Actively Recruiting
Combined TACE, TKI/Anti-VEGF and ICIs as Conversion Therapy for Advanced Hepatocellular Carcinoma
Led by Tongji Hospital · Updated on 2024-06-13
300
Participants Needed
4
Research Sites
153 weeks
Total Duration
On this page
Sponsors
T
Tongji Hospital
Lead Sponsor
C
Chinese Cooperative Group of Liver Cancer
Collaborating Sponsor
AI-Summary
What this Trial Is About
The aim of this study is to the efficacy, prognosis, adverse effects, and factors for predicting therapeutic effects and clinical prognosis of combined therapy of transarterial chemoembolization (TACE), Anti-VEGF antibodies or pan-target anti-angiogenic drugs, and anti-PD-1/ PD-L1 antibody for advanced hepatocellular carcinoma which initially unsuitable for the radical therapy, including resection, transplantation, or ablation.
CONDITIONS
Official Title
Combined TACE, TKI/Anti-VEGF and ICIs as Conversion Therapy for Advanced Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of hepatocellular carcinoma based on AASLD or EASL guidelines
- At least one measurable tumor lesion per RECIST v1.1 or mRECIST criteria
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- HCC assessed as unsuitable for radical surgery, liver transplant, or ablation due to reasons such as infeasible R0 resection, insufficient liver remnant volume, or BCLC stage B or C
- Portal vein involvement allowed if within Chen's group A or Cheng's type I-II
- Hepatic vein invasion (VV1 to VV2) allowed
- Extrahepatic oligometastasis allowed with up to three metastatic lesions in two organs, each ≤3 cm
- Child-Pugh liver function class A or B7
- No prior transplantation, TACE, or radioembolization to the liver; prior locoregional therapies allowed if disease progressed and completed at least 4 weeks before baseline
- Adequate organ and marrow function (specified blood counts, liver enzymes, bilirubin, albumin, INR, creatinine)
- Time interval between TACE and systemic therapy within 7 days
You will not qualify if you...
- Prior invasive malignancy within 2 years except certain noninvasive cancers
- Severe, active, uncontrolled comorbidities including infections (except HBV/HCV), heart failure symptoms, uncontrolled diabetes, hypertension (systolic ≥160 mmHg or diastolic ≥100 mmHg within 28 days before first drug dose), unstable angina, arrhythmias, active interstitial lung disease, severe chronic gastrointestinal disease with diarrhea
- Psychiatric or social problems limiting informed consent ability
- History of active primary immunodeficiency or HIV
- Active or prior autoimmune or inflammatory diseases including inflammatory bowel disease, lupus, sarcoidosis, granulomatous vasculitis, rheumatoid arthritis, pituitary inflammation, uveitis
- History of hepatic decompensation such as refractory ascites, gastrointestinal bleeding, or encephalopathy
- Known allergy or hypersensitivity to study drugs or excipients
- Significant gastrointestinal bleeding or bleeding risk within 30 days before study entry
- Central nervous system tumors including metastatic brain tumors
- Pregnant or breastfeeding women
- Prior anti-tumor systemic therapy for HCC; non-anti-tumor hormone therapy excluded
- Current or recent (within 14 days) use of immunosuppressive drugs except certain low-dose or topical steroids
- Live attenuated vaccine within 30 days before first study drug dose
- Extrahepatic vascular involvement or thrombosis of main portal vein trunk, superior mesenteric vein (Cheng's type III and IV), or inferior vena cava (VV3)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
The Second Affiliated Hospital of Fujian Medical University
Quanzhou, Fujian, China
Actively Recruiting
2
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Actively Recruiting
3
Optical Valley branch of Tongji hospital
Wuhan, Hubei, China, 430073
Actively Recruiting
4
Sino-French branch of Tongji hospital
Wuhan, Hubei, China
Actively Recruiting
Research Team
Z
Ze-yang Ding, M.D.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
7
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