Actively Recruiting
Triple Therapy Sequential Radiotherapy in Unresectable HCC (TALENP003)
Led by Fujian Provincial Hospital · Updated on 2024-08-20
28
Participants Needed
4
Research Sites
202 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an Open-label, Multicenter, Phase II clinical trial to evaluate the efficacy and safety of Transcatheter arterial chemoembolization (TACE), Lenvatinib combination with Sintilimab (Triple Therapy) sequential radiotherapy in patients with Unresectable Hepatocellular Carcinoma (uHCC).
CONDITIONS
Official Title
Triple Therapy Sequential Radiotherapy in Unresectable HCC (TALENP003)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to enroll and sign informed consent
- Age between 18 and 75 years, male or female
- Child-Pugh class A liver function
- Indocyanine green 15 min retention rate less than 15%
- ECOG performance status 0-1
- Diagnosed with hepatocellular carcinoma according to Chinese HCC Guidelines 2022 with expected survival over 4 months
- Initial unresectable HCC (BCLC stage B or C), showing partial response or stable disease after 2 months of TACE, Lenvatinib, and Sintilimab treatment
- 1 to 3 residual active liver lesions suitable for radiation therapy
- Normal tissue radiation dose limits according to UK Consensus
- No prior tumor-related targeted, immunotherapy, radiotherapy, or chemotherapy treatments
- At least one measurable lesion per RECIST 1.1 (diameter ≥10 mm) not previously treated locally
- Adequate blood counts: neutrophils ≥1.5×10^9/L, hemoglobin ≥8.5 g/L, platelets ≥75×10^9/L
- No severe cardiac arrhythmia or heart failure; no severe lung disease or infection; creatinine clearance >40 mL/min
- Women of childbearing age must use contraception during and 6 months after treatment and have a negative pregnancy test within 7 days prior to enrollment; men must also agree to contraception during and 6 months after the study
You will not qualify if you...
- Complete response or progressive disease after 2 months of TACE, Lenvatinib, and Sintilimab treatment
- Tumor with cancerous thrombus in inferior vena cava and extrahepatic metastasis
- Prior antitumor therapies before study entry including targeted drugs, PD-1/PD-L1 inhibitors, surgery, TACE, radiotherapy, chemotherapy, or locus coeruleus granule drugs
- Allergy to Lenvatinib, Sintilimab, or their components
- Tumor volume two-thirds or more of liver or diffuse intrahepatic lesions
- Active autoimmune disease or expected relapse of autoimmune conditions requiring treatment
- History of immunodeficiency or recent immunosuppressive or systemic hormone therapy
- Known bleeding or clotting disorders or recent use of full-dose anticoagulants or thrombolytics
- Severe infections or signs of active infection requiring antibiotics within specified timeframes
- Significant proteinuria (≥1 g/24 hours)
- History of other malignant tumors within 5 years except certain cured cancers
- Co-morbid mental illness or history of substance abuse
- Pregnant or breastfeeding women
- Contraindications to surgery such as renal or cardiopulmonary insufficiency or other reasons judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Not Yet Recruiting
2
Fujian Provincial Hospital
Fuzhou, Fujian, China
Actively Recruiting
3
Fujian provincial hospital
Fuzhou, Fujian, China
Not Yet Recruiting
4
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, China
Not Yet Recruiting
Research Team
S
Shao-Ming Wei
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
1
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