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

NCT04174781 | Unknown Phase 2

• 1 other identifier: CISLD-5
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular carcinoma; Transarterial chemoembolization; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS) per mRECIST

  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).

  36 months

Secondary Outcomes (6)

• 12 mo PFS rate

  36 months

• Overall survival (OS)

  36 months

• Pathological Response

  6 months

• Objective Response Rate (ORR) per mRECIST

  36 months

• Disease Control Rate (DCR) per mRECIST

  36 months

Study Arms (1)

DEB-TACE+Sintilimab

EXPERIMENTAL

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

Drug: Sintilimab; Drug: DEB-TACE

Interventions

Sintilimab DRUG

Sintilimab: 200mg iv Q3W D1

Also known as: Immunotherapy, Anti-PD-1 therapy

DEB-TACE+Sintilimab

DEB-TACE 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.

Also known as: Drug-eluting Bead Transarterial Chemoembolization

DEB-TACE+Sintilimab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 years and 75 years;
• ECOG PS 0/1;
• 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
• Have not received any anti-tumor systemic treatment in the past
• No contraindications for the treatment of DEB-TACE and PD-1 inhibitors;
• Liver function: Child-Pugh score Class A
• The expected survival of the patient is more than 3 months
• 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
• Adequate bone marrow, cardiac, and renal function
• Patients must agree to accept postoperative follow-up required by the design of this study;
• 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.

You may not qualify if:

• History of other malignancies；
• 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)；
• With uncontrolled hepatitis B (HBV-DNA\>2000 IU/ml and elevated ALT).
• Spontaneous rupture and bleeding of HCC
• Hepatic tumor burden \>50% total liver volume
• Complete occlusion of the portal vein
• Evidence of a bleeding diathesis or coagulopathy, active infections, and autoimmune disease
• Recurrent disease after surgery within the last 5 years
• History of organ transplantation or plan to have liver transplantation;
• Pregnant women, nursing mothers.
• Patients have other factors that may interfere with patient enrollment and assessment results.
• Refuse follow-up as required by this study protocol and refuse to sign informed consent.

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (1)

the First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

Related Publications (1)

• 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.

  PMID: 36757445 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

sintilimab; Immunotherapy

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)

Immunomodulation; Biological Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: A Phase II Single-arm, Open-label Study

Study Record Dates

• First Submitted: November 20, 2019
• First Posted: November 22, 2019
• Study Start: November 20, 2019
• Primary Completion: July 30, 2022
• Study Completion: December 30, 2022
• Last Updated: June 9, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)