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Hepatocellular CarcinomaPhase 2NCT04741165

Study of HX008 in Combination With Bevacizumab or Lenvatinib for the Treatment of Advanced Hepatocellular Carcinoma (HCC)

A Phase 2 study testing HX008, Bevacizumab and Lenvatinib in people with Hepatocellular Carcinoma, run by Taizhou Hanzhong biomedical co. LTD at 13 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a multi-center,open-label study to evaluate the efficacy and safety of anti-PD-1 antibody HX008 plus bevacizumab or lenvatinib in the first-line treatment of patients with unresectable hepatocellular carcinoma. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
HX008, Bevacizumab and Lenvatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
13 sitesChina
Study dates
7 Jan 2021to 30 Oct 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Understood and signed an informed consent form.
  • 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.
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  • 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.

Who cannot join

  • Histologically or cytologically documented fibrolamellar hepatocellular carcinoma, sarcoma-like hepatocellular carcinoma, cholangiocarcinoma, etc.
  • 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.
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  • 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.

Trial locations and contacts

13 sites in 1 country.

Jianqiang Cai contact

010-67781331

caijianqiang188@sina.com

13 sites in 1 country

China13 sites, 13 recruiting

  • Cancer Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

    Jianqiang Cai

    Recruiting

  • Beijing Yuhe Integrated Traditional Chinese and Western Medicine Rehabilitation Hospital

    Beijing, Beijing Municipality, 100089

    Lianhai Zhang

    Recruiting

  • Hunan Provincial People's Hospital

    Changsha, Hunan, 410000

    Xiaohai Mao

    Recruiting

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

    Bo Li

    Not yet recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081

    Yuxian Bai

    Recruiting

  • The Fist Affiliated Hospital of USTC(Anhui Provincial hospital)

    Hefei, Anhui, 230001

    Lianxin Liu

    Not yet recruiting

  • The First Affiliated University of Nanhua University

    Hengyang, Hunan, 421000

    Wenxiang Dai

    Recruiting

  • The Central Hospital of Lishui City

    Lishui, Zhejiang, 323000

    Jianfei Tu

    Recruiting

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266000

    Jing Lv

    Not yet recruiting

  • The Sixth People's Hospital of Shenyang

    Shenyang, Liaoning, 110000

    Wei Wu

    Recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences, shenzhen center

    Shenzhen, Guangdong, 518116

    Che Xu

    Not yet recruiting

  • Tianjin Cancer Hospital

    Tianjin, Tianjin Municipality, 300000

    Tianqiang Song

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450004

    Jufeng Wang

    Not yet recruiting

Other trials in China

About this study

Official title: An Open-label, Multicenter, Phase II Clinical Study of HX008 in Combination With Bevacizumab or Lenvatinib in Patients With Advanced Hepatocellular Carcinoma (HCC)

This is a multi-center,open-label study to evaluate the efficacy and safety of anti-PD-1 antibody HX008 plus bevacizumab or lenvatinib in the first-line treatment of patients with unresectable hepatocellular carcinoma.

Being tested
HX008, Bevacizumab, Lenvatinib
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HX008Drug

    200 mg administered as IV infusion on Day 1 of each 21-day cycle.

  • BevacizumabDrug

    Also called AVASTIN®

    15 mg/kg administered as IV infusion on Day 1 of each 21-day cycle.

  • LenvatinibDrug

    Also called LENVIMA®

    Administered orally once a day during each 21-day cycle

Study groups in NCT04741165
Study groupRoleWhat they receive
Experimental: HX008+BevacizumabExperimentalParticipants receive HX008 200 mg intravenous (IV) every 3 weeks (Q3W) plus bevacizumab 15 mg/kg, IV, Q3W.
Receives: Drug: HX008; Drug: Bevacizumab
Experimental: HX008+LenvatinibExperimentalParticipants 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).
Receives: Drug: HX008; Drug: Lenvatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR)

    ORR was defined as the percentage of participants who have a complete response (CR) or a partial response (PR), per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by investigators.

    Measured: Up to approximately 15 months

Secondary outcomes (6)

  1. Disease Control Rate (DCR)

    DCR was defined as the percentage of participants who have a CR or a PR or a stable disease (SD), per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by investigators.

    Measured: up to approximately 15 months

  2. Duration of Response (DOR)

    DOR was defined as the time from the first documented evidence of a response of CR or PR, per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by investigators.

    Measured: up to approximately 15 months

  3. Progression-free Survival (PFS)

    PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 assessed by investigators or death due to any cause, whichever occurs first.

    Measured: up to approximately 15 months

  4. Overall Survival (OS)

    OS was defined as the time from the date of beginning of HX008 administration until date of death from any cause.

    Measured: up to approximately 20 months

  5. Time to Disease Progression (TTP)

    TTP is defined as the time from randomization to the first documented disease progression per RECIST 1.1 as assessed by investigators.

    Measured: up to approximately 15 months

  6. Number of participants with adverse events (AEs)

    An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment

    Measured: up to approximately 20 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2021
  2. Study start7 Jan 2021
  3. Primary completion30 Apr 2022 (estimated)
  4. Study completion30 Oct 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04741165
Sponsor's protocol ID
HX008-II-HCC-01
Status last verified
Feb 2021
First submitted
2 Feb 2021
Last updated
5 Feb 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HX008, Bevacizumab and Lenvatinib in people with Hepatocellular Carcinoma, run by Taizhou Hanzhong biomedical co. LTD at 13 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jianqiang Cai (010-67781331, caijianqiang188@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: Up to approximately 15 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04741165.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2021.

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