Neoadjuvant Treatment For Locally Advanced Thymic Cancer
ConditionThymic Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Pulmonary Hospital, Shanghai, China
About this trial
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.
Eligibility criteria
Qualifiers
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 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;
Disqualifiers
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;
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;
Trial design
Treatments tested in this trial
- Envolizumab combined with radiotherapy
Treatment groups
25 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov