Actively Recruiting
Tislelizumab Combined With Anlotinib as Second-line Therapy in Thymoma and Thymic Carcinoma
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2025-12-01
20
Participants Needed
1
Research Sites
91 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
It is an open-lable, single-arm, single-center, phase II clinical trial conducted in China, and plan to recruiting 20 patients who were progressed after first line chemotherapy or chemotherapy combined with immunotherapy. The purpose of this study is to evaluate the safety and efficacy of tislelizumab combined with anlotinib as second-line in thymoma and thymic carcinoma.
CONDITIONS
Official Title
Tislelizumab Combined With Anlotinib as Second-line Therapy in Thymoma and Thymic Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years old, no gender restriction
- Histologically or cytologically confirmed thymoma or thymic carcinoma
- Disease progression during or after first-line chemotherapy, with or without immunotherapy
- At least one measurable solid tumor lesion according to RECIST 1.1 criteria
- Estimated survival of at least 3 months and ECOG performance status of 0 or 1
- Adequate vital organ function including neutrophil count 21.5�D7109/L, platelet count 2100�D7109/L, hemoglobin 280g/L, bilirubin 21.5�D7 upper limit of normal, ALT and AST 2.5�D7 upper limit of normal, serum albumin 28g/L, and left ventricular ejection fraction 250%
- Female participants of childbearing potential must have a negative pregnancy test within 7 days prior to first dose and be non-lactating
- Participants of childbearing potential must agree to use contraception during the study and for 8 weeks after the last treatment
- Signed informed consent form
You will not qualify if you...
- Prior treatment with anlotinib or any other anti-angiogenesis drugs
- Symptomatic brain metastasis
- Other primary malignancy within the past 5 years, except for radical non-melanoma skin cancer or cured cervical in-situ carcinoma
- Active, known, or suspected autoimmune diseases such as interstitial pneumonia, uveitis, Crohn's disease, or autoimmune thyroiditis
- Severe infections within 4 weeks prior to enrollment
- Severe acute comorbidities including uncontrolled pleural/pericardial effusion or ascites, unstable angina or myocardial infarction within 12 months, uncontrolled congestive heart failure, uncontrollable hypertension, or significant proteinuria
- Tumor invading vital vessels with high risk of fatal hemorrhage during follow-up
- Clinically significant hemoptysis greater than 50 ml daily within 3 months prior to enrollment or significant bleeding tendencies
- Major surgery, incisional biopsy, or significant traumatic injury within 28 days prior to enrollment
- Mental illness or drug abuse interfering with compliance
- Known allergy to monoclonal antibodies
- Systemic steroid therapy within 2 weeks prior to first dose or other immunosuppressive medication
- Diagnosis of immunodeficiency or ongoing immunosuppressive therapy within 2 weeks prior to first dose
- Participation in another clinical trial within 28 days
- Any condition interfering with safety evaluation or study results per investigator's judgment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210000
Actively Recruiting
Research Team
W
Wen Gao
CONTACT
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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