Actively Recruiting
TACE and SBRT Followed by Double Immunotherapy for Downstaging Hepatocellular Carcinoma
Led by The University of Hong Kong · Updated on 2023-09-06
33
Participants Needed
2
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a prospective phase II, single arm mono-institutional study conducted in Queen Mary Hospital (Hong Kong) assessing the efficacy and safety of the sequential administration of trans-arterial chemo-embolization (TACE) and stereotactic body radiotherapy (SBRT) with immune checkpoint inhibitors in unresectable hepatocellular carcinoma (HCC) patients.
CONDITIONS
Official Title
TACE and SBRT Followed by Double Immunotherapy for Downstaging Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give signed informed consent and comply with study requirements
- Diagnosis of unresectable hepatocellular carcinoma confirmed by pathology or specific imaging criteria
- Male or female aged over 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Body weight greater than 30 kg
- For women: post-menopausal status or negative pregnancy test with specific criteria based on age
- Life expectancy of at least 12 weeks
- Willingness and ability to comply with study protocol and visits
- Tumor size between 5 and 25 cm with up to 3 lesions
- Portal vein involvement allowed up to Vp3
- Liver volume minus tumor volume greater than 700 cc
- Child-Pugh liver function class A to B7
- No prior immunotherapy
- Patients with hepatitis B treated with antiviral therapy and viral suppression
- At least one measurable lesion per RECIST v1.1
- Adequate blood counts and organ function based on specified laboratory values
You will not qualify if you...
- Participation in another investigational study within 4 weeks prior to treatment
- Concurrent enrollment in another interventional clinical study
- Unresolved toxicity grade 2 or higher from previous cancer therapy (except certain conditions)
- Concurrent chemotherapy, investigational products, biologic, or hormonal cancer treatments
- Prior liver radiotherapy or selective internal radiotherapy
- Major surgery within 28 days prior to treatment
- History of primary immunodeficiency or organ transplantation
- Active or prior autoimmune or inflammatory disorders with exceptions
- Uncontrolled illness including active infections or serious chronic conditions
- History of another primary malignancy within 5 years except certain treated cancers
- History or presence of leptomeningeal carcinomatosis or extra-hepatic metastases
- Untreated central nervous system metastases or carcinomatous meningitis
- Active infections including tuberculosis, hepatitis B, hepatitis C, or HIV
- Recent use of immunosuppressive medications except specified exceptions
- Recent live attenuated vaccine within 30 days prior to treatment
- Pregnancy or breastfeeding or unwillingness to use effective birth control
- Known allergy or hypersensitivity to the study drugs or excipients
- Prior participation in durvalumab or tremelimumab studies or prior anti-PD-1/PD-L1/CTLA-4 therapies with certain restrictions
- Contraindications for SBRT such as tumor size over limits, more than 3 hepatic nodules, or direct tumor spread to certain organs
- Main portal vein or inferior vena cava thrombosis
- Clinically significant ascites requiring intervention
- Hepatic encephalopathy
- Active or prior gastrointestinal variceal bleeding
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Department of Surgery, The University of Hong Kong
Hong Kong, Hong Kong
Actively Recruiting
2
The University of Hong Kong
Hong Kong, Hong Kong
Actively Recruiting
Research Team
A
Albert CHAN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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