Adjuvant Immunotherapy With Toripalimab Following Curative-intent Ablation for Recurrent Hepatocarcinoma
Study Details
Study Description
Brief Summary
This phase II study is to evaluate the efficacy of the adjuvant immunotherapy after curative-intent ablation for recurrent hepatocarcinoma
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Arm A Patients with recurrent hepatocellular carcinoma would be treated with curative-intent ablation alone. |
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.
Other Names:
|
| Experimental: Arm B Patients with recurrent hepatocellular carcinoma would be treated with curative-intent ablation and adjuvant immunotherapy with toripalimab. |
Drug: Toripalimab
toripalimab treatment (240mg intravenously every 3 weeks) started on day 3 after ablation for six months
Other Names:
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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Disease-free survival [up to 3 years until study closed]
Disease-free survival was defined as the interval from the date of randomization to date of detection new recurrent disease
Secondary Outcome Measures
- Overall survival [up to 3 years until study closed]
Overall survival (OS) was defined as the interval from the date of randomization to death or study closed
- Number of participants with adverse events [Up to approximately 3 years]
Evaluation will be done using NCI-CTCAE (version 4.03).
- Predictive Biomarkers [Up to approximately 3 years]
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
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Xiangya Hospital, Central South University | Changsha | Hunan | China | 410005 |
Sponsors and Collaborators
- Xiangya Hospital of Central South University
Investigators
- Principal Investigator: Liangrong Shi, M.D., Xiangya Hospital of Central South University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRTOE