Actively Recruiting
Tislelizumab Combined With Anlotinib as Second-line Therapy in Thymoma and Thymic Carcinoma: An Open-label, Single-centre, Phase 2 Study
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2025-12-01
20
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of combining tislelizumab with anlotinib as a second-line treatment for patients with thymoma and thymic carcinoma who have experienced disease progression after first-line chemotherapy or chemotherapy combined with immunotherapy. This open-label, single-arm, phase II clinical trial conducted in China plans to recruit 20 patients. The study aims to better understand treatment options for this condition. All participants will receive tislelizumab 200 mg on Day 1 every 3 weeks along with anlotinib given at doses of 12 mg, 10 mg, or 8 mg daily from Day 1 to Day 14 every 3 weeks. Treatment continues until the disease progresses. This study does not include a comparison group and focuses on this combined drug regimen as the experimental intervention. Participants will be monitored for up to two years after enrollment to assess the objective response rate, overall survival, progression-free survival, and duration of response. Assessments include tumor measurement according to RECIST 1.1 criteria, vital organ function tests, and safety evaluations. The study includes regular follow-up visits and requires participants to meet specific health and organ function criteria before joining.
CONDITIONS
Brief 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, any gender
- 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 score of 0 or 1
- Vital organ function meets specific blood counts, liver function, and heart function criteria
- Female subjects of childbearing potential must have a negative pregnancy test and be non-lactating
- Agreement to comply with contraceptive requirements during and for 8 weeks after treatment
- Signed informed consent form
You will not qualify if you...
- Prior treatment with anlotinib or other anti-angiogenesis drugs
- Symptomatic brain metastasis
- Other primary malignancy within the past 5 years except certain cured cancers
- Active, known or suspected autoimmune disease
- Severe infections within 4 weeks before inclusion
- Severe acute comorbidities such as uncontrolled effusions, unstable heart conditions, or uncontrolled hypertension
- Significant tumor invasion of vital vessels with high risk of fatal hemorrhage
- Clinically significant bleeding or bleeding tendency within 3 months before enrollment
- Major surgery, biopsy, or significant injury within 28 days before inclusion
- Mental illness or drug abuse that interferes with compliance
- Known allergy to monoclonal antibodies
- Recent systemic steroid or immunosuppressive therapy within 2 weeks prior to first treatment
- Immunodeficiency or ongoing immunosuppressive therapy
- Participation in another clinical trial within 28 days
- Any condition interfering with safety evaluation or study results
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.
Duration - Until disease progression
Participants receive tislelizumab 200mg on Day 1 every 3 weeks plus anlotinib 8mg, 10mg, or 12mg on Days 1-14 every 3 weeks until disease progression.
Visits every 3 weeks for treatment administration
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
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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