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Combined Locoregional Treatment With Immunotherapy for Unresectable HCC.

Primary Purpose

Hepatic Carcinoma

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Sintilimab

Microwave Ablation

TACE

About this trial

This is an interventional treatment trial for Hepatic Carcinoma focused on measuring HCC, Microwave ablation, TACE, Immunotherapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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).

Exclusion Criteria:

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:
1. Known hepatofugal blood flow;
2. 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.

Sites / Locations

Department of Interventional Radiology, Zhongshan Hospital, Fudan University.Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Locoregional therapies combined with Anti-PD-1 antibody

Arm Description

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.

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS)

Progression according to mRECIST for HCC.

Secondary Outcome Measures

Objective Response Rate (ORR)

Objective Response Rate according to mRECIST for HCC

Time to Progression (TTP)

It is defined as the time from first locoregional therapy to the date of the first documented tumor progression according to the definition above.

Overall survival (OS)

Overall survival is defined as the time from first locoregional therapy until death

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

Data will be obtained on vital signs, clinical parameters and feasibility of the regimen

Full Information

NCT ID

NCT04220944

First Posted

December 29, 2019

Last Updated

September 23, 2021

Sponsor

Shanghai Zhongshan Hospital

Collaborators

Innovent Biologics (Suzhou) Co. Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04220944

Brief Title

Combined Locoregional Treatment With Immunotherapy for Unresectable HCC.

Official Title

Microwave Ablation Combined With Simultaneous TACE Plus Sintilimab for Unresectable HCC.

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Unknown status

Study Start Date

January 1, 2020 (Actual)

Primary Completion Date

June 30, 2022 (Anticipated)

Study Completion Date

September 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai Zhongshan Hospital

Collaborators

Innovent Biologics (Suzhou) Co. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

Brief Summary

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

Detailed Description

Hepatocellular carcinoma is the most frequent primary and ranked as the sixth most common neoplasm and the third leading cause of cancer death. Percutaneous ablation and TACE are the effective locoregional treatments for the patient with HCC. Moreover, some studies suggested that TACE combined with ablation could further improve the survival rate and reduce the post-operation complication. Although PD-1 inhibitor was approved by FDA for HCC, the latest RCT indicated that no significant difference was found in the ORR and PFS between the groups of PD-1 inhibitor and Sorafenib. Therefore, this study aims to assess the efficacy and safety of microwave ablation combined with simultaneous TACE plus PD-1 inhibitor for the non-resectable HCC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatic Carcinoma

Keywords

HCC, Microwave ablation, TACE, Immunotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Locoregional therapies combined with Anti-PD-1 antibody

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Sintilimab

Other Intervention Name(s)

Sintilimab injection, 308004

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Microwave Ablation

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

TACE

Intervention Description

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.

Primary Outcome Measure Information:

Title

Progression Free Survival (PFS)

Description

Progression according to mRECIST for HCC.

Time Frame

Observation period max 18 months

Secondary Outcome Measure Information:

Title

Objective Response Rate (ORR)

Description

Objective Response Rate according to mRECIST for HCC

Time Frame

max 18 months

Title

Time to Progression (TTP)

Description

It is defined as the time from first locoregional therapy to the date of the first documented tumor progression according to the definition above.

Time Frame

max 18 months

Title

Overall survival (OS)

Description

Overall survival is defined as the time from first locoregional therapy until death

Time Frame

max 18 months

Title

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

Description

Data will be obtained on vital signs, clinical parameters and feasibility of the regimen

Time Frame

max 18 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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). Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

zhiping Yan, MD

Phone

+8613681971205

yan.zhiping@zs-hospital.sh.cn

First Name & Middle Initial & Last Name or Official Title & Degree

minjie Yang, MD

Phone

+8613818947653

yang.minjie@zs-hospital.sh.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

zhiping Yan, MD

Organizational Affiliation

Department of Interventional Radiology, Zhongshan Hospital, Fudan University

Official's Role

Study Director

Facility Information:

Facility Name

Department of Interventional Radiology, Zhongshan Hospital, Fudan University.

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

minjie Yang, MD

Phone

+8613818947653

yang.minjie@zs-hospital.sh.cn

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Combined Locoregional Treatment With Immunotherapy for Unresectable HCC.

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