NCT06019468

Neoadjuvant Treatment For Locally Advanced Thymic Cancer

Clinical Study of Envolizumab Combined With Radiotherapy for Neoadjuvant Treatment of Locally Advanced Thymic Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Thymic Carcinoma

Interventions

Type	Name	Description
OTHER	Envolizumab combined with radiotherapy	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.

Timeline

• Start date: 2023-09-04
• Primary completion: 2025-08-30
• Completion: 2025-12-30
• First posted: 2023-08-31
• Last updated: 2023-09-06

Locations

1 site across 1 country: China