Clinical trial · Interventional
Anti-PD-1 Antibody Plus DEB-TACE for BCLC Stage A/B HCC
Preoperative Anti-PD-1 Antibody Plus Drug-eluting Bead TACE for BCLC Stage A/B Hepatocellular Carcinoma Beyond the Milan Criteria: A Phase II Trial
NCT04174781CI-TRIAL-00058988unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aimed to evaluate the efficacy and the safety of the anti-programmed-death-1 antibody (anti-PD-1) Sintilimab Injection in combination with transarterial chemoembolization with drug-eluting beads(TACE-DEB) in patients with BCLC Stage A/B Hepatocellular Carcinoma Beyond the Milan Criteria.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DEB-TACE | Drug | — | UNRESOLVED |
| Sintilimab | Drug | Sintilimab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- DEB-TACE+Sintilimab
- description
- Participants with BCLC Stage A/B Hepatocellular Carcinoma Beyond the Milan Criteria
- interventionNames
- Drug: Sintilimab
- Drug: DEB-TACE
Primary outcomes (1)
- measure
- Progression Free Survival (PFS) per mRECIST
- timeFrame
- 36 months
- description
- The duration from treatment initiation to PD in patients who cannot undergo surgery, or to the date of postoperative relapse in patients who receive surgery, or death for any reason, whichever occurs first (according to mRECIST).
Secondary outcomes (6)
- measure
- 12 mo PFS rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria 1. Age between 18 years and 75 years; 2. ECOG PS 0/1; 3. Patients with histologically- or clinically-confirmed HCC (based on the American Association for the Study of Liver Diseases criteria) that was either BCLC stage A and exceeded the Milan criteria, or BCLC stage B 4. Have not received any anti-tumor systemic treatment in the past 5. No contraindications for the treatment of DEB-TACE and PD-1 inhibitors; 6. Liver function: Child-Pugh score Class A 7. The expected survival of the patient is more than 3 months 8. The following conditions must be met: Platelets ≥ 75 × 10\^9/L White blood cell count (WBC) ≥ 3.0 × 10\^9/L Hemoglobin ≥ 90 g/L Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN); total bilirubin (TBIL) ≤ 1.5 × ULN Blood creatinine ≤ 1.5 × ULN PT prolonged ≤ 3 s 9. Adequate bone marrow, cardiac, and renal function 10. Patients must agree to accept postoperative follow-up required by the design of this study; 11. Patients must have the ability to understand and voluntarily sign the informed consent, and must sign an informed consent before starting any specific procedure for the study. Exclusion Criteria 1. History of other malignancies; 2. In combined with severe heart, lung, kidney or other important organ dysfunction, or combined with serious infection or other serious associated diseases, that cannot tolerate treatment (\> CTCAE Version 5.0 adverse events of grade 2); 3. With uncontrolled hepatitis B (HBV-DNA\>2000 IU/ml and elevated ALT). 4. Spontaneous rupture and bleeding of HCC 5. Hepatic tumor burden \>50% total liver volume 6. Complete occlusion of the portal vein 7. Evidence of a bleeding diathesis or coagulopathy, active infections, and autoimmune disease 8. Recurrent disease after surgery within the last 5 years 9. History of organ transplantation or plan to have liver transplantation; 10. Pregnant women, nursing mothers. 11. Patients have other factors that may interfere with patient enrollment and assessment results. 12. Refuse follow-up as required by this study protocol and refuse to sign informed consent.
References
Publications (1)
- DERIVEDGuo C, Zhang J, Huang X, Chen Y, Sheng J, Huang X, Sun J, Xiao W, Sun K, Gao S, Que R, Shen Y, Zhang M, Wu J, Bai X, Liang T. Preoperative sintilimab plus transarterial chemoembolization for hepatocellular carcinoma exceeding the Milan criteria: A phase II trial. Hepatol Commun. 2023 Feb 9;7(3):e0054. doi: 10.1097/HC9.0000000000000054. eCollection 2023 Mar 1. PMID 36757445