TACE Combined With Sintilimab and Bevacizumab for Unresectable HCC

NCT04592029 | Unknown Phase 1

• 1 other identifier: MIIR-02
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to evaluate the safety and efficacy of transcatheter arterial chemoembolization (TACE) combined with sintilimab and bevacizumab in patients with unresectable intermediate or advanced hepatocellular carcinoma (HCC).

Conditions

Hepatocellular Carcinoma Non-resectable

Outcome Measures

Primary Outcomes (2)

• Adverse Events (AEs)

  Number of patients with AE, treatment-related AE (TRAE), immune-related AE (irAE), AE of special interest (AESI), serious adverse event (SAE), assessed by NCI CTCAE v5.0.

  24 months

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

  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 (8)

• Overall survival (OS)

  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

• PFS assessed by investigators according to Modified RECIST (mRECIST).

  24 months

Study Arms (1)

TACE-Sin-Bev

EXPERIMENTAL

TACE combined with sintilimab and bevacizumab.

Drug: TACE combined with sintilimab and bevacizumab

Interventions

TACE combined with sintilimab and bevacizumab DRUG

Sintilimab and bevacizumab are administered at 3-7 days after the first TACE. The study includes dose escalation and dose expansion stage. 6-9 subjects will be enrolled in dose escalation stage for the safety and efficacy evaluation. Then, Sintilimab 200mg/kg IV. q3w+ select specific dose of bevacizumab (7.5mg/kg or 15 mg/kg IV. q3w), expand to 36-39 patients for the further safety and efficacy study. The study treatment of sintilimab and bevacizumab lasts up to 24 months. TACE can be repeated when indicated clinically.

TACE-Sin-Bev

Eligibility Criteria

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

You may qualify if:

• Intermediate or advanced (Barcelona Clinic Liver Cancer stage B or C) HCC 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 class 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

MeSH Terms

Interventions

sintilimab; Bevacizumab

Intervention Hierarchy (Ancestors)

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

Study Officials

• Kangshun Zhu, Dr.

  Second Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: October 19, 2020
• Study Start: September 27, 2020
• Primary Completion: June 30, 2022
• Study Completion: December 31, 2022
• Last Updated: September 23, 2021

Record last verified: 2021-09

Locations

CN (1)