2023-508945-41-00
招募中
2 期
An Open-Label, Prospective, Multi-Center Clinical Trial to Evaluate the Efficacy and Safety of TheraSphere™ Followed by Durvalumab (Imfinzi®) with Tremelimumab (Imjudo®) for Hepatocellular Carcinoma (HCC)
Biocompatibles UK Limited, Biocompatibles UK Limited22 个研究点 分布在 3 个国家目标入组 81 人开始时间: 2023年11月14日最近更新:
概览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Biocompatibles UK Limited, Biocompatibles UK Limited
- 入组人数
- 81
- 试验地点
- 22
- 主要终点
- Primary Effectiveness Endpoint Objective response rate (ORR: complete response and partial response) evaluated by modified Response Evaluation Criteria in Solid Tumors (mRECIST) by investigator assessment Primary Safety Endpoint Number of adverse events (AEs) and serious adverse events (SAEs)
概览
简要总结
To assess the efficacy of treatment with TheraSphere followed by durvalumab and tremelimumab in HCC patients
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Participants must be aged ≥18 years at the time of screening.
- •Adequate renal and marrow function as defined below: a. Hemoglobin (Hgb) ≥9.0 g/dL b. Absolute neutrophil count (ANC) ≥1.0 x 109/L c. Platelet count ≥50 x 109/L d. Measured or calculated creatinine clearance ≥40 mL/min as determined by Cockcroft-Gault (using actual body weight)
- •Absolute lymphocyte count ≥0.5 X 109/L
- •Written informed consent and any locally required authorization (e.g., Health Insurance Portability and Accountability Act in the US, European Union [EU] data privacy regulations in the EU) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
- •Adequate liver function, as defined by a. Child-Pugh A b. Albumin-bilirubin (ALBI) score ≤ -2 with upper limit for(i.e., ALBI score ≤ -grade 1 and subset of ALBI grade 2.). Patients with confirmed Gilbert’s syndrome may not have an evaluable bilirubin value; therefore, ALBI score should not be considered for such patients. Patients with Gilbert’s syndrome will be eligible with any bilirubin value, as long as Albumin level is ≥ 34 g/L. . c. AST and ALT <3 x ULN
- •Body weight >30 kg and BMI ≥18 kg/m
- •Life expectancy ≥6 months
- •HCC, diagnosed by radiographic imaging or histology
- •Patient not a candidate for liver resection, thermal ablation, or transplantation at the time of study entry.
- •ECOG 0 or 1
排除标准
- •Any contraindication to angiography or selective visceral catheterization.
- •Concurrent treatment for HCC or treatment in the last 4 weeks in another clinical study, unless it is an observational study (non-interventional) or during a non-interventional follow-up stage of an interventional study, or prior to inclusion in this study.
- •HCC with infiltrative disease that is not evaluable by mRECIST.
- •Pulmonary insufficiency (defined by an arterial oxygen pressure (PaO2) of <60 mmHg, or oxygen saturation (SaO2) of <90% or clinically evident chronic obstructive pulmonary disease (COPD).
- •Medical history of radiation pneumonitis or recent pneumonitis, regardless of causality
- •History of any organ allograft, including bone marrow allo and autograft.
- •History of active primary/acquired immunodeficiency, that makes patients unsuitable for additional immunotherapy in this study (per investigator and as detailed in exclusion criterion #17).
- •Active or prior documented autoimmune or inflammatory disorders (including but not limited to auto immune hepatitis, inflammatory bowel disease [e.g. ulcerative colitis or Crohn’s disease], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves’ disease, rheumatoid arthritis, hypophysitis, uveitis]). The following are exceptions to this criterion a. Patients with vitiligo or alopecia b. Patients with hypothyroidism (e.g. following Hashimoto’s syndrome) stable on hormone replacement therapy c. Any chronic skin condition that does not require systemic therapy. d. Patients without active disease in the last 5 years may be included but only after consultation with the Sponsor Study physician. e. Patients with celiac disease controlled by diet alone
- •Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion: a. Intranasal, inhaled, topical steroids, or local steroid injections (e.g. intra-articular injection) b. Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent. c. Steroids as premedication for hypersensitivity reactions (e.g. CT scan premedication).
- •History of gastrointestinal bleeding (GI) within 42 days prior to study inclusion, active GI bleeding and any bleeding diathesis or coagulopathy that is not correctable by usual therapy or hemostatic agents (e.g. closure device). Patients with gastrointestinal bleeding related to portal hypertension that cannot be controlled with a non-selective betablocker. Patients with known varices that have not bled or which have been clinically addressed can enter the study. No endoscopic exploration is required before study inclusion.
结局指标
主要结局
Primary Effectiveness Endpoint Objective response rate (ORR: complete response and partial response) evaluated by modified Response Evaluation Criteria in Solid Tumors (mRECIST) by investigator assessment Primary Safety Endpoint Number of adverse events (AEs) and serious adverse events (SAEs)
Primary Effectiveness Endpoint Objective response rate (ORR: complete response and partial response) evaluated by modified Response Evaluation Criteria in Solid Tumors (mRECIST) by investigator assessment Primary Safety Endpoint Number of adverse events (AEs) and serious adverse events (SAEs)
次要结局
- Number of immune mediated AEs and SAEs.
- Number of patients whose durvalumab and/or tremelimumab treatment was temporarily halted, postponed, or permanently discontinued due to an AE.
- Change from baseline in liver function tests (aspartate aminotransferase [AST], alanine aminotransferase [ALT], gamma-glutamyl transpeptidase [GGT], alkaline phosphatase [ALP], bilirubin, albumin).
- Change from baseline in Child-Pugh score
- Change from baseline in Albumin Bilirubin (ALBI) score.
- Change from baseline in Eastern Cooperative Oncology Group (ECOG) score
- ORR according to localized mRECIST# and RECIST 1.1. #Localized mRECIST is defined as mRECIST assessment within the TheraSphere treatment area. The TheraSphere treatment area is the liver volume infused with TheraSphere.
- Disease Control Rate (DCR) according to mRECIST, localized mRECIST#, and RECIST 1.1
- Duration of disease control (DoDC) according to mRECIST, localized mRECIST#, and RECIST 1.1
- Time to best response (Complete Response [CR] or Partial Response [PR]) according to mRECIST, localized mRECIST#, and RECIST 1.1.
- Complete Response Rate (CRR) according to mRECIST, localized mRECIST#, and RECIST 1.1.
- Duration of Complete Response (DoCR) according to mRECIST, localized mRECIST#, and RECIST 1.1.
- Hepatic Time to Progression (hTTP) according to mRECIST, and RECIST 1.1
- Time to Progression (TTP) according to mRECIST, localized mRECIST#, and RECIST 1.1.
- Progression Free Survival (PFS) according to mRECIST, localized mRECIST#, and RECIST 1.1; this will include an evaluation of the PFS rate at 6, 12, 18, and 24 months
- Hepatic Progression Free Survival (hPFS) by mRECIST and RECIST 1.1.
- Overall survival (OS)
- Disease specific survival (DSS)
- Proportion of patients receiving subsequent treatment for HCC after study treatment, and type of HCC treatment received.
- Proportion of patients to undergo surgery (transplantation or resection).
- Time to subsequent anti-cancer treatment for HCC (local or systemic therapy).
- Reason for starting subsequent anti-cancer treatment for HCC
- Alpha-fetoprotein (AFP) response.
- Change from baseline in Quality of Life (QoL) by Functional Assessment of Cancer Therapy – Hepatobiliary (FACT-Hep).
- Change from baseline in QoL by EuroQol-5D (EQ-5D).
- Pre- treatment volumes will be determined using baseline CT/MRI angiography or cone beam computed tomography (CBCT) or single photon emission computerized tomography/computed tomography (SPECT/CT) following Technetium-99m macroaggregated albumin (99mTc-MAA) and Symplicit90Y software
- Association between tumoral absorbed doses, determined by 99mTc-MAA SPECT/CT, with efficacy endpoints
- Association between perfused liver absorbed doses, determined by 99mTc-MAA SPECT/CT, with efficacy endpoints
- Association between normal tissue absorbed doses, determined by 99mTc-MAA SPECT/CT, with safety endpoints.
- Association between tumoral absorbed doses, determined by Y-90 PET/CT or PET/MRI or Y-90 SPECT/CT, with efficacy endpoints
- Association between perfused liver absorbed doses, determined by Y-90 PET/CT or PET/MRI or Y-90 SPECT/CT, with efficacy endpoints.
- Association between normal tissue absorbed doses, determined by 99mTc-MAA SPECT/CT and by Y-90 PET/CT or PET/MRI or Y-90 SPECT/CT
- Determination of dose volume histogram (DVH) for tumoral VOIs and normal liver tissue VOIs, using 99mTc-MAA SPECT/CT and Y-90 PET or SPECT/CT.
- Whole liver and remnant liver volumes at baseline and follow-up volume imaging assessments measured using Simplicit90Y software
- Association between normal tissue absorbed doses, determined by Y-90 PET/CT or PET/MRI or Y-90 SPECT/CT, with safety endpoints.
- Association between tumoral absorbed doses, determined by 99mTc-MAA SPECT/CT and Y-90 PET/CT or PET/MRI or Y-90 SPECT/CT.
- Association between perfused liver absorbed doses, determined by 99mTc-MAA SPECT/CT and Y-90 PET/CT or PET/MRI or Y-90 SPECT/CT.
研究者
BSC Clinical Trials
Scientific
Biocompatibles UK Limited
研究点 (22)
Loading locations...
相似试验
进行中（未招募）
3 期
A Global Study to Assess the Effects of Durvalumab with Oleclumab or Durvalumab with Monalizumab Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer (PACIFIC-9)2023-503999-24-00AstraZeneca AB437
尚未招募
2 期
Perioperative Therapy with Durvalumab Plus Tremelimumab for Patients with Resectable Hepatocellular Carcinoma (HCC) - A Phase II Trial (NEOTOMA)2023-508863-59-01University Health Network10
招募中
2 期
HAIC Combined With Durvalumab and Tremelimumab and Lenvatinib in uHCCHepatocellular CarcinomaNCT06364007Sulai Liu20
招募中
1 期
A Study to Assess the Adverse Events and How Intravenously Infused Livmoniplimab in Combination With Budigalimab Moves Through the Bodies of Adult Chinese Participants With Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC)Hepatocellular Carcinoma (HCC)NCT06487559AbbVie20
招募中
2 期
HAIC Combined With Durvalumab, Tremelimumab and Bevacizumab as Conversion Therapy for Potentially Resectable Hepatocellular CarcinomaUnrescetable Hepatocellular CarcinomaNCT05864755Tianjin Medical University Cancer Institute and Hospital30