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.
For patients with locally advanced thymic carcinoma, it is often difficult to perform radical resection. Numerous studies have reported that neoadjuvant therapy can improve the surgical resection rate of thymic tumors by reducing the extent of tumor invasion and eliminating small metastatic lesions, thereby improving patient survival. However, the efficacy of neoadjuvant immunotherapy combined with chemotherapy is limited. This study intends to conduct a single-arm, phase II clinical trial of neoadjuvant immunotherapy combined with radiotherapy for locally advanced thymic carcinoma to verify the feasibility and safety of neoadjuvant immunotherapy combined with radiotherapy. Meanwhile, the investigators evaluate the pathological remission of postoperative specimens to provide recommendations for establishing pathological evaluation criteria for neoadjuvant therapy for thymic carcinoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Application 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.
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGobjective 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 hour
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 hours
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 hours
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 days
disease-free survival(DFS)
The time interval between receiving surgical treatment and tumor recurrence or death due to tumor progression
Time frame: 5 years
overall survival(OS)
The time interval between receiving surgical treatment and the patient's death due to any reason, and the patient is still alive during the final follow-up, with the survival time ending at the last follow-up.
Time frame: 5 years
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