TACE Combined With Lenvatinib and Sintilimab for Advanced HCC

NCT04599790 | Completed Phase 2

• 1 other identifier: MIIR-04
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hepatocellular Carcinoma Non-resectable

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS) assessed by investigators according to Modified RECIST (mRECIST)

  The time from initiation of treatment until the first occurrence of disease progression or death from any cause, whichever occurs first.

  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-Len-Sin

EXPERIMENTAL

TACE combined with lenvatinib and sintilimab.

Drug: TACE combined with lenvatinib and sintilimab

Interventions

TACE combined with lenvatinib and sintilimab DRUG

Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight \<60kg) P.O. qd and sintilimab 200mg I.V. q3w will be started at 3-7 days after the first TACE.TACE will be repeated if clinically indicated. Treatment of sintilimab will last up to 24 months. Patients will be allowed to have lenvatilib or sintilimab as a sigle agent and will be still considered on study when the other drug cause intolerable toxicity.

TACE-Len-Sin

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 (1)

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510260, China

Location

Related Publications (1)

• Cai M, Huang W, Liang W, Guo Y, Liang L, Lin L, Xie L, Zhou J, Chen Y, Cao B, Wu J, Zhu K. Lenvatinib, sintilimab plus transarterial chemoembolization for advanced stage hepatocellular carcinoma: A phase II study. Liver Int. 2024 Apr;44(4):920-930. doi: 10.1111/liv.15831. Epub 2024 Jan 30.

  PMID: 38291865 DERIVED

MeSH Terms

Interventions

lenvatinib; sintilimab

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: November 29, 2021
• Study Completion: October 31, 2022
• Last Updated: November 10, 2022

Record last verified: 2022-02

Locations

CN (1)