Adjuvant Immunotherapy With Toripalimab Following Curative-intent Ablation for Recurrent Hepatocarcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:

A Randomized Phase II Study of Adjuvant Immunotherapy With Toripalimab Following Curative-intent Ablation for Recurrent Hepatocarcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05240404
• Other study ID #: IRTOE
• Status: Recruiting
• Phase: Phase 2
• Start date: July 1, 2020
• Est. completion date: July 31, 2024

Study information

• Verified date: February 2022
• Source: Xiangya Hospital of Central South University
• Contact: Liangrong Shi, M.D.
• Phone: +8613974886662
• Email: shiliangrong[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This phase II study is to evaluate the efficacy of the adjuvant immunotherapy after curative-intent ablation for recurrent hepatocarcinoma

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 116
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

HCC diagnosed as (i) the presence of risk factors including hepatitis B or C virus and liver cirrhosis, a serum a-fetoprotein (AFP) level greater than 200 IU/ml and a radiologically compatible feature with HCC in one or more CT/MRI/angiograms, or (ii) the presence of risk factors including hepatitis B or C virus and liver cirrhosis, a serum a-fetoprotein (AFP) level less than 200 IU/ml, and a radiologically compatible feature with HCC in two or more CT/MRI/angiograms or (iii) histological confirmation.

HCC patients who had recurrent or residual tumor after other treatments without evidence of extrahepatic metastasis the largest diameter of tumor should be less than 3cm, and the number of tumor =2 no previous treatment to target tumors by other forms of RT.

liver function of Child-Pugh class A or B7 (Child-Pugh score of =7). performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) score.

WBC count = 2,000/mm3; hemoglobin level = 7.5 g/dL; platelet count = 50,000/mm3; and adequate hepatic function (total bilirubin = 3.0 mg/dL; AST and ALT < 5.0× upper limit of normal; no ascites).

no serious comorbidities other than liver cirrhosis. written informed consent.

Exclusion Criteria:

HCC diagnosed as (i) the presence of risk factors including hepatitis B or C virus and liver cirrhosis, a serum a-fetoprotein (AFP) level greater than 200 IU/ml and a radiologically compatible feature with HCC in one or more CT/MRI/angiograms, or (ii) the presence of risk factors including hepatitis B or C virus and liver cirrhosis, a serum a-fetoprotein (AFP) level less than 200 IU/ml, and a radiologically compatible feature with HCC in two or more CT/MRI/angiograms or (iii) histological confirmation.

HCC patients who had recurrent or residual tumor after other treatments without evidence of extrahepatic metastasis the largest diameter of tumor should be less than 3cm, and the number of tumor =2 no previous treatment to target tumors by other forms of RT.

Liver function of Child-Pugh class A or B7 (Child-Pugh score of =7). Performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) score.

WBC count = 2,000/mm3; hemoglobin level = 7.5 g/dL; platelet count = 50,000/mm3; and adequate hepatic function (total bilirubin = 3.0 mg/dL; AST and ALT < 5.0× upper limit.

Written informed consent.

Exlusion criteria:

Evidence of extrahepatic metastasis. Liver function of Child-Pugh class B8-9 and C (Child-Pugh score of >7). Previous history of other forms of RT adjacent to target tumors. Poor performance status of 3 to 4 on the Eastern Cooperative Oncology Group (ECOG) score.

Pregnant or breast feeding status. Previous history uncontrolled other malignancies within 2 years.

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Toripalimab
toripalimab treatment (240mg intravenously every 3 weeks) started on day 3 after ablation for six months

Procedure:
• Thermal ablation
The ablation operation was performed under local or compound anesthesia and guided by ultrasonography (US) or computed tomography (CT). To ensure complete destruction of the tumor, the ablation area must exceed the tumor boundary 1.0 cm.

Locations

Country	Name	City	State
China	Xiangya Hospital, Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival	Disease-free survival was defined as the interval from the date of randomization to date of detection new recurrent disease	up to 3 years until study closed
Secondary	Overall survival	Overall survival (OS) was defined as the interval from the date of randomization to death or study closed	up to 3 years until study closed
Secondary	Number of participants with adverse events	Evaluation will be done using NCI-CTCAE (version 4.03).	Up to approximately 3 years
Secondary	Predictive Biomarkers	Tissue and blood biomarkers in including PD-L1 expression, tumor mutation burden defined as the number of non-inherited mutations per million bases of investigated genomic sequence	Up to approximately 3 years