effusion, pericardial effusion requiring recurrent drainage procedures (once monthly or more frequently) .
- •13）Patients with main portal vein tumor thrombosis (Vp4). 14）Active or prior documented GI bleeding (eg, esophageal varices or ulcer bleeding) within 6 months.
研究组 & 干预措施
cohort 1
Experimental
durvalumab in combination with tremelimumab
干预措施: Tremelimumab (Drug)
cohort 2
Experimental
durvalumab in combination with tremelimumab
干预措施: Durvalumab (Drug)
cohort 1
Experimental
durvalumab in combination with tremelimumab
干预措施: Durvalumab (Drug)
cohort 2
Experimental
durvalumab in combination with tremelimumab
干预措施: Tremelimumab (Drug)
结局指标
主要结局
≥Grade 3 Adverse Events and Adverse Events of Special Interest of Cohort 1
时间窗: From the time of signature of informed consent, throughout the treatment period, and up to the follow-up period, assessed up to 29 months
≥Grade 3 Adverse Events and Adverse Events of Special Interest of Cohort 1
时间窗: From the time of signature of informed consent, throughout the treatment period, and up to the follow-up period, assessed up to 44months
Safety endpoint
次要结局
- Progression Free Survival (PFS) per RECIST v1.1/mRECIST(From first dose of treatment until progression per RECIST 1.1/ mRECIST as assessed by the Investigator or death due to any cause prior to progression, assessed up to 15 months)
- ≥Grade 3 Adverse Events and Adverse Events of Special Interest of Cohort 2(From the time of signature of informed consent, throughout the treatment period, and up to the follow-up period, assessed up to 29 months)
- Overall Survival (OS)(From the first dose of treatment to the date of death, regardless of the actual cause of the subject's death, assessed up to 29 months)
- Rate of Adverse Events(From the time of signature of informed consent, throughout the treatment period, and up to the follow-up period, assessed up to 29 months)
- Objective Response Rate (ORR) per RECIST 1.1/ mRECIST(Until progression, assessed up to 15 months)
- Disease Control Rate (DCR) per RECIST 1.1/ mRECIST(Until progression, assessed up to 15 months)
- Duration of response (DoR) per RECIST 1.1/mRECIST(From the first dose, until progression, assessed up to 15 months)
- ≥Grade 3 Adverse Events and Adverse Events of Special Interest of Cohort 2(From the time of signature of informed consent, throughout the treatment period, and up to the follow-up period, assessed up to 44 months)
- Overall Survival (OS)(From the first dose of treatment to the date of death, regardless of the actual cause of the subject's death, assessed up to 44 months)
研究者
研究点 (29)
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