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

Hepatocellular Carcinoma Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04741165
• Other study ID #: HX008-II-HCC-01
• Status: Recruiting
• Phase: Phase 2
• Start date: January 7, 2021
• Est. completion date: October 30, 2022

Study information

• Verified date: February 2021
• Source: Taizhou Hanzhong biomedical co. LTD
• Contact: Jianqiang Cai
• Phone: 010-67781331
• Email: caijianqiang188[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: October 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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.

• 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:

• 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.

• 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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• 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

Locations

Country	Name	City	State
China	Beijing Yuhe Integrated Traditional Chinese and Western Medicine Rehabilitation Hospital	Beijing	Beijing
China	Cancer Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing
China	Hunan Provincial People's Hospital	Changsha	Hunan
China	West China Hospital, Sichuan University	Chengdu	Sichuan
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang
China	The Fist Affiliated Hospital of USTC(Anhui Provincial hospital)	Hefei	Anhui
China	The First Affiliated University of Nanhua University	Hengyang	Hunan
China	The Central Hospital of Lishui City	Lishui	Zhejiang
China	The Affiliated Hospital of Qingdao University	Qingdao	Shandong
China	The Sixth People's Hospital of Shenyang	Shenyang	Liaoning
China	Cancer Hospital Chinese Academy of Medical Sciences, shenzhen center	Shenzhen	Guangdong
China	Tianjin Cancer Hospital	Tianjin	Tianjin
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Taizhou Hanzhong biomedical co. LTD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to approximately 15 months
Secondary	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.	up to approximately 15 months
Secondary	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.	up to approximately 15 months
Secondary	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.	up to approximately 15 months
Secondary	Overall Survival (OS)	OS was defined as the time from the date of beginning of HX008 administration until date of death from any cause.	up to approximately 20 months
Secondary	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.	up to approximately 15 months
Secondary	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	up to approximately 20 months