A Phase 2, Multi-Center, Single Arm Study to Evaluate Lenvatinib Plus Tislelizumab for Locally Advanced Unresectable or Metastatic Hepatocellular Carcinoma With Hepatitis B Virus Infection and Biomarker Analyses

Fujian Cancer Hospital0 sites30 target enrollmentAugust 1, 2023

ConditionsHepatocellular Carcinoma

InterventionsLenvatinib at a dose of 8 mg or 12 mg based on body weight + tislelizumab for one 21-day cycle

DrugsLenvatinib at a dose of 8 mg or 12 mg based on body weight + tislelizumab for one 21-day cycle

Overview

Phase: Phase 2
Intervention: Lenvatinib at a dose of 8 mg or 12 mg based on body weight + tislelizumab for one 21-day cycle
Conditions: Hepatocellular Carcinoma
Sponsor: Fujian Cancer Hospital
Enrollment: 30
Primary Endpoint: Objective response rate (ORR)
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study is to investigate the efficacy and safety of Lenvatinib Plus Tislelizumab for Locally Advanced Unresectable or Metastatic Hepatocellular Carcinoma With Hepatitis B Virus Infection and Biomarker Analyses.

Detailed Description

Registry

clinicaltrials.gov

Start Date

August 1, 2023

End Date

June 1, 2027

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Fujian Cancer Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Signed written informed consent before screening;
•Age ≤ 18 years old ≤75 years old for both men and women;
•ECOG score 0-1;
•A clinical or pathological diagnosis of hepatocellular carcinoma should meet one of the following criteria: ① A histological or cytological diagnosis of hepatocellular carcinoma, except for fibrolamellar, sarcomatoid or mixed cholangiocarcinoma; ② According to the Diagnosis and Treatment Guidelines for Primary Liver Cancer (2022 Edition), the patient was clinically diagnosed with HCC;
•Hepatitis B virus surface antigen (HBsAg) positive and hepatitis B virus (HBV) DNA\<2000IU/ml or 104 copies /ml; Or hepatitis B virus core antibody (HBcAb) positive, HBsAg negative, and highly sensitive HBV DNA\<2000IU/ml or 104 copies /ml;
•have not previously received any systemic therapy for HCC (mainly including systemic chemotherapy, antivascular therapy, molecular targeted therapy, immunotherapy targeting any other antibodies or drugs that act on T-cell co-stimulation or immune checkpoint pathways, Including but not limited to anti-PD-1, anti-PD-L1 /L2, anti-CD137 or anti-ctLA-4 antibodies), and disease progression 6 months after the end of postoperative adjuvant chemotherapy were allowed to be enrolled;
•Chinese clinical stage of liver cancer (CNLC) Ⅲb or CNLC Ⅱb-Ⅲa which is not suitable for surgery and/or local treatment;
•Child-Pugh rating for liver function: Grade A and good Grade B (≤7 points), and no history of hepatic encephalopathy;
•There is at least one measurable lesion according to the efficacy evaluation criteria for solid tumors (RECIST version 1.1), and there is definite disease progression for lesions previously treated locally
•Can be selected as a target lesion;

Exclusion Criteria

•Liver surgery and/or local treatment for HCC, except palliative radiotherapy for bone metastases to relieve pain, had been performed within 4 weeks prior to initial study drug therapy;
•Subjects (except hair loss and fatigue) who have not recovered from any toxicity and/or complications of local therapy (including interventional therapy, radio frequency therapy, etc.), previous chemotherapy, surgery, radiotherapy, that is, have not fallen to ≤ Grade 1 (NCI CTCAE version 5.0);
•Have received anti-tumor drug therapy in the past (including but not limited to traditional Chinese medicine preparations with anti-tumor indications);
•With moderate or severe ascites or ascites requiring drainage, or with pleural or pericardial effusion requiring drainage and/or symptoms of shortness of breath;
•with known active central nervous system metastases (CNS) and/or cancerous meningitis;
•With other malignancies (other than cured cervical carcinoma in situ, non-melanoma skin cancer or other tumors/cancers that have been treated radically and have shown no signs of disease for at least 5 years);
•(7) Combined history of bleeding tendency, high risk of bleeding, or cocoagulation dysfunction, including an arteriovenous thromboembolism event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, pulmonary embolism, deep vein thrombosis, or any other severe thromboembolism in the 6 months prior to screening;
•The portal vein cancer thrombus involved the main trunk, or both the main trunk and the superior mesenteric vein, or the inferior vena cava cancer thrombus or heart involvement;
•Unhealed wounds, active digestive tract ulcers or bleeding, fractures (excluding healed old fractures);
•Esophageal or gastric varicose bleeding occurred within 6 months prior to treatment, or severe varicose veins were known to exist on endoscopic examination.

Arms & Interventions

Lenvatinib plus Tislelizumab

Intervention: Lenvatinib at a dose of 8 mg or 12 mg based on body weight + tislelizumab for one 21-day cycle

Outcomes

Primary Outcomes

Objective response rate (ORR)

Time Frame: 12 months

the proportion of participants who got a complete response (CR) and partial response (PR) according to RECIST v1.1.

Secondary Outcomes

Incidence of Treatment-Emergent Adverse Events(from first dose to within 30 days after the last dose)
Duration of response (DOR)(time from CR or PR (RECIST v1.1) achievement with investigational therapy, until documented progression, relapse, or death due to disease progression)
Disease Control Rate (DCR)(12 months)
Progression-Free Survival (PFS)(From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months)
Overall survival(OS)(From date of treatment until the date of death from any cause, whichever came first, assessed up to 100 months)