Adjuvant Immunotherapy With Toripalimab Following Curative-intent Ablation for Recurrent Hepatocarcinoma
NCT ID: NCT05240404
Last Updated: 2022-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
116 participants
INTERVENTIONAL
2020-07-01
2024-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A
Patients with recurrent hepatocellular carcinoma would be treated with curative-intent ablation alone.
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.
Arm B
Patients with recurrent hepatocellular carcinoma would be treated with curative-intent ablation and adjuvant immunotherapy with toripalimab.
Toripalimab
toripalimab treatment (240mg intravenously every 3 weeks) started on day 3 after ablation for six months
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.
Interventions
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Toripalimab
toripalimab treatment (240mg intravenously every 3 weeks) started on day 3 after ablation for six months
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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 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.
18 Years
75 Years
ALL
No
Sponsors
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Xiangya Hospital of Central South University
OTHER
Responsible Party
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Principal Investigators
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Liangrong Shi, M.D.
Role: PRINCIPAL_INVESTIGATOR
Xiangya Hospital of Central South University
Locations
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Xiangya Hospital, Central South University
Changsha, Hunan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRTOE
Identifier Type: -
Identifier Source: org_study_id
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