Actively Recruiting
Tislelizumab Combined With Recombinant Human Endostatin Combined With Chemotherapy for Unresectable Stage III Non-small Cell Lung Cancer.
Led by Hua Zhang · Updated on 2025-07-15
36
Participants Needed
1
Research Sites
158 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, single-arm, multicenter, phase II clinical study designed to evaluate the initial efficacy and safety of patients receiving Tislelizumab in combination with recombinant human endostatin injection plus chemotherapy for stage III unresectable non-small cell lung cancer. To evaluate the surgical conversion rate of tirellizumab combined with recombinant human endostatin injection and chemotherapy induction therapy in patients with initially unresectable stage III non-small cell lung cancer.
CONDITIONS
Official Title
Tislelizumab Combined With Recombinant Human Endostatin Combined With Chemotherapy for Unresectable Stage III Non-small Cell Lung Cancer.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Fully understand the study and voluntarily sign informed consent
- Age between 18 and 75 years, any gender
- Histologically confirmed stage III unresectable squamous or non-squamous non-small cell lung cancer
- At least one measurable lesion by RECIST v1.1
- ECOG performance status score of 0 or 1
- Eligible for platinum-based doublet chemotherapy
- Good organ function including specified blood counts, kidney function, liver function, and coagulation parameters
- Willing and able to comply with study visits, treatment, and tests
- Sufficient lung function to tolerate proposed pneumonectomy
- Negative serum pregnancy test for women of childbearing age before first treatment
- Agreement to use effective contraception during study and for 120 days after last dose
You will not qualify if you...
- Known mutations: EGFR, ALK, ROS-1, RET, HER-2, MET, or unknown driver gene status in non-squamous carcinoma
- Prior treatment for current lung cancer including radiotherapy, chemotherapy, immunotherapy, targeted or antiangiogenic therapy
- Presence of large cell neuroendocrine carcinoma or mixed small cell components
- Use of other systemic immunomodulators within 4 weeks before treatment
- Tumors likely invading major blood vessels with high bleeding risk
- Significant hemoptysis or bleeding tendencies within 3 months before study
- Use of Chinese herbs for cancer control within 14 days before treatment
- Live vaccine received within 30 days before first dose or planned during study
- Need for systemic corticosteroids or immunosuppressants within 14 days before treatment
- Active autoimmune diseases requiring systemic treatment
- Uncontrolled interstitial lung disease, pneumonia, or other uncontrolled diseases
- History of major diseases affecting organ function deemed unsuitable by investigator
- Severe infections requiring systemic treatment within 14 days before treatment
- Active hepatitis B or C infection not adequately controlled
- Known HIV infection
- Severe heart failure or uncontrolled arrhythmias
- Recent arterial thrombosis or embolism within 6 months
- Participation in other therapeutic clinical trials unless observational or in follow-up
- Any other condition or risk judged by investigator to interfere with study participation or safety
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shandong Public Health Clinical Center (ShandongPHCC)
Jinan, Shandong, China, 250000
Actively Recruiting
Research Team
H
Hua Zhang, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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