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Radiotherapy Combined With TKI and Anti-PD-1 Antibody for Stage IIIA Hepatocellular Carcinoma With Portal Vein Tumor Thrombus(PVTT)

Primary Purpose

Stage IIIA Hepatocellular Carcinoma

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Radiotherapy combined with TKI and Anti-PD-1 Antibody
Sponsored by
Fujian Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage IIIA Hepatocellular Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with primary hepatocellular carcinoma who strictly meet the clinical diagnostic criteria of the "Guidelines for the Diagnosis and Treatment of Primary Liver Cancer" (2022 edition) or who have been confirmed by histopathology or human cytology, There was at least one measurable lesion (spiral CT scan length ≥10mm or malignant lymph node short diameter ≥15mm according to RECIST1.1 standard); Patients with advanced primary hepatocellular carcinoma who have not received systematic treatment and cannot be surgically resectable; CNLC was divided into stage IIIA, VP1-3 type; Child-Pugh classification of liver function is grade A (5-6 points); ECOG PS score 0-1; Expected survival ≥12 weeks; Patients with active hepatitis B virus (HBV) infection must be willing to receive antiviral treatment throughout the study period; Hepatitis C virus (HCV) ribonucleic acid (RNA) positive patients must receive antiviral therapy according to standard local treatment guidelines and have liver function within CTCAE level 1 elevation; The major organs function normally and meet the following criteria : The blood routine examination criteria should meet :(no blood transfusion within 14 days) Hemoglobin (HB)≥90g/L, White blood cell count (WBC)≥3×109/L, Absolute neutrophil count (ANC)≥1.5×109/L, platelets (PLT)≥75×109/L; Biochemical examination should meet the following criteria: Bilirubin (BIL)< 1.5 times the upper limit of normal value (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase AST<5ULN; Serum creatinine (Cr)≤1.5ULN Women of childbearing age must have a negative pregnancy test (serum) or urine HCG test within 7 days prior to admission and be willing to use an appropriate method of contraception during the trial and 8 weeks after the last dose of the test drug; For males, they should be surgically sterilized or agree to use appropriate methods to avoid pregnancy during the trial and for 8 weeks after the last dose of the trial drug; The subjects voluntarily joined the study, had good compliance, and cooperated with follow-up. Exclusion Criteria: Pregnant or lactating women; Patients with autoimmune diseases, organ/hematopoietic stem cell transplantation, or other malignancies (except cured cutaneous basal cell carcinoma and cervical carcinoma in situ); Patients with consciousness disorder or inability to cooperate with treatment, combined with mental illness; Patients with a history of epigastric radiotherapy; Patients who fail to follow dose limits for vital organs in the radiotherapy program, including patients with normal liver tissue less than 700 ml in the radiotherapy program; Patients who have participated in other clinical trials in the past three months; Previously received targeted therapy or other PD-1/PD-L1 inhibitor therapy; Received major surgery or chemotherapy, radiation therapy or other focal systemic therapy within 1 month before enrollment; Immunosuppressive agents or systemic hormone therapy (dose >10mg/ day prednisone or other therapeutic hormones) were used within 14 days before enrollment to achieve immunosuppression; Liver function was classified as Child-Pugh C, which could not be improved by liver protection treatment. Esophageal (fundus) varices rupture and bleeding within 1 month before treatment. Uncorrectable coagulation dysfunction and severe blood abnormalities, with a tendency to severe bleeding. Platelet count <50×109/L and severe coagulation dysfunction can not withstand surgery (anticoagulant therapy and/or anticoagulant drug use should be stopped more than 1 week before radiotherapy); Refractory ascites, bad fluid; Active infection, especially inflammation of the biliary system; Severe liver, kidney, heart, lung, brain and other major organ failure; People who have been allergic to any component of PD-1 monoclonal antibody or other similar experimental drugs; Have high blood pressure and can not be reduced to normal by antihypertensive medication

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    treatment group

    Arm Description

    Radiotherapy Combined with TKI and Anti-PD-1 Antibody

    Outcomes

    Primary Outcome Measures

    OS
    Overall survival (OS) was measured from the initiation of transarterial therapy to the date of death or the last follow-up.
    ORR
    Assessed according to the modified Response Evaluation Criteria in Solid Tumors Version 1.1, undergoing enhanced CT/MRI.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 14, 2023
    Last Updated
    September 24, 2023
    Sponsor
    Fujian Cancer Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06061445
    Brief Title
    Radiotherapy Combined With TKI and Anti-PD-1 Antibody for Stage IIIA Hepatocellular Carcinoma With Portal Vein Tumor Thrombus(PVTT)
    Official Title
    A Phase II Study to Evaluate the Effects of Radiotherapy Combined With Tyrosine Kinase Inhibitor (TKI) and Anti-PD-1 Antibody for Stage IIIA Hepatocellular Carcinoma With Portal Vein Tumor Thrombus(PVTT)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2024 (Anticipated)
    Primary Completion Date
    July 30, 2024 (Anticipated)
    Study Completion Date
    December 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fujian Cancer Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The purpose of this clinical research study is to investigate the efficacy and safety of Radiotherapy Combined with TKI and Anti-PD-1 Antibody for Stage IIIA Hepatocellular Carcinoma with Portal Vein Tumor Thrombus(PVTT).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stage IIIA Hepatocellular Carcinoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    22 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    treatment group
    Arm Type
    Experimental
    Arm Description
    Radiotherapy Combined with TKI and Anti-PD-1 Antibody
    Intervention Type
    Combination Product
    Intervention Name(s)
    Radiotherapy combined with TKI and Anti-PD-1 Antibody
    Intervention Description
    After signing informed consent, patients received Anti-PD-1 Antibody 200 mg intravenously on the first day of each cycle, Q3W; Tyrosine Kinase Inhibitor (TKI) was administration started on the first and continually administered until disease progression developed or serious treatment-related toxicity occurred; Cancer thrombus radiotherapy treatment: For the portal vein cancer thrombus site (Total dose 25-30Gy, times 5-6) , Treatment usually starts within 7 days and ends within 1 week after the first cycle of injection of anti PD-1 inhibitors.
    Primary Outcome Measure Information:
    Title
    OS
    Description
    Overall survival (OS) was measured from the initiation of transarterial therapy to the date of death or the last follow-up.
    Time Frame
    the date of first administration to the subject's death from various causes
    Title
    ORR
    Description
    Assessed according to the modified Response Evaluation Criteria in Solid Tumors Version 1.1, undergoing enhanced CT/MRI.
    Time Frame
    The best efficacy recorded between the date of first administration and the date of objective recording of progress according to mRECIST 1.1 criteria or the date of initiation of subsequent antitumor therapy, whichever occurs first

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with primary hepatocellular carcinoma who strictly meet the clinical diagnostic criteria of the "Guidelines for the Diagnosis and Treatment of Primary Liver Cancer" (2022 edition) or who have been confirmed by histopathology or human cytology, There was at least one measurable lesion (spiral CT scan length ≥10mm or malignant lymph node short diameter ≥15mm according to RECIST1.1 standard); Patients with advanced primary hepatocellular carcinoma who have not received systematic treatment and cannot be surgically resectable; CNLC was divided into stage IIIA, VP1-3 type; Child-Pugh classification of liver function is grade A (5-6 points); ECOG PS score 0-1; Expected survival ≥12 weeks; Patients with active hepatitis B virus (HBV) infection must be willing to receive antiviral treatment throughout the study period; Hepatitis C virus (HCV) ribonucleic acid (RNA) positive patients must receive antiviral therapy according to standard local treatment guidelines and have liver function within CTCAE level 1 elevation; The major organs function normally and meet the following criteria : The blood routine examination criteria should meet :(no blood transfusion within 14 days) Hemoglobin (HB)≥90g/L, White blood cell count (WBC)≥3×109/L, Absolute neutrophil count (ANC)≥1.5×109/L, platelets (PLT)≥75×109/L; Biochemical examination should meet the following criteria: Bilirubin (BIL)< 1.5 times the upper limit of normal value (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase AST<5ULN; Serum creatinine (Cr)≤1.5ULN Women of childbearing age must have a negative pregnancy test (serum) or urine HCG test within 7 days prior to admission and be willing to use an appropriate method of contraception during the trial and 8 weeks after the last dose of the test drug; For males, they should be surgically sterilized or agree to use appropriate methods to avoid pregnancy during the trial and for 8 weeks after the last dose of the trial drug; The subjects voluntarily joined the study, had good compliance, and cooperated with follow-up. Exclusion Criteria: Pregnant or lactating women; Patients with autoimmune diseases, organ/hematopoietic stem cell transplantation, or other malignancies (except cured cutaneous basal cell carcinoma and cervical carcinoma in situ); Patients with consciousness disorder or inability to cooperate with treatment, combined with mental illness; Patients with a history of epigastric radiotherapy; Patients who fail to follow dose limits for vital organs in the radiotherapy program, including patients with normal liver tissue less than 700 ml in the radiotherapy program; Patients who have participated in other clinical trials in the past three months; Previously received targeted therapy or other PD-1/PD-L1 inhibitor therapy; Received major surgery or chemotherapy, radiation therapy or other focal systemic therapy within 1 month before enrollment; Immunosuppressive agents or systemic hormone therapy (dose >10mg/ day prednisone or other therapeutic hormones) were used within 14 days before enrollment to achieve immunosuppression; Liver function was classified as Child-Pugh C, which could not be improved by liver protection treatment. Esophageal (fundus) varices rupture and bleeding within 1 month before treatment. Uncorrectable coagulation dysfunction and severe blood abnormalities, with a tendency to severe bleeding. Platelet count <50×109/L and severe coagulation dysfunction can not withstand surgery (anticoagulant therapy and/or anticoagulant drug use should be stopped more than 1 week before radiotherapy); Refractory ascites, bad fluid; Active infection, especially inflammation of the biliary system; Severe liver, kidney, heart, lung, brain and other major organ failure; People who have been allergic to any component of PD-1 monoclonal antibody or other similar experimental drugs; Have high blood pressure and can not be reduced to normal by antihypertensive medication

    12. IPD Sharing Statement

    Learn more about this trial

    Radiotherapy Combined With TKI and Anti-PD-1 Antibody for Stage IIIA Hepatocellular Carcinoma With Portal Vein Tumor Thrombus(PVTT)

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