Actively Recruiting
Phase II, Single-arm Exploratory Clinical Study of Tislelizumab Combined With Anlotinib in the Treatment of Advanced Pulmonary Pleomorphic Carcinoma
Led by Second Affiliated Hospital of Nanchang University · Updated on 2025-06-11
32
Participants Needed
1
Research Sites
280 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Evaluate the efficacy and safety of tislelizumab in combination with anlotinib in patients with stage III and IV PSC .
CONDITIONS
Official Title
Phase II, Single-arm Exploratory Clinical Study of Tislelizumab Combined With Anlotinib in the Treatment of Advanced Pulmonary Pleomorphic Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent
- Male or female aged 18 to 80 years
- Diagnosed with stage III or IV pulmonary sarcomatoid carcinoma confirmed by tissue or cell analysis
- Tumor is inoperable or intolerant to radiotherapy with at least one measurable lesion
- Negative for EGFR and ALK driver genes
- Have had two or fewer previous systemic anti-tumor treatments
- ECOG performance score of 0 or 1
- Life expectancy of at least 12 weeks
- Normal main organ function meeting blood, biochemical, kidney, and heart function criteria
- Women of childbearing age must use reliable contraception and have a negative pregnancy test before enrollment
- Men must agree to use contraception or have been surgically sterilized during the study and for 8 weeks after last treatment
You will not qualify if you...
- Previous treatment with immune checkpoint inhibitors such as anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies
- Use of systemic immunomodulators within 4 weeks before study or within 5 half-lives of the drug
- Presence of obvious pulmonary cavernous tumor on imaging
- Symptomatic brain metastasis, cancerous meningitis, spinal cord compression, or brain diseases unless stable after treatment
- Participation in other clinical studies or less than 4 weeks since last study treatment
- Other cancers within past 2 years except certain cured or superficial tumors
- Active or suspected autoimmune disease, history of organ or stem cell transplantation, or HIV/AIDS
- Need for systemic corticosteroids or immunosuppressants during first 14 days of treatment
- Unresolved side effects from prior anti-tumor therapy greater than grade 1 except hair loss
- Serious cardiovascular diseases or heart function below normal limits
- History of interstitial lung disease, pneumonia, uncontrolled systemic diseases, or active lung infections
- Known severe allergy to monoclonal antibodies
- History of psychotropic drug, alcohol, or drug abuse
- Active, uncontrolled hepatitis B or C infections
- Any other serious conditions that may affect safety or study participation as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Second Afiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Actively Recruiting
Research Team
A
Anwen Liu, Phd
CONTACT
Z
Zhimin Zeng
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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