Actively Recruiting
Adjuvant Radiotherapy Combined With Sintilimab Versus Transarterial Chemoembolization (TACE) for Hepatocellular Carcinoma With Narrow Margins and High-Risk Features Following Resection: A Multi-center Phase III Randomized Controlled Trial
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2025-09-22
286
Participants Needed
1
Research Sites
72 weeks
Total Duration
On this page
Sponsors
C
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Lead Sponsor
P
Peking University People's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting a phase III, open-label, randomized controlled trial to compare two treatments after surgery for hepatocellular carcinoma (HCC) with narrow surgical margins and high-risk features. The goal is to assess which approach better prevents cancer recurrence and improves survival over a two-year period. This multicenter study evaluates adjuvant radiotherapy combined with the drug sintilimab against transarterial chemoembolization (TACE).
CONDITIONS
Brief Title
Adjuvant Radiotherapy of Sintilimab Versus TACE for HCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- R0 resection of hepatocellular carcinoma with a surgical margin less than 1 cm
- Within 4 months after curative resection
- At least one high-risk recurrence factor: positive microvascular invasion, tumor thrombus, satellite nodules, preoperative AFP over 400 ng/mL, or tumor larger than 5 cm with incomplete capsule
- Age between 18 and 80 years
- ECOG performance status 0-1
- Child-Pugh Class A5, A6, or B7
- Postoperative contrast-enhanced MRI excluding intrahepatic residual lesions
- If HBV DNA or HCV RNA positive, ALT less than 1.5 times upper limit of normal and antiviral therapy initiated
- Liver function tests within specified limits (ALT, AST levels)
- No significant ECG abnormalities or severe cardiac dysfunction
- Serum creatinine and BUN within 2.5 times upper limit of normal
- Hemoglobin above 80 g/L, ANC at least 1.0x10^9/L, platelets at least 40x10^9/L
- Written informed consent obtained
You will not qualify if you...
- Vp3 or Vp4 portal vein tumor thrombus or Vv2/Vv3 inferior vena cava tumor thrombus on preoperative imaging
- Previous anti-HCC therapies including targeted therapy, immune checkpoint inhibitors, or chemotherapy
- Distant metastasis before randomization
- Moderate to severe ascites unresponsive to treatment
- History of other malignancies except carcinoma in situ, early-stage papillary thyroid cancer, or basal cell carcinoma of the skin
- Previous abdominal radiotherapy
- Significant cardiac, renal, or other major organ dysfunction
- Active autoimmune disease or psychiatric disorders
- HIV infection
- Pregnant or breastfeeding women
- Currently enrolled in another interventional clinical trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 1 year or until disease progression or unacceptable toxicity
Participants receive either radiotherapy combined with sintilimab or transarterial chemoembolization (TACE) following surgery.
Radiotherapy delivered in 22-25 fractions; concurrent sintilimab given every 3 weeks for 2 cycles followed by maintenance every 3 weeks for 15 cycles; TACE procedures within 4 months postoperatively with possible second TACE based on condition
Duration - Up to 2 years after randomization
Participants are monitored for recurrence, survival, and adverse events after completion of treatment.
Regular visits for assessments up to 2 years
Trial Site Locations
Total: 1 location
1
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, China
Actively Recruiting
Research Team
B
Bo Chen, MD.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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