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Adjuvant Radiotherapy of Sintilimab Versus TACE for HCC

ConditionsHepatocellular Carcinoma (HCC)Radiotherapy, AdjuvantImmune Checkpoint InhibitorTACENarrow Margin
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

This study is an open-label, randomized controlled, multicenter, phase III clinical trial

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sintilimab

    Drug

    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

  • radiotherapy

    Radiation

    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

  • TACE

    Procedure/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.

Treatment groups

286 Participants
are divided into 2 treatment groups
Group A: control groupActive comparator 1 intervention
Group B: experiment groupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

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

Time frame
2-year after randomization

Secondary outcomes

1

2-year OS

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

Time frame
2-year after randomization
2

adverse events

any symptoms, signs, and laboratory examinations abnormality during the clinical trial

Time frame
up to 2 years after randomization

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Lead sponsor

Peking University People's Hospital

Collaborator

Nanfang Hospital, Southern Medical University

Collaborator

Beijing 302 Hospital

Collaborator

Beijing Ditan Hospital

Collaborator

Eastern Hepatobiliary Surgery Hospital

Collaborator

Source ClinicalTrials.gov
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