Clinical Trials/NCT03973112

NCT03973112

Unknown

Phase 2

A Single-arm, Open, Multicenter, Phase II Clinical Study Evaluating the Use of HLX10 (Recombinant Anti-pd-1 Humanized Monoclonal Antibody Injection) in Combination With HLX04 (Recombinant Anti-vegf Humanized Monoclonal Antibody Injection) for the Treatment of Advanced Hepatocellular Carcinoma (HCC) Patients

Shanghai Henlius Biotech1 site in 1 country123 target enrollmentSeptember 24, 2019

ConditionsHepatocellular Carcinoma

InterventionsHLX10 3mg/kg HLX04 10mg/kg HLX04 5mg/kg

DrugsHLX10 3mg/kg HLX04 5mg/kg HLX04 10mg/kg

Overview

Phase: Phase 2
Intervention: HLX10 3mg/kg
Conditions: Hepatocellular Carcinoma
Sponsor: Shanghai Henlius Biotech
Enrollment: 123
Locations: 1
Primary Endpoint: ORR
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials Related News

Overview

Brief Summary

This trial is a single-arm, open, multicenter phase II clinical study.Subjects can only enter this study after they meet the inclusion and exclusion criteria.Into subjects will accept HLX10 + HLX04 intravenous infusion, every two weeks, lose treatment until clinical benefit, toxicity, the subjects of the resistance or the doctor decided to suspend the treatment, tested subjects death revocation of informed consent, subjects, subjects of pregnancy, not to plan or program requirement from, or management reasons, treatment for up to 2 years (before).

Registry

clinicaltrials.gov

Start Date

September 24, 2019

End Date

December 15, 2022

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shanghai Henlius Biotech

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects who meet all of the following criteria are allowed to be enrolled into this study:
•Volunteer to participate in clinical research;To fully understand and understand this study and to sign the Informed Consent Form (ICF);Willing to follow and able to complete all test procedures.
•The age of signing ICF is ≥ 18 years old and ≤ 75 years old.
•Subjects with advanced hepatocellular carcinoma (HCC) diagnosed by histopathology or cytology, or clinically diagnosed as meeting the criteria for hepatocellular carcinoma of the American association of liver diseases (AASLD).
•arm A、B Failure or intolerable toxicity after at least one standard first-line systemic treatment for advanced hepatocellular carcinoma.Previous standard first-line systemic therapy included sorafenib, renvastinib and oxaliplatin based chemotherapy.
•arm D never used systemic treatment
•Barcelona Clinic Liver Cancer (BCLC) (appendix I) stage C;BCLC stage B patients who are not suitable for locoregional therapy may also be enrolled.
•At least one measurable lesion assessed by IRRC according to RECIST v1.1 (appendix ii) has not been treated locally for this lesion (e.g., radiotherapy, radiofrequency ablation, TACE, ultrasound focusing knife, etc.).
•The end of previous systematic treatment must be ≥ 2 weeks after the first medication in this study, and the treatment-related AE should be restored to the level of ci -CTCAE ≤ 1 (except hair loss).
•Child-pugh liver function rating within 7 days before the first administration of the study drug (appendix iii) : grade A and good grade B (≤ 7 points).

Exclusion Criteria

•Subjects who meet any of the following criteria are not allowed to be enrolled in this study:
•Hepatobiliary duct cell carcinoma, mixed cell carcinoma, or fibroblastic layer cell carcinoma are known.
•Other active malignancies within 5 years prior to the first administration of the study drug.Curable localized tumors, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder carcinoma, carcinoma in situ of the prostate, cervical carcinoma in situ, and carcinoma in situ of the breast, can be included in the group.
•People who are ready to undergo or have received organ or bone marrow transplants.
•After appropriate intervention, uncontrollable pleural effusion, pericardial effusion or ascites still need to be drained frequently (once a month or more frequently).
•Symptomatic, untreated, or progressive central nervous system (CNS) or meningeal metastasis.Asymptomatic subjects treated for CNS lesions can be enrolled if all of the following criteria are met:
•in addition to CNS, there must be lesions that can be measured according to RECIST v1.1;
•the patient had no history of intracranial or spinal bleeding;
•metastatic lesions were limited to cerebellum or supratentorial areas (i.e., no mesencephalon, pons, medulla or spinal cord metastatic lesions);
•there was no evidence of progress between the completion of CNS oriented therapy and the start of research and treatment;

Arms & Interventions

HLX10

HLX10 3mg/kg, as second-line treatment or above

Intervention: HLX10 3mg/kg

HLX10+HLX04 1L treatment

HLX10 3 mg/kg + HLX04 10 mg/kg: as first-line treatment

Intervention: HLX10 3mg/kg

HLX10+HLX04 1L treatment

HLX10 3 mg/kg + HLX04 10 mg/kg: as first-line treatment

Intervention: HLX04 10mg/kg

HLX10 3 mg/kg + HLX04 5 mg/kg

HLX10 3 mg/kg + HLX04 5 mg/kg, as second-line treatment or above

Intervention: HLX10 3mg/kg

HLX10 3 mg/kg + HLX04 5 mg/kg

HLX10 3 mg/kg + HLX04 5 mg/kg, as second-line treatment or above

Intervention: HLX04 5mg/kg

HLX10 3 mg/kg + HLX04 10 mg/kg

HLX10 3 mg/kg + HLX04 10 mg/kg,as second-line treatment or above

Intervention: HLX10 3mg/kg

HLX10 3 mg/kg + HLX04 10 mg/kg

HLX10 3 mg/kg + HLX04 10 mg/kg,as second-line treatment or above

Intervention: HLX04 10mg/kg

Outcomes

Primary Outcomes

ORR

Time Frame: up to 2 years

Objective response rate(assessed by independent radiological review

Secondary Outcomes

PFS(from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 2 years)
ORR(up to 2 years)
12-month PFS rate(the proportion of subjects who have time interval over 12 months between the first dose and disease progression or death)
DOR(from the date when CR or PR (whichever recorded earlier) is firstly achieved until the date when disease progression or death is firstly recorded (whichever occurs earlier),assessed up to 2 years)
12-month OS rate(from the date of first dose unitl the date of 12-month)
OS(from the date of first dose unitl the date of death from any cause，assessed up to 2 years)