Anti-PD-1 Antibody Plus DEB-TACE for BCLC Stage A/B HCC

NCT ID: NCT04174781

Last Updated: 2022-06-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-20
• Study Completion Date: 2022-12-30

Brief Summary

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.

Detailed Description

Patients with hepatocellular carcinoma (HCC) of BCLC stage A/B exceeding the Milan criteria have a low resection rate and high postoperative recurrence rate, therefore, optimizing therapy for these patients is an important unmet need. This study aimed to investigate the efficacy and safety of preoperative DEB-TACE plus sintilimab for the treatment of patients with BCLC stage A/B HCC exceeding the Milan criteria.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DEB-TACE+Sintilimab

Participants with BCLC Stage A/B Hepatocellular Carcinoma Beyond the Milan Criteria

Group Type: EXPERIMENTAL

Sintilimab

Intervention Type: DRUG

Sintilimab: 200mg iv Q3W D1

DEB-TACE

Intervention Type: DRUG

DEB-TACE(epirubicin 60mg) D1; Additional DEB-TACE procedures were carried out every 4-6 weeks based on tumor response. A treatment cycle was defined as one DEB-TACE procedure plus two doses of sintilimab. The combination of DEB-TACE and sintilimab was continued for a maximum of 3 cycles until surgical resection, radiologic disease progression, unacceptable toxicity, or withdrawal from the study, whichever occurred first.

Interventions

Sintilimab

Sintilimab: 200mg iv Q3W D1

Intervention Type: DRUG

DEB-TACE

DEB-TACE(epirubicin 60mg) D1; Additional DEB-TACE procedures were carried out every 4-6 weeks based on tumor response. A treatment cycle was defined as one DEB-TACE procedure plus two doses of sintilimab. The combination of DEB-TACE and sintilimab was continued for a maximum of 3 cycles until surgical resection, radiologic disease progression, unacceptable toxicity, or withdrawal from the study, whichever occurred first.

Intervention Type: DRUG

Other Intervention Names

Immunotherapy; Anti-PD-1 therapy; Drug-eluting Bead Transarterial Chemoembolization

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

TingBo Liang

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

the First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Countries

China

References

Guo 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.

Reference Type: DERIVED

PMID: 36757445 (View on PubMed)

Other Identifiers

CISLD-5

Identifier Type: -

Identifier Source: org_study_id