Adjuvant Radiotherapy of Sintilimab Versus TACE for HCC

NCT07186621 | Recruiting Phase 3

• 1 other identifier: NCC5448
• Study Type: interventional
• Target: 286
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hepatocellular Carcinoma (HCC); Radiotherapy, Adjuvant; Immune Checkpoint Inhibitor; TACE; Narrow Margin

Keywords

hepatocellular carcinoma; radiotherapy; narrow margin; sintilimab; TACE

Outcome Measures

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

  2-year after randomization

Secondary Outcomes (2)

• 2-year OS

  2-year after randomization

• adverse events

  up to 2 years after randomization

Study Arms (2)

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.

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.

Drug: Sintilimab; Radiation: radiotherapy

Interventions

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

experiment group

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

experiment group

TACE PROCEDURE

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.

control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead
• 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

Study Sites (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

sintilimab; Radiotherapy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Shuhang Wang

  NCC, CICAMS

  STUDY DIRECTOR

Central Study Contacts

Bo Chen, MD.

CONTACT

8610-87788245; chenboo@outlook.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: September 22, 2025
• Study Start: July 10, 2025
• Primary Completion (Estimated): July 9, 2027
• Study Completion (Estimated): November 30, 2028
• Last Updated: September 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)