Actively Recruiting
Clinical Study of Envolizumab Combined With Radiotherapy for Neoadjuvant Treatment of Locally Advanced Thymic Cancer
Led by Shanghai Pulmonary Hospital, Shanghai, China · Updated on 2026-05-08
25
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of Envolizumab and radiotherapy as a neoadjuvant treatment for patients with locally advanced thymic carcinoma. This single-arm, phase II clinical trial aims to confirm the feasibility, safety, and effectiveness of this combination in improving surgical outcomes and to develop unified criteria for assessing pathological remission after neoadjuvant therapy in thymic cancer. The treatment includes delivering 20-40 Gy of radiotherapy over 10-20 sessions. Within one week after starting radiotherapy, patients receive subcutaneous injections of Envolizumab (300 mg) every three weeks for 2 to 4 cycles as maintenance therapy. Surgery is planned after treatment evaluation by the attending physician. Participants will be closely monitored through various assessments including pathological examination of surgical specimens to evaluate remission status. Key outcomes measured include objective response rate, disease control rate, radical resection rate, pathological remission rate, and long-term disease-free and overall survival over five years. Safety and treatment adherence will also be tracked throughout the study period.
CONDITIONS
Brief Title
Neoadjuvant Treatment For Locally Advanced Thymic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed thymic carcinoma
- Clinical stage III-IVA thymic carcinoma, non-myasthenia gravis patients expected to undergo surgery
- Age 18 years or older and under 75 years at consent
- Able to understand and voluntarily sign informed consent
- No prior anti-thymic tumor treatment including chemotherapy, radiotherapy, or immunotherapy (traditional Chinese medicine allowed with 2-week washout)
- At least one measurable lesion per RECIST V1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Negative serum pregnancy test within 7 days before first dose for females with fertility
- Use of effective contraception from 7 days before first dose until 24 weeks after end of treatment for fertile participants
- Adequate organ function including bone marrow, coagulation, liver, kidney, and lung function within 7 days before first dose
You will not qualify if you...
- Thymic neuroendocrine tumor diagnosis
- Recent major surgery within 28 days before treatment or not recovered
- Use of systemic corticosteroids or immunosuppressive therapy 14 days before first dose, except certain exceptions
- Receipt of live vaccines within 28 days before treatment
- Interstitial pneumonia or lung disease requiring systemic hormone therapy
- Autoimmune diseases except specific stable or mild conditions
- Other cancers within 5 years except certain cured or low-risk types
- Uncontrolled heart, kidney, gastrointestinal, infectious diseases, or other complications
- History of allogeneic bone marrow or organ transplant
- Prior treatment with immune checkpoint inhibitors or anti-tumor vaccines
- History of severe allergic reactions or intolerances to antibody drugs
- Pregnancy or breastfeeding
- Other conditions affecting safety or compliance including mental illness, fluid accumulation, or cachexia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of 10 to 20 radiotherapy sessions and 2 to 4 cycles of immunotherapy over several weeks
Participants receive neoadjuvant immunotherapy combined with radiotherapy for locally advanced thymic cancer. Radiotherapy is given in 10 to 20 sessions delivering 20-40Gy, alongside 2 to 4 cycles of Envolizumab immunotherapy administered every 3 weeks by subcutaneous injection.
Multiple visits corresponding to radiotherapy sessions and immunotherapy administration
Duration - Single surgical event occurring after neoadjuvant treatment completion
Participants undergo surgery after evaluation by the attending physician following neoadjuvant treatment.
1 visit for surgery
Trial Site Locations
Total: 1 location
1
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
J
Juemin Yu
D
Deping Zhao, MD,PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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