Combined Locoregional Treatment With Immunotherapy for Unresectable HCC.

NCT04220944 | Active Not Recruiting Phase 1

• 1 other identifier: ZS-IR-2019B
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Efficacy and Safety of Locoregional treatments Combined With PD-1 Inhibitor in Patients With Unresectable Hepatocellular Carcinoma.

Conditions

Hepatic Carcinoma

Keywords

HCC; Microwave ablation; TACE; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  Progression according to mRECIST for HCC.

  Observation period max 18 months

Secondary Outcomes (4)

• Objective Response Rate (ORR)

  max 18 months

• Time to Progression (TTP)

  max 18 months

• Overall survival (OS)

  max 18 months

• Incidence of Treatment Emergent Adverse Events as assessed by NCI CTCAE V5.0 (Safety and Tolerability)

  max 18 months

Study Arms (1)

Locoregional therapies combined with Anti-PD-1 antibody

EXPERIMENTAL

Percutaneous microwave ablation combined with simultaneous TACE was performed. Sintilimab will be initiated on day 3-7 after the first locoregional therapies. Sintilimab will be administered every three weeks (200mg fixed dose IV) until disease progression for up to one year.The second locoregional procedure will be repeated according to the enhanced CT images.

Drug: Sintilimab; Procedure: Microwave Ablation; Procedure: TACE

Interventions

Sintilimab DRUG

Sintilimab (200mg) was administered intravenously over 30-60 min every 3 weeks.

Also known as: Sintilimab injection, 308004

Locoregional therapies combined with Anti-PD-1 antibody

Microwave Ablation PROCEDURE

The ablation area should covered at least two thirds the size of the nodules.

Locoregional therapies combined with Anti-PD-1 antibody

TACE PROCEDURE

Patient was treated with epirubicin lipiodol emulsion(Epirubicin 40mg, Lipiodol 10ml).Embolic materials such as gelfoam or microsphere was aslo administered until complete stasis in segmental or subsegmental arterial branches.

Locoregional therapies combined with Anti-PD-1 antibody

Eligibility Criteria

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

You may qualify if:

• Age: 18 - 80 years old and life expectancy of at least 12 weeks.;
• Clinically or histologically diagnosed as HCC and the diameter of target tumor lesion ≥ 5 cm;
• Child-pugh classification A or B (score \< 7);
• BCLC Staging as B or C;
• ECOG 0-1;
• Patients voluntarily entered the study and signed informed consent form (ICF).

You may not qualify if:

• History of treatment with any local treatment (exception of liver transplantation), systemic .anti-cancer therapy, or immunotherapy;
• The surgeon assessed that the tumor lesion was not unsuitable for microwave ablation;
• Any contraindications for hepatic embolization procedures:
• Known hepatofugal blood flow;
• Total thrombosis of main portal vein.
• The tumor thrombus of main portal vein, IVC or right atrium;
• Tumor burden ≥ 70% of liver volume; and no measurable site of disease as defined by modified RECIST (mRECIST) criteria with spiral CT scan or MRI;
• Subjects with chronic HBV infection have HBV DNA viral load \> 100 IU/mL at screening, and have not received antiviral therapy prior to initiation of study therapy; In addition, coinfection of HBV and HCV;
• The alcoholic or pregnant women;
• Patients with second primary cancer or history of other cancer within 3 years;
• Diagnosis of active autoimmune disease, immunodeficiency, or patient is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of Sintilimab-monotherapy treatment;
• Blood count, liver function: Haemoglobin \< 9.0 g/dL, white cell count \< 1.0 x10\^9/L; Total bilirubin \> 3 mg/dL; Aspartate Aminotransferase (SGOT) or Alanine aminotransferase (SGPT) \> 5 x upper normal limit (ULN), Albumin \< 2.8g/dL; International normalized ratio (INR) \>2.3;
• Renal function dysfunction: Serum Creatinine \>2 mg/dL or creatinine clearance (CrCl) \< 30 mL/min (if using the Cockcroft-Gault formula ); and severe heart, lung, brain or other organ disease;
• Non-compliance with TACE or ablation procedure.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead
• Innovent Biologics (Suzhou) Co. Ltd.: collaborator

Study Sites (1)

Department of Interventional Radiology, Zhongshan Hospital, Fudan University.

Shanghai, Shanghai Municipality, 200032, 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

• zhiping Yan, MD

  Department of Interventional Radiology, Zhongshan Hospital, Fudan University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2019
• First Posted: January 7, 2020
• Study Start: January 1, 2020
• Primary Completion: October 30, 2024
• Study Completion: December 30, 2024
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)