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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Envolizumab combined with radiotherapy
Other interventionApplication of Envolizumab combined with radiotherapy for neoadjuvant treatment of locally advanced thymic cancer. Firstly, 20-40Gy radiation therapy was administered 10-20 times. Within one week after the start of radiation therapy, Envolizumab (300 mg, D1, Q3W, subcutaneous injection) was administered. Immunotherapy was maintained for 2-4 cycles, and surgery was performed after evaluation by the attending physician.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Neoadjuvant immunotherapy combined with radiotherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
objective response rate（ORR）
ORR was defined as the best overall response (BoR), the proportion of participants in complete and partial response among the number of participants in each treatment group who received at least one medication.
Time frame
24 hourSecondary outcomes
1
Disease control rate（DCR）
DCR is defined as the proportion of imaging findings of CR, PR, and stable disease (SD) in all subjects evaluated according to RECIST V1.1 after completing neoadjuvant immunotherapy combined with radiotherapy
Time frame
24 hours2
Radical resection rate（R0）
Pathological evaluation of the tumor margin, and based on whether the margin is gross or microscopic positive, it is divided into radical resection (R0), microscopic residual lesion (R1), or gross residual lesion (R2)
Time frame
24 hours3
Pathological remission rate
Conduct pathological evaluation based on postoperative specimens to evaluate the percentage of surviving tumor cells, necrosis, and interstitial components in the original tumor bed area.
Time frame
7 days4
disease-free survival（DFS）
The time interval between receiving surgical treatment and tumor recurrence or death due to tumor progression
Time frame
5 yearsSponsors and contacts
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Source ClinicalTrials.gov