Hepatocellular Carcinoma (HCC)Phase 3NCT07186621
Adjuvant Radiotherapy of Sintilimab Versus TACE for HCC
A Phase 3 study testing Sintilimab, radiotherapy and TACE in people with Hepatocellular Carcinoma (HCC) and Radiotherapy, Adjuvant, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This study is an open-label, randomized controlled, multicenter, phase III clinical trial Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma (HCC), Radiotherapy, Adjuvant, Immune Checkpoint Inhibitor
- What is being tested?
- Sintilimab, radiotherapy and TACE
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2025to 30 Nov 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- R0 resection of hepatocellular carcinoma (HCC) with a surgical margin <1 cm (determined by postoperative pathology, surgical records, and imaging).
- Within 4 months after curative resection.
- High-Risk Recurrence Factors (at least one required in addition to narrow margin): (1) Microvascular invasion (MVI) positive, tumor thrombus, or satellite nodules (2) Preoperative AFP >400 ng/mL (3) Tumor >5 cm with incomplete capsule
- ≥18 and ≤80 years old.
- ECOG score 0-1.
- Child-Pugh Class: A5, A6, or B7.
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- Postoperative Contrast-enhanced MRI of the liver must be performed to exclude intrahepatic residual lesions.
- HBV DNA and HCV RNA status do not affect eligibility, but if HBV DNA positive and/or HCV RNA positive: ALT must be <1.5× upper limit of normal (ULN). Antiviral therapy must be initiated.
- Liver Function Tests (LFTs): ALT ≤2.5× ULN (if HBV/HCV positive, ALT ≤1.5× ULN). If ALT ≤1.5× ULN, AST ≤6× ULN (excluding AST elevation due to myocardial infarction). If ALT 1.5-2.5× ULN, AST ≤2.5× ULN.
- No significant ECG abnormalities and no severe cardiac dysfunction.
- Serum creatinine (CRE) and BUN ≤2.5× ULN.
- Hb≥80g/L，ANC≥1.0×109 /L，PLT≥40×109 /L.
- Written informed consent obtained.
Who cannot join
- Vp3 or Vp4 portal vein tumor thrombus (PVTT) or Vv2/Vv3 inferior vena cava (IVC) tumor thrombus on preoperative imaging.
- Previous anti-HCC therapies, including but not limited to: targeted therapy (e.g., tyrosine kinase inhibitors), immune checkpoint inhibitors (e.g., PD-1/PD-L1 inhibitors) or systemic chemotherapy
- Distant metastasis before randomization.
- Moderate to severe ascites unresponsive to medical management.
- History of other malignancies, except: carcinoma in situ，early-stage papillary thyroid cancer or basal cell carcinoma of the skin
- Previous radiotherapy involving the abdomen.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing
Bo Chen, MD, 00861324000876, chenboo@outlook.com
About this study
Official title: 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
This study is an open-label, randomized controlled, multicenter, phase III clinical trial
Read the detailed description
This study is an open-label, randomized controlled, multicenter, phase III clinical trial where participants are randomized in a 1:1 ratio to either the experimental or control group. The experimental group will initiate radiotherapy within 4 months postoperatively with prescribed doses of 44-50Gy in 22-25 fractions to the tumor bed and 56-60Gy in 22-25 fractions to narrow-margin areas adjacent to major blood vessels, along with concurrent sintilimab 200mg q3w for 2 cycles followed by maintenance sintilimab 200mg q3w for 15 cycles (approximately 1 year total treatment duration) until disease progression or unacceptable toxicity. The control group will receive the first TACE procedure within 4 months postoperatively, with the decision on administering a second TACE to be determined by the investigator based on the patient's condition and first TACE response assessment. The primary endpoint is 2-year recurrence-free survival (RFS) rate, while secondary endpoints include 2-year overall survival (OS) rate and incidence of adverse events.
- Conditions
- Hepatocellular Carcinoma (HCC), Radiotherapy, Adjuvant, Immune Checkpoint Inhibitor, TACE, Narrow Margin
- Being tested
- Sintilimab, radiotherapy, TACE
- Keywords
- hepatocellular carcinoma, radiotherapy, narrow margin, sintilimab, TACE
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SintilimabDrug
concurrent sintilimab 200mg q3w for 2 cycles followed by maintenance sintilimab 200mg q3w for 15 cycles (approximately 1 year total treatment duration) until disease progression or unacceptable toxicity
radiotherapyRadiation
The experimental group will initiate radiotherapy within 4 months postoperatively with prescribed doses of 44-50Gy in 22-25 fractions to the tumor bed and 56-60Gy in 22-25 fractions to narrow-margin areas adjacent to major blood vessels
TACEProcedure or surgery
The control group will receive the first TACE procedure within 4 months postoperatively, with the decision on administering a second TACE to be determined by the investigator based on the patient's condition and first TACE response assessment.
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | The control group will receive the first TACE procedure within 4 months postoperatively, with the decision on administering a second TACE to be determined by the investigator based on the patient's condition and first TACE response assessment. Receives: Procedure: TACE |
| experiment group | Experimental | The experimental group will initiate radiotherapy within 4 months postoperatively with prescribed doses of 44-50Gy in 22-25 fractions to the tumor bed and 56-60Gy in 22-25 fractions to narrow-margin areas adjacent to major blood vessels, along with concurrent sintilimab 200mg q3w for 2 cycles followed by maintenance sintilimab 200mg q3w for 15 cycles (approximately 1 year total treatment duration) until disease progression or unacceptable toxicity. Receives: Drug: Sintilimab; Radiation: radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year RFS
the percentage of patients who remain free of detectable cancer recurrence (local, regional, or distant) and alive for at least 2 years after randomization
Measured: 2-year after randomization
Secondary outcomes (2)
2-year OS
the percentage of patients who are still alive (from any cause) at 2 years after randomization
Measured: 2-year after randomization
adverse events
any symptoms, signs, and laboratory examinations abnormality during the clinical trial
Measured: up to 2 years after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start10 Jul 2025
- Primary completion9 Jul 2027 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 286 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University People's Hospital, Nanfang Hospital, Southern Medical University, Beijing 302 Hospital, Beijing Ditan Hospital, Eastern Hepatobiliary Surgery Hospital
- Responsible party
- Sponsor
- Investigators
- Shuhang Wang, Study director, NCC, CICAMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07186621
- Sponsor's protocol ID
- NCC5448
- Status last verified
- Jul 2025
- First submitted
- 16 Sep 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No