Status:
UNKNOWN
IBR900 Cell Injection Combined With Lenvatinib or Bevacizumab in the Treatment of Advanced Primary Liver Cancer
Lead Sponsor:
Shandong Public Health Clinical Center
Collaborating Sponsors:
Imbioray (Hangzhou) Biomedicine Co., Ltd.
Conditions:
Advanced Primary Liver Cancer
Eligibility:
All Genders
18-75 years
Phase:
EARLY_PHASE1
Brief Summary
This is an open-label, nonrandomized investigator-initiated clinical trial to evaluate the safety, tolerability, and efficacy of IBR900 cell injection in combination with Lenvatinib or bevacizumab in ...
Detailed Description
Two treatment groups are set up in this study. The first treatment group is IBR900 cell injection combined with Lenvatinib. The second treatment group is IBR900 cell injection combined with bevacizuma...
Eligibility Criteria
Inclusion
- Male or female, age≥18 and ≤75 years old.
- Subjects with stage IIb, # or IV unresectable / advanced primary hepatocellular carcinoma, intrahepatic cholangiocarcinoma or mixed hepatocellular cholangiocarcinoma diagnosed in accordance with the Guidelines for Diagnosis and Treatment of Primary Liver Cancer of CSCO(2020 Edition).
- Having ≥ 1 measurable lesion in accordance with the modified Response Evaluation Criteria in Solid Tumors (mRECIST) (lesions located in the field of previous radiation therapy cannot be used as target lesions unless there is imaging evidence that the lesion has progressed or persisted three months after radiation therapy).
- Have a performance status of 0 or 2 on the ECOG Performance Score, life expectancy ≥12 weeks.
- Male and female subjects of childbearing age and their partners must agree to take effective birth controls (hormone, barrier method or abstinence, etc.) from signing the ICF to 6 months after the last administration.
- Subjects should voluntarily participate in this clinical study, are fully aware of the study, have signed the Informed Consent Forms, and are willing to follow and able to complete all trial procedures.
Exclusion
- Received systemic anti-tumor therapy within 4 weeks prior to the first administration, including chemotherapy, immunotherapy, radical radiotherapy, etc.; received palliative radiotherapy within 2 weeks prior to the first administration; or the adverse events caused by previous anti-tumor therapy have not recovered to ≤Grade 1 (except for alopecia).
- Have known central nervous system metastases with clinical symptoms.
- Received any adoptive cellular immunotherapy within 6 months prior to the first administration.
- Have undergone major organ surgery (excluding needle biopsy or surgery related to this indication) within 4 weeks prior to their first administration of the study drug, or required elective surgery during the study period.
- Have received or expected to receive glucocorticoids (prednisone \>10 mg daily or equivalents) or other immunosuppressive medications within 14 days prior to the first administration. Note: For subjects without active autoimmune disorder, inhaled or topical steroid hormone or equivalent dose of prednisone ≤ 10 mg/day is allowed, and glucocorticoid is allowed for short-term (≤ 7 days) preventive treatment (e.g. contrast media allergy) or for the treatment of non-autoimmune disorder (e.g. delayed type hypersensitivity to contact allergens).
- Received live or attenuated vaccine within 4 weeks prior to the first administration or plan to receive live or attenuated vaccine during the study period.
- Patients with severe infections that cannot be controlled.
- Patients with a known history of human immunodeficiency virus (HIV) active infection.
- Have active autoimmune diseases or have had autoimmune diseases that are likely to recur (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, vasculitis, psoriasis, etc.). Except in the following cases: type 1 diabetes well controlled with hormone replacement therapy, hypothyroidism, skin conditions not requiring systemic therapy (such as vitiligo), and other conditions that are well controlled and that are less likely to relapse as by the investigator (such as resolved childhood asthma).
- Organ function during screening should meet the following criteria:
- Absolute neutrophil count (ANC)\<1.5×10\^9/L, platelet (PLT)\<75×10\^9/L, hemoglobin (Hb)\<80g/L, (blood transfusion, platelet and colony stimulating factor therapy are not allowed within 2 weeks before the test);
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)\>5 times the upper limit of normal (ULN), and total serum bilirubin\>2.5 times the upper limit of normal (ULN);
- Creatinine(Cr)\>1.5×ULN, and creatinine clearance rate(Ccr) ≤ 60ml/min (estimated according to Cockcroft-Gault formula). Note: Ccr to be calculated only when Cr \>1.5×ULN;
- International normalized ratio (INR) ≤ 2.0×ULN, activated partial thrombin time (APTT) \>1.5×ULN.
- Have a history of serious cardiovascular and cerebrovascular diseases, including but not limited to:
- There are serious cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia, and Ⅱ-Ⅲ degree atrioventricular block, which need clinical intervention;
- The mean QT interval corrected by Fridericia method (QTcF) is prolonged (male\>450ms, female\>470ms);
- Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other grade 3 or above cardiovascular and cerebrovascular events occurring within 6 months before the first administration;
- Patients with heart failure or left ventricular ejection fraction (LVEF) \< 50% in the New York Heart Association (NYHA) classification ≥II;
- Hypertension beyond clinical control;
- Subjects with previous or current interstitial lung disease, pneumoconiosis, radiation pneumonia, severe impairment of pulmonary function that may interfere with the detection and treatment of suspected drug-related pulmonary toxicity. Or uncontrolled systemic diseases, including diabetes, etc.
- Had other malignant tumors in the past 3 years, except for any type of carcinoma in situ that has been cured in the past and cured skin basal cell carcinoma or skin squamous cell carcinoma.
- Pregnant women or lactating women.
- Have a history of drug abuse.
- Patients with a history of serious dementia, mental status changes or any history of mental disorder, incapacity or limited capacity.
- Have participated in other clinical trials and received any unmarketed investigational drug or treatment within 4 weeks prior to the first administration.
- Patients who have received anti-tumor treatment with lenvatinib and bevacizumab.
- According to the judgment of the investigators, other factors that may make the subjects unsuitable for the study.
Key Trial Info
Start Date :
June 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2023
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT05411757
Start Date
June 30 2022
End Date
December 30 2023
Last Update
June 9 2022
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