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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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
Are there results?
Not yet: the study is under way

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.

Bo Chen, MD. contact

8610-87788245

chenboo@outlook.com

China1 site, 1 recruiting

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    Beijing

    Bo Chen, MD, 00861324000876, chenboo@outlook.com

    Recruiting

Other trials in China

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.

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 groups in NCT07186621
Study groupRoleWhat they receive
control groupActive comparatorThe 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 groupExperimentalThe 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.

  1. 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)

  1. 2-year OS

    the percentage of patients who are still alive (from any cause) at 2 years after randomization

    Measured: 2-year after randomization

  2. 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.

  1. First posted22 Sep 2025
  2. Study start10 Jul 2025
  3. Primary completion9 Jul 2027 (estimated)
  4. Study completion30 Nov 2028 (estimated)

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Bo Chen, MD. (8610-87788245, chenboo@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

2-year RFS (time frame: 2-year after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07186621.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.

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