Neoadjuvant Treatment For Locally Advanced Thymic Cancer (NCT06019468) | Clinical Trial Compass
RecruitingPhase 2
Neoadjuvant Treatment For Locally Advanced Thymic Cancer
China25 participantsStarted 2023-11-04
Plain-language summary
The aims of this study are to verify the feasibility, effectiveness, and safety of the combination of enrolizumab and radiotherapy for neoadjuvant treatment for locally advanced thymic carcinoma, and to provide recommendations for the establishment of unified evaluation criteria for the neoadjuvant therapy of thymic cancer by evaluating the pathological remission status of thymic cancer specimens after neoadjuvant treatment.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Pathologically confirmed as thymic carcinoma;
✓. On the day when the subject signs the informed consent form, they are ≥ 18 years old and\<75 years old, regardless of gender;
✓. The subjects are able to understand the informed consent form, voluntarily participate, and sign the informed consent form;
✓. Subjects who have not received any anti-thymic tumor treatment in the past, including but not limited to systemic chemotherapy, radiotherapy, or immunotherapy (only those who have received traditional Chinese medicine treatment for anti-tumor indications are 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 evaluation standard RECIST V1.1);
✓. Physical fitness score of 0 or 1 (ECOG scoring system of the Eastern Cancer Collaborative Group in the United States);
✓. Female subjects with fertility must have a negative serum pregnancy test within 7 days before the first administration;
Exclusion criteria
✕. Pathologically confirmed as a thymic neuroendocrine tumor;
✕. Subjects who have undergone major surgical treatment (such as abdominal or thoracic surgery; excluding diagnostic puncture or peripheral vascular pathway replacement surgery) or have not recovered from surgical treatment within 28 days before the administration of this trial;
What they're measuring
1
objective response rate（ORR）
Timeframe: 24 hour
Trial details
NCT IDNCT06019468
SponsorShanghai Pulmonary Hospital, Shanghai, China
✕. Within 14 days before the first administration of this study, systemic corticosteroids (≥ 10 mg/day prednisone, or equivalent amounts of other corticosteroids) or immunosuppressive therapy are required for 7 consecutive days; Excluding inhalation or local application of hormones, or receiving physiological replacement doses of hormone therapy due to adrenal insufficiency; Allow short-term (\<7 days) use of corticosteroids for prevention (such as contrast agent allergies) or treatment of non-autoimmune diseases (such as delayed hypersensitivity reactions caused by exposure to allergens);
✕. Received live vaccines (including attenuated live vaccines) within 28 days prior to administration in this study;
✕. Previously or currently suffering from interstitial pneumonia/lung disease that requires systemic hormone therapy;
✕. Previously or currently suffering from autoimmune diseases, including but not limited to 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), autoimmune vasculitis Autoimmune neuropathy (Guillain Barre syndrome), etc. The following cases are excluded: type I diabetes, hypothyroidism with stable hormone replacement therapy (including hypothyroidism caused by autoimmune thyroid disease), psoriasis or vitiligo without systemic treatment;
✕. Other malignant tumors were combined within 5 years before the first administration, excluding cured skin squamous cell carcinoma, basal cell carcinoma, non-muscle invasive bladder cancer, localized low-risk prostate (defined as stage ≤ T2a, Gleason score ≤ 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 can participate in this study), and in situ cervical/breast cancer;
✕. Have uncontrolled heart, kidney, gastrointestinal tract, infectious diseases and other complications;