Last updated: August 31, 2023
Sponsor: HuiKai Li
Overall Status: Active - Not Recruiting
Phase
2
Condition
Cancer
Liver Disease
Liver Disorders
Treatment
Adebrelimab
HAIC
Bevacizumab
Clinical Study ID
NCT05975463
SHR1316-HCC-TJ-001
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Non resectable advanced hepatocellular carcinoma confirmed by pathological andclinical imaging examinations.
- Patients who have previously received systematic treatment combined with failed orintolerable interventional therapy.
- Male or female, aged ≥ 18 years at the time of signing the Informed consent form (ICF).
- The liver should have at least one measurable target lesion (RECIST v1.1). If it isan active lesion after local treatment (radiotherapy, ablation, transcatheter arterialchemoembolization, etc.), local treatment should be completed 4 weeks before thescreening period imaging examination.
- The patient's Eastern Oncology Collaborative Group (ECOG) physical condition scoreis 0 or 1.
- The patient's organ and blood system functions meet the requirements:
- Hematology function: Absolute neutrophil count (ANC) ≥ 1.5 x 10 ^ 9/L, plateletcount ≥ 75 x 10 ^ 9/L
- Adequate renal function: serum creatinine<1.5x ULN or creatinine clearancerate>40 mL/min (Cockcroft Fault formula)
- Liver function: Total bilirubin ≤ 1.5 x ULN, Aspartate aminotransferase (AST) andAlanine aminotransferase (ALT) ≤ 5 x ULN
- Coagulation function: Within the normal range of Prothrombin time (PT) .
- Female participants with Fertility need to carry out serum pregnancy test within 72hours before starting the study drug administration, and the result is negative, andtake effective contraceptive measures (such as Intrauterine device, contraceptive pillor pregnancy avoidance condom) during the test period and at least 3 months after thelast administration; For male participants whose partners are Fertility women, theyshould be surgically sterilized or agree to take effective contraceptive measuresduring the trial period and within 3 months after the last administration.
- The participants have good compliance and cooperate with follow-up.
Exclusion
Exclusion Criteria:
- Has a history of allergies to any component of the study drug in the past;
- Known to be allergic to Programmed Death-1/Programmed Death-L1 (PD-1/PD-L1)antibodies or have experienced drug-related Immune related adverse events (irAEs) inthe past, in accordance with the "Guidelines Of Chinese Society Of Clinical Oncology [CSCO]Management Of Immune Checkpointinhibitor-Related Toxicity 2019", it meets theindication for permanent discontinuation of medication;
- There are known Contraindication of percutaneous hepatic artery infusion;
- Has received or is currently receiving any of the following treatments in the past:
- The patient underwent major surgical procedures within 14 days prior to enteringthe study (puncture biopsy is not included)
- Previous or planned immune therapy such as Chimeric antigen receptor T cellimmunotherapy (CAR-T) and vaccines
- Have any active autoimmune disease or history of autoimmune disease, including butnot limited to interstitial pneumonia, enteritis, hepatitis, hypophysitis, Vasculitis,nephritis, hyperthyroidism, hypothyroidism (it can be considered to be included afterhormone replacement treatment); Patients with psoriasis or childhood asthma/allergythat has completely alleviated and does not need any intervention after adulthood canbe considered for inclusion, but patients who need medical intervention withBronchiectasis cannot be included;
- Poor nutritional status, BMI<18.5 Kg/m2; If symptomatic nutritional support isprovided and corrected before enrollment, and evaluated by the main investigator,enrollment can continue to be considered;
- Have a history of immune deficiency, including positive Diagnosis of HIV/AIDS, orhave other acquired or congenital immune deficiency diseases, or have a history oforgan transplantation or allogeneic bone marrow transplantation;
- There are clinical symptoms or diseases of the heart that cannot be wellcontrolled, including but not limited to: (1) New York Heart Association (NYHA)gradeII or above heart failure, (2) unstable angina pectoris, (3) myocardial infarctionwithin 1 year, (4) clinically significant supraventricular or ventricular arrhythmiasthat have not undergone clinical intervention or are still poorly controlled afterclinical intervention;
- Serious infection (CTCAE>grade 2) occurred within 4 weeks before the first use ofthe study drug, such as severe pneumonia, Bloodstream infections, infectioncomplications, etc. requiring hospitalization; Baseline chest imaging examinationindicates the presence of active pulmonary inflammation, symptoms and signs ofinfection within 14 days prior to the first use of the study drug, or the need fororal or intravenous antibiotic treatment, excluding prophylactic use of antibiotics;
- Those who have been found to have active pulmonary tuberculosis infection throughmedical history or CT examination, or have a history of active pulmonary tuberculosisinfection within 1 year before enrollment, or have a history of active pulmonarytuberculosis infection more than 1 year before but have not received formal treatment;
- There is active hepatitis B (HBV DNA ≥ 2000 IU/mL or 104 copies/mL) and hepatitisC (hepatitis C antibody is positive, and HCV RNA is higher than the detection limit ofthe analytical method);
- Other malignant tumors were diagnosed within 5 years before the first use of thestudy drug, except for malignant tumors with low risk of metastasis or death (5-yearsurvival rate>90%), such as fully treated skin Basal-cell carcinoma or squamous cellskin cancer or cervical Carcinoma in situ, which can be considered to be included inthe group;
- Pregnant or lactating women;
- Previous history of hypertensive crisis or hypertensive encephalopathy;
- Use Nonsteroidal anti-inflammatory drug (NSAIDs) for long-term daily treatment;
- Untreated or incompletely treated esophageal and/or gastric varices with high riskof bleeding or bleeding;
- Previous bleeding events caused by esophageal and/or gastric varices within 6months prior to the start of the study treatment;
- According to the judgment of the investigators, there are other factors that maylead to forced termination of the study, such as suffering from other seriousillnesses (including mental illness) requiring concurrent treatment, alcoholism, drugabuse, family or social factors, which may affect the safety or compliance of theparticipants.
Study Design
Total Participants: 30
Treatment Group(s): 3
Primary Treatment: Adebrelimab
Phase: 2
Study Start date:
September 15, 2023
Estimated Completion Date:
July 31, 2026
Connect with a study center
Tianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin 300308
ChinaSite Not Available

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