Last updated: September 3, 2023
Sponsor: Shanghai Pulmonary Hospital, Shanghai, China
Overall Status: Active - Recruiting
Phase
2
Condition
Head And Neck Cancer
Carcinoma
Thymomas
Treatment
Envolizumab combined with radiotherapy
Clinical Study ID
NCT06019468
STAR005
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Pathologically confirmed as thymic carcinoma;
- Clinical staging III-IVA (TNM staging system), non-myasthenia gravis (MG) patients,expected to undergo surgical resection;
- On the day when the subject signs the informed consent form, they are ≥ 18 years oldand<75 years old, regardless of gender;
- The subjects are able to understand the informed consent form, voluntarilyparticipate, and sign the informed consent form;
- Subjects who have not received any anti-thymic tumor treatment in the past, includingbut not limited to systemic chemotherapy, radiotherapy, or immunotherapy (only thosewho have received traditional Chinese medicine treatment for anti-tumor indicationsare allowed to be included, and a cleaning period of at least 2 weeks is required);
- At least 1 measurable lesion (according to the solid tumor efficacy evaluationstandard RECIST V1.1);
- Physical fitness score of 0 or 1 (ECOG scoring system of the Eastern CancerCollaborative Group in the United States);
- Female subjects with fertility must have a negative serum pregnancy test within 7 daysbefore the first administration;
- Female subjects with fertility or male subjects with partners with fertility agree touse efficient contraceptive measures (with an annual failure rate of less than 1%)from 7 days before the first administration until 24 weeks after the end ofadministration;
- The main organ functions within 7 days before the first administration meet thefollowing standards:
- Bone marrow function: hemoglobin ≥ 10.0 g/dL (no blood transfusion receivedwithin 28 days before hemoglobin test), absolute neutrophil count ≥ 1.5 × 109/L,platelet count ≥ 100 × 109/L (no platelet transfusion or IL-11 treatment receivedwithin 14 days prior to platelet count test);
- Coagulation function: INR and PT<1.5 × ULN, APTT ≤ 1.5 × ULN;
- Liver function: transaminases (ALT and AST) ≤ 2.5 × ULN; Total bilirubin ≤ 1.5 ×ULN (total bilirubin ≤ 2.5 in subjects with Gilbert's syndrome or livermetastasis) × ULN);
- Renal function: serum creatinine clearance rate ≥ 60 mL/min (calculated accordingto Cockcroft Fault formula);
- Adequate lung function: According to the doctor's judgment, lung function canmeet the requirements of thymectomy surgery.
Exclusion
Exclusion Criteria:
- Pathologically confirmed as a thymic neuroendocrine tumor;
- Subjects who have undergone major surgical treatment (such as abdominal or thoracicsurgery; excluding diagnostic puncture or peripheral vascular pathway replacementsurgery) or have not recovered from surgical treatment within 28 days before theadministration of this trial;
- Within 14 days before the first administration of this study, systemic corticosteroids (≥ 10 mg/day prednisone, or equivalent amounts of other corticosteroids) orimmunosuppressive therapy are required for 7 consecutive days; Excluding inhalation orlocal application of hormones, or receiving physiological replacement doses of hormonetherapy due to adrenal insufficiency; Allow short-term (<7 days) use ofcorticosteroids for prevention (such as contrast agent allergies) or treatment ofnon-autoimmune diseases (such as delayed hypersensitivity reactions caused by exposureto allergens);
- Received live vaccines (including attenuated live vaccines) within 28 days prior toadministration in this study;
- Previously or currently suffering from interstitial pneumonia/lung disease thatrequires systemic hormone therapy;
- Previously or currently suffering from autoimmune diseases, including but not limitedto Crohn's disease, ulcerative colitis, systemic lupus erythematosus, sarcoidosis,Wegener syndrome (granulomatosis of vasculitis, Graves disease, rheumatoid arthritis,pituitary inflammation, uveitis), autoimmune hepatitis, systemic sclerosis (scleroderma, etc.), Hashimoto's thyroiditis (exceptions see below), autoimmunevasculitis Autoimmune neuropathy (Guillain Barre syndrome), etc. The following casesare excluded: type I diabetes, hypothyroidism with stable hormone replacement therapy (including hypothyroidism caused by autoimmune thyroid disease), psoriasis or vitiligowithout systemic treatment;
- Other malignant tumors were combined within 5 years before the first administration,excluding cured skin squamous cell carcinoma, basal cell carcinoma, non-muscleinvasive bladder cancer, localized low-risk prostate (defined as stage ≤ T2a, Gleasonscore ≤ 6, and PSA ≤ 10ng/mL at the time of diagnosis of prostate cancer (if measured,patients who have received radical treatment and have no PSA biochemical relapse canparticipate in this study), and in situ cervical/breast cancer;
- Have uncontrolled heart, kidney, gastrointestinal tract, infectious diseases and othercomplications;
- Previous history of allogeneic bone marrow or organ transplantation;;
- Previously treated with any antibody/drug (immune checkpoint) targeting T cellco-regulatory proteins, such as anti PD (L) 1, CTLA-4, 4-1BB, LAG 3, TIM 3, or antiCD127; Previously received anti-tumor vaccine treatment
- Previous history of allergic reactions to antibody-based drugs and intolerance (≥Level 3 NCI-CTCAE V5.0); Any past history of rapid allergic reactions anduncontrollable asthma (i.e. uncontrollable asthma symptoms of 3 or more of the 3 ormore characteristics of partially controlled asthma); Previous obvious allergies todrugs (such as severe allergic reactions, immune-mediated hepatotoxicity,immune-mediated thrombocytopenia or anemia);
- Pregnant and/or lactating women;
- Other situations that may affect the safety or compliance of drug treatment in thisstudy, including but not limited to mental illness, uncontrolled large amounts ofserous fluid accumulation, or subjects who require repeated drainage (recurrencewithin 2 weeks after intervention) with moderate to large amounts of serous fluidaccumulation, cachexia, etc.
Study Design
Total Participants: 25
Treatment Group(s): 1
Primary Treatment: Envolizumab combined with radiotherapy
Phase: 2
Study Start date:
September 04, 2023
Estimated Completion Date:
December 30, 2025
Study Description
Connect with a study center
Shanghai Pulmonary Hospital
Shanghai, Shanghai
ChinaActive - Recruiting
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