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

NCT04741165 | Unknown Phase 2

• 1 other identifier: HX008-II-HCC-01
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 13

Brief 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.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (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.

  Up to approximately 15 months

Secondary Outcomes (6)

• Disease Control Rate (DCR)

  up to approximately 15 months

• Duration of Response (DOR)

  up to approximately 15 months

• Progression-free Survival (PFS)

  up to approximately 15 months

• Overall Survival (OS)

  up to approximately 20 months

• Time to Disease Progression (TTP)

  up to approximately 15 months

Study Arms (2)

Experimental: HX008+Bevacizumab

EXPERIMENTAL

Participants receive HX008 200 mg intravenous (IV) every 3 weeks (Q3W) plus bevacizumab 15 mg/kg, IV, Q3W.

Drug: HX008; Drug: Bevacizumab

Experimental: HX008+Lenvatinib

EXPERIMENTAL

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).

Drug: HX008; Drug: Lenvatinib

Interventions

HX008 DRUG

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

Experimental: HX008+Bevacizumab; Experimental: HX008+Lenvatinib

Bevacizumab DRUG

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

Also known as: AVASTIN®

Experimental: HX008+Bevacizumab

Lenvatinib DRUG

Administered orally once a day during each 21-day cycle

Also known as: LENVIMA®

Experimental: HX008+Lenvatinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taizhou Hanzhong biomedical co. LTD: lead

Study Sites (13)

The Fist Affiliated Hospital of USTC(Anhui Provincial hospital)

Hefei, Anhui, 230001, China

NOT YET RECRUITING

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

Beijing Yuhe Integrated Traditional Chinese and Western Medicine Rehabilitation Hospital

Beijing, Beijing Municipality, 100089, China

RECRUITING

Cancer Hospital Chinese Academy of Medical Sciences, shenzhen center

Shenzhen, Guangdong, 518116, China

NOT YET RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150081, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, 450004, China

NOT YET RECRUITING

Hunan Provincial People's Hospital

Changsha, Hunan, 410000, China

RECRUITING

The First Affiliated University of Nanhua University

Hengyang, Hunan, 421000, China

RECRUITING

The Sixth People's Hospital of Shenyang

Shenyang, Liaoning, 110000, China

RECRUITING

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266000, China

NOT YET RECRUITING

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

NOT YET RECRUITING

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, 300000, China

RECRUITING

The Central Hospital of Lishui City

Lishui, Zhejiang, 323000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Bevacizumab; lenvatinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Jianqiang Cai

CONTACT

010-67781331; caijianqiang188@sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 5, 2021
• Study Start: January 7, 2021
• Primary Completion: April 30, 2022
• Study Completion: October 30, 2022
• Last Updated: February 5, 2021

Record last verified: 2021-02

Locations

CN (13)