TACE Combined with Anti-PD-1 Antibody in Patients with Advanced Hepatocellular Carcinoma

NCT04297280 | Completed Phase 2

• 1 other identifier: 1905201-11
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the efficacy and safety of transcatheter arterial chemoembolization combined with anti-pd-1 antibody in patients with advanced hepatocellular carcinoma as first line therapy.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  ORR according to RECIST v1.1 for Hepatocellular Carcinoma

  max 24 months

Secondary Outcomes (5)

• Duration of Response

  max 24 months

• Progression Free Survival

  max 24 months

• overall survival

  max 42 months

• disease control rate

  max 24 months

• Adverse Events

  max 42 months

Study Arms (1)

TACE in combination with sintilimab

EXPERIMENTAL

One-session TACE treatment starts at day 0. Sintilimab will be initiated on day 14 after TACE. Sintilimab will be administered every three weeks (200mg fixed dose IV) until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.

Drug: Sintilimab; Combination Product: TACE

Interventions

Sintilimab DRUG

a PD-1 immune check inhibitor

TACE in combination with sintilimab

TACE COMBINATION_PRODUCT

TACE is performed by using drug eluting beads, or using embolic agent combined with Lipiodol-pirarubicin emulsion per Investigator decision

TACE in combination with sintilimab

Eligibility Criteria

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

You may qualify if:

• Written informed consent obtained.
• Age ≥ 18 years at time of study entry.
• BCLC stage C, and stage B who are not amenable to curative or locoregional therapies or have progressed thereafter.
• Histologically confirmed diagnosis of hepatocellular carcinoma.
• At least one measurable site of disease as defined by modified RECIST (mRECIST) criteria with spiral CT scan or MRI.
• Child-Pugh scores 5-7, performance status (PS) ≤ 2 (ECOG scale).
• Subjects with chronic HBV infection must have HBV DNA viral load \< 100 IU/mL at screening. In addition, they must be on antiviral therapy per regional standard of care guidelines prior to initiation of study therapy.
• Life expectancy of at least 12 weeks.
• Adequate blood count, liver-enzymes, and renal function: absolute neutrophil count ≥ 1,500/L, platelets ≥60 x103/L; Total bilirubin ≤ 3x upper normal limit; Aspartate Aminotransferase (SGOT), Alanine aminotransferase (SGPT) ≤ 5 x upper normal limit (ULN); International normalized ratio (INR) ≤1.25; Albumin ≥ 31 g/dL; Serum Creatinine ≤ 1.5 x institutional ULN or creatinine clearance (CrCl) ≥ 30 mL/min (if using the Cockcroft-Gault formula )
• Female patients with reproductive potential must have a negative urine or serum pregnancy test within 7 days prior to start of trial.
• Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment, adherence to contraceptive measures, scheduled visits and examinations including follow up.

You may not qualify if:

• PVTT with complete obstructive invasion of the main trunk of the portal vein.
• Patients on a liver transplantation list or with advanced liver disease.
• Total thrombosis or total invasion of the main branch of the portal vein.
• History of cardiac disease, including clinically significant gastrointestinal bleeding within 4 weeks prior to start of study treatment
• Thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months Prior to the first dose of study drug with the exception of thrombosis of a segmental portal vein.
• Prior systemic anti-cancer therapy OR endocrine- OR immunotherapy.
• Radiofrequency ablation and resection administered less then 4 weeks prior to study treatment start.
• Radiotherapy administered less then 4 weeks prior to study treatment start.
• Major surgery within 4 weeks of starting the study treatment OR subjects who have not recovered from effects of major surgery.
• Patients with second primary cancer, except adequately treated basal skin cancer or carcinoma in-situ of the cervix.
• Immunocompromised patients, e.g. patients who are known to be serologically positive for human immunodeficiency virus (HIV).
• Previous treatment in the present study (does not include screening failure).
• Any condition or comorbidity that, in the opinion of the investigator, would interfere with evaluation of study Treatment or interpretation of patient safety or study results, including but not limited to:
• history of interstitial lung disease
• Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) coinfection (i.e double infection)

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

sintilimab

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

Study Officials

• Peng Wang, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

• Zhiqiang Meng, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

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: Professor

Study Record Dates

• First Submitted: March 4, 2020
• First Posted: March 5, 2020
• Study Start: April 29, 2020
• Primary Completion: July 18, 2023
• Study Completion: February 25, 2025
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)