Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04599777
Other study ID # MIIR-03
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date October 1, 2020
Est. completion date October 11, 2022

Study information

Verified date February 2022
Source Second Affiliated Hospital of Guangzhou Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Description:

This is a Phase II study to evaluate the efficacy and safety of TACE combined with sorafenib and tislelizumab in patients with advanced HCC. 30 subjects with advanced HCC (Barcelona-Clinic- Liver-Cancer [BCLC] stage C, or China liver cancer staging [CNLC] IIIa and IIIb) will be enrolled in the study. Both 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 based on the evaluation of follow-up laboratory and imaging examination. Sorafenib will last until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. Sorafenib administration will be delayed in cases of grade ≥2 hand-foot syndrome, grade >3 hematologic toxicities or grade ≥3 hypertension. After recovery, sorafenib will be reintroduced at a reduced dose according the sorafenib dose delay and reduction guidelines. Treatment of tislelizumab will last up to 24 months, or until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date October 11, 2022
Est. primary completion date October 11, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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 - History of gastrointestinal (GI) perforation and/or fistula in the past 6 months history of GI obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection, complicated by chronic diarrhea), Crohn's disease, ulcerative colitis or long-term chronic diarrhea - History of hepatic encephalopathy - History of organ and stem cell transplantation - Long-term daily treatment with a non-steroidal anti-inflammatory drug (NSAID) - Use of immunosuppressive drugs in the past 4 weeks, excluding the routes of topical glucocorticoids or physiological doses of systemic glucocorticoids (ie no more than 10 mg/day of prednisone or equivalent). Temporary use of glucocorticoids for dyspnea symptoms such as asthma and chronic obstructive pulmonary disease is allowed - History of idiopathic pulmonary fibrosis, interstitial pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis - Active tuberculosis - Active severe infection; use of antibiotics within 2 weeks prior to injection of tislelizumab - Autoimmune disease or immune deficiency - Inadequately controlled hypertension; history of hypertensive crisis or hypertensive encephalopathy - Bleeding diathesis or significant coagulopathy - Serious, non-healing or dehiscing wound, active ulcer, or untreated bone fracture underwent major surgery (craniotomy, thoracotomy or open surgery) within 4 weeks; non-recovery from side effects of these procedure - History of venous thromboembolism in the past 6 months, but implantable IV ports or catheter-derived thrombosis, superficial venous thrombosis, or thrombosis after conventional anticoagulant therapy are excluded - Current or recent use of aspirin or treatment with dipyramidole, ticlopidine, clopidogrel, or cilostazol uncontrolled metabolic disorder, non-malignant organ or systemic disease or secondary carcinomatous reaction, with high medical risk and/or uncertainty of life expectancy evaluation - Other acute or chronic diseases, mental illness, or abnormal laboratory test results that may lead to the following outcomes: increase the risk of participating in study or study drug administration, or interfere with the interpretation of the study results and considered by investigator as "NOT" eligible to participate in this study - Female patients who are pregnancy or breastfeeding

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
TACE combined with sorafenib and tislelizumab
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.

Locations

Country Name City State
China The 2nd Affiliated Hospital of Guangzhou Medical University Guangzhou Guangdong
China the Second Affiliated Hospital of Guangzhou Medical University Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Second Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall survival (OS) The time from initiation of treatment until the date of death from any cause. 24 months
Secondary 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
Secondary Progression free survival (PFS) assessed by investigators according to Response Evalutaion 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 Objective response rate (ORR) assessed by investigators according to RECIST 1.1 and irRECIST. The percentage of patients who had a best overall tumor response rating of complete response (CR) or partial response (PR). 24 months
Secondary Disease control rate (DCR) assessed by investigators according to RECIST 1.1 and irRECIST. The percentage of patients who had a tumor response rating of CR, PR, or stable disease (SD). 24 months
Secondary Duration of response (DOR) assessed by investigators according to RECIST 1.1 and irRECIST. The time from the first occurrence of a documented objective response to disease progression (PD) or death. 24 months
Secondary 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 ORR assessed by investigators according to mRECIST. The percentage of patients who had a best overall tumor response rating of CR or PR. 24 months
Secondary DCR assessed by investigators according to mRECIST. The percentage of patients who had a tumor response rating of CR, PR, or SD. 24 months
Secondary DOR assessed by investigators according to mRECIST. The time from the first occurrence of a documented objective response to PD or death. 24 months
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04592029 - TACE Combined With Sintilimab and Bevacizumab for Unresectable HCC Phase 1
Recruiting NCT05953337 - Radioembolization Trial Utilizing Eye90 Microspheres™ for the Treatment of Hepatocellular Carcinoma (HCC) N/A
Not yet recruiting NCT03283956 - Safety and Efficacy of dRug-ElutiNg beADs Trans-arterial chemoEmbolization for Hepatocellular Carcinoma in Taiwan N/A
Recruiting NCT03652467 - The Safety and Efficacy of Deferoxamine for Treating Unresectable Hepatocellular Carcinoma Phase 1
Recruiting NCT05031949 - Hyperbaric Oxygen Therapy Combined Camrelizumab in Patients With Advanced/Metastatic Hepatocellular Carcinoma Phase 1
Completed NCT03533920 - Clinical Trial to Evaluate the Efficacy and Safety of UNI-DEB for Unresectable Hepatocellular Carcinoma N/A
Recruiting NCT05992220 - Atezolizumab Plus Bevacizumab Alone or Combined With External Beam Radiotherapy for HCC With Macrovascular Invasion Phase 2
Not yet recruiting NCT05057104 - Non-inferiority Study of Unresectable Hepatocelluar Carcinoma Receiving Stereotactic Radiotherapy Combined With Hepatic Arterial Chemoembolization Compared With Conversion Hepatectomy
Completed NCT04599790 - TACE Combined With Lenvatinib and Sintilimab for Advanced HCC Phase 2
Recruiting NCT02967887 - Evaluation of Hepatic Arterial Infusion of Cisplatin and 5-FU in Biomarker Stratified HCC Phase 2
Recruiting NCT05608200 - Lenvatinib+Sintilimab+TACE vs. Lenvatinib+TACE for Advanced HCC Phase 3
Recruiting NCT05608213 - Lenvatinib Plus I-125 Seed Brachytherapy vs. Lenvatinib for TACE-refractory HCC Phase 3
Completed NCT04926376 - Safety and Effectiveness of Eye90 Microspheres™ in the Treatment of Unresectable HCC and mCRC N/A
Recruiting NCT06133062 - Atezolizumab and Bevacizumab With Proton Radiotherapy for Unresectable Hepatocellular Carcinoma Phase 2
Completed NCT02989922 - A Study to Evaluate SHR-1210 in Subjects With Advanced HCC Phase 2
Recruiting NCT04273100 - PD-1 Monoclonal Antibody, Lenvatinib and TACE in the Treatment of HCC Phase 2
Completed NCT06408753 - Plasma Biomarker in Predicting Response and Toxicity in HCC Patients Treated With Checkpoint Inhibitors With or Without SBRT
Withdrawn NCT03563170 - QUILT-3.072: NANT Hepatocellular Carcinoma (HCC) Vaccine Phase 1/Phase 2
Recruiting NCT05390112 - Cohort Study of Patients With Hepatocellular Carcinoma and Circulating Tumor DNA Monitoring of Chemoembolization
Recruiting NCT05713994 - Combined HAIC, TKI/Anti-VEGF and ICIs as Conversion Therapy for Unresectable Hepatocellular Carcinoma