Study of HX008 in Combination With Bevacizumab or Lenvatinib for the Treatment of Advanced Hepatocellular Carcinoma (HCC)
NCT ID: NCT04741165
Last Updated: 2021-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
72 participants
INTERVENTIONAL
2021-01-07
2022-10-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Experimental: HX008+Bevacizumab
Participants receive HX008 200 mg intravenous (IV) every 3 weeks (Q3W) plus bevacizumab 15 mg/kg, IV, Q3W.
HX008
200 mg administered as IV infusion on Day 1 of each 21-day cycle.
Bevacizumab
15 mg/kg administered as IV infusion on Day 1 of each 21-day cycle.
Experimental: HX008+Lenvatinib
Participants receive HX008 200 mg intravenous (IV) every 3 weeks (Q3W) plus lenvatinib 12 mg (for participants with screening body weight ≥60 kg) or 8 mg (for participants with screening body weight \<60 kg) orally once a day (QD).
HX008
200 mg administered as IV infusion on Day 1 of each 21-day cycle.
Lenvatinib
Administered orally once a day during each 21-day cycle
Interventions
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HX008
200 mg administered as IV infusion on Day 1 of each 21-day cycle.
Bevacizumab
15 mg/kg administered as IV infusion on Day 1 of each 21-day cycle.
Lenvatinib
Administered orally once a day during each 21-day cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 and ≤ 75 years old, male or female.
* Has histologically- or cytologically-confirmed diagnosis of unresectable hepatocellular carcinoma.
* Has Barcelona Clinic Liver Cancer (BCLC) Stage C disease, or BCLC Stage B disease not amenable to locoregional therapy or refractory to locoregional therapy, and not amenable to a curative treatment approach.
* Child-Pugh class A and B (≤7 points).
* Has not received any systematic treatment for HCC.
* Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Score.
* Life expectancy ≥ 3 months.
* Has at least one measurable disease based on RECIST 1.1.
* Has adequate organ function as defined in the protocol.
* Female participants of childbearing potential should have a negative pregnancy within 7 days before the randomization. Male and female participants should agree to use an adequate method of contraception during the experiment and 1 year after the last administration of the test drugs.
Exclusion Criteria
* Diagnosed additional malignancy within 3 years prior to the first dose of trial, with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin,curatively resected in situ cervical or non-muscle invasive bladder cancers.
* Has received locoregional therapy or surgery within 4 weeks prior to the first dose of trial treatment; received palliative radiotherapy or herbal medicine within 2 weeks prior to the first dose of trial treatment;
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
* HBV-DNA\>2000 IU/mL or 10\^4 copy/mL; HCV-RNA\>10\^3 copy/mL.
* Has had esophageal or gastric variceal bleeding within the last 6 months.
* Portal vein tumor thrombus (PVTT) involves both the main trunk and contralateral branch or upper mesenteric vein. Inferior vena cava tumor thrombus.
* Other obvious hemorrhagic tendency or evidence on important coagulation disorder.
* Serious cardiovascular and cerebrovascular diseases.
* Inability to swallow tablets, malabsorption syndrome or any other condition that affects gastrointestinal absorption.
* Serious, uncured wound, active ulcer or untreated bone fracture.
* Uncontrolled pericardial effusion, uncontrolled pleural effusion or clinically obvious moderate peritoneal effusion at screening.
* Has active autoimmune disease that has required systemic treatment in past 2 years.
* Has received a major surgery within 4 weeks prior to the first dose of tiral treatment.
* Has received system treatment with corticosteroids (dose \>10mg/day prednison or other therapeutic hormones) within 2 weeks prior to the first dose of trial treatment.
* Has a history of non-infectious pneumonitis that required steroids or has current pneumonitis.
* Has known active tuberculosis (Bacillus tuberculosis)
* Has a history of testing positive for human immunodeficiency virus (HIV), or known acquired immunodeficiency syndrome (AIDS), or stem cell transplantation or organ transplantation.
* Co-infection of HBV and HCV.
* Any serious acute and chronic infection within 4 weeks prior to the first dose of trial treatment, or infection requiring systemic antibacterial, antifungal or antiviral therapy within 2 weeks prior to the first dose of trial treatment.
* Has participated in other anticancer drug clinical trials within 4 weeks.
* Has received a live vaccine within 30 days prior to the first dose of trial treatment.
* According to the judgement of the investigators, there are other factors that may lead to the termination of the study.
18 Years
75 Years
ALL
No
Sponsors
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Taizhou Hanzhong biomedical co. LTD
INDUSTRY
Responsible Party
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Locations
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The Fist Affiliated Hospital of USTC(Anhui Provincial hospital)
Hefei, Anhui, China
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Beijing Yuhe Integrated Traditional Chinese and Western Medicine Rehabilitation Hospital
Beijing, Beijing Municipality, China
Cancer Hospital Chinese Academy of Medical Sciences, shenzhen center
Shenzhen, Guangdong, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Hunan Provincial People's Hospital
Changsha, Hunan, China
The First Affiliated University of Nanhua University
Hengyang, Hunan, China
The Sixth People's Hospital of Shenyang
Shenyang, Liaoning, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China
The Central Hospital of Lishui City
Lishui, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Lianxin Liu
Role: primary
Jianqiang Cai
Role: primary
Lianhai Zhang
Role: primary
Che Xu
Role: primary
Yuxian Bai
Role: primary
Jufeng Wang
Role: primary
Xiaohai Mao
Role: primary
Wenxiang Dai
Role: primary
Wei Wu
Role: primary
Jing Lv
Role: primary
Bo Li
Role: primary
Tianqiang Song
Role: primary
Jianfei Tu
Role: primary
Other Identifiers
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HX008-II-HCC-01
Identifier Type: -
Identifier Source: org_study_id
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