Overview

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

Status:
Recruiting

Trial end date:
2024-07-31

Target enrollment:
0

Participant gender:
All

Summary

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

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Xiangya Hospital of Central South University

Criteria

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.