Combined Locoregional Treatment With Immunotherapy for Unresectable HCC.

NCT ID: NCT04220944

Last Updated: 2024-08-01

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2024-12-30

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.

Conditions

Hepatic Carcinoma

Study Design

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

Study Groups

Locoregional therapies combined with Anti-PD-1 antibody

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.

Group Type: EXPERIMENTAL

Sintilimab

Intervention Type: DRUG

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

Microwave Ablation

Intervention Type: PROCEDURE

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

TACE

Intervention Type: 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.

Interventions

Sintilimab

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

Intervention Type: DRUG

Microwave Ablation

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

Intervention Type: PROCEDURE

TACE

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.

Intervention Type: PROCEDURE

Other Intervention Names

Sintilimab injection, 308004

Eligibility Criteria

Inclusion Criteria

1. Age: 18 - 80 years old and life expectancy of at least 12 weeks.;

2. Clinically or histologically diagnosed as HCC and the diameter of target tumor lesion ≥ 5 cm;

3. Child-pugh classification A or B (score < 7);

4. BCLC Staging as B or C;

5. ECOG 0-1;

6. Patients voluntarily entered the study and signed informed consent form (ICF).

Exclusion Criteria

1. History of treatment with any local treatment (exception of liver transplantation), systemic .anti-cancer therapy, or immunotherapy;

2. The surgeon assessed that the tumor lesion was not unsuitable for microwave ablation;

3. Any contraindications for hepatic embolization procedures:

1. Known hepatofugal blood flow;

2. Total thrombosis of main portal vein.

4. The tumor thrombus of main portal vein, IVC or right atrium;

5. 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;

6. 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;

7. The alcoholic or pregnant women;

8. Patients with second primary cancer or history of other cancer within 3 years;

9. 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;

10. 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;

11. 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;

12. Non-compliance with TACE or ablation procedure.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Innovent Biologics (Suzhou) Co. Ltd.

INDUSTRY

Sponsor Role: collaborator

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

zhiping Yan, MD

Role: STUDY_DIRECTOR

Department of Interventional Radiology, Zhongshan Hospital, Fudan University

Locations

Department of Interventional Radiology, Zhongshan Hospital, Fudan University.

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

ZS-IR-2019B

Identifier Type: -

Identifier Source: org_study_id