Combined Locoregional Treatment With Immunotherapy for Unresectable HCC.

Fudan University

Status and phase: Active, not recruiting; Phase 1

Conditions: Hepatic Carcinoma

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04220944

ZS-IR-2019B

Details and patient eligibility

About

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

Full 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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Locoregional therapies combined with Anti-PD-1 antibody

Experimental group

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.

Treatment:

Procedure: Microwave Ablation

Procedure: TACE

Drug: Sintilimab