TACE Combined With Sorafenib and Tislelizumab for Advanced HCC

NCT04599777 | Completed Phase 2

• 1 other identifier: MIIR-03
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

This study will evaluate the efficacy and safety of transcatheter arterial chemoembolization (TACE) combined with sorafenib and tislelizumab in patients with advanced hepatocellullar carcinoma (HCC).

Conditions

Hepatocellular Carcinoma Non-resectable

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  The time from initiation of treatment until the date of death from any cause.

  24 months

Secondary Outcomes (9)

• Adverse Events (AEs)

  24 months

• Progression free survival (PFS) assessed by investigators according to Response Evalutaion Criteria in Solid Tumors (RECIST) v1.1 and immune-related RECIST (irRECIST).

  24 months

• Objective response rate (ORR) assessed by investigators according to RECIST 1.1 and irRECIST.

  24 months

• Disease control rate (DCR) assessed by investigators according to RECIST 1.1 and irRECIST.

  24 months

• Duration of response (DOR) assessed by investigators according to RECIST 1.1 and irRECIST.

  24 months

Study Arms (1)

TACE-Sor-Tis

EXPERIMENTAL

TACE combined with sorafenib and tislelizumab.

Drug: TACE combined with sorafenib and tislelizumab

Interventions

TACE combined with sorafenib and tislelizumab DRUG

Sorafenib (400mg P.O. Bid) and tislelizumab (200mg I.V. q3w) will be started at 3-7 days after the first TACE. TACE will be repeated if clinically indicated. Treatment of tislelizumab will last up to 24 months. Patients will be allowed to have sorafenib or tislelizumab as a sigle agent and will be still considered on study when the other drug cause intolerable toxicity.

TACE-Sor-Tis

Eligibility Criteria

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

You may qualify if:

• Advanced HCC (BCLC stage C, or CNLC IIIa and IIIb ) with diagnosis confirmed by histology/cytology or clinically
• Disease not amenable to curative therapies but amenable to TACE
• At least one measurable untreated lesion
• No prior systemic therapy for HCC
• Child-Pugh score 5-7
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment
• Adequate organ and hematologic function
• Life expectancy of at least 3 months
• For women of childbearing potential and for men: agreement to remain abstinent

You may not qualify if:

• Diagnosis of fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
• Diffuse HCC
• Portal vein tumor thrombus (PVTT) involves the main trunk and contralateral branch or upper mesenteric vein
• Inferior vena cava tumor thrombus
• Metastatic disease that involves major airways or blood vessels
• Symptomatic, untreated or progressing central nervous system metastasis
• Uncontrolled tumor-related pain
• Patients who received prior systemic therapy, immunotherapy, TACE, transcatheter arterial radioembolization (TARE), transcatheter arterial embolization (TAE), hepatic arterial infusion chemotherapy (HAIC) or radiation therapy for HCC
• Treatment with systemic immunostimulatory agents
• Use of herbal therapies or traditional Chinese medicines with anti-cancer activity within 2 weeks
• History of malignancy other than HCC within 5 years prior to screening, except for malignancies with a negligible risk of metastasis or death
• Uncontrolled ascites, hydrothorax or pericardial effusion
• Prior esophageal and/or gastric varices bleeding within 6 months prior to initiation of study treatment
• Prior life-threatening blood loss or grade 3/4 gastrointestinal bleeding requiring blood infusion, endoscopic or surgical intervention within 3 months
• Untreated or incompletely treated esophageal and/or gastric varices with bleeding or high-risk for bleeding

Sponsors & Collaborators

• Second Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (2)

The 2nd Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510260, China

Location

the Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510260, China

Location

MeSH Terms

Interventions

Sorafenib; tislelizumab

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Kangshun Zhu, Dr.

  Second Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: October 23, 2020
• Study Start: October 1, 2020
• Primary Completion: October 11, 2022
• Study Completion: October 11, 2022
• Last Updated: October 13, 2022

Record last verified: 2022-02

Locations

CN (2)