Actively Recruiting
QL1706 Plus Chemotherapy +/- Bevacizumab in 1L Treatment of R/mTNBC
Led by Fudan University · Updated on 2025-02-06
60
Participants Needed
1
Research Sites
220 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is to evaluate the efficacy and safety of QL1706 plus albumin-bound paclitaxel ± bevacizumab in 1L treatment of r/mTNBC
CONDITIONS
Official Title
QL1706 Plus Chemotherapy +/- Bevacizumab in 1L Treatment of R/mTNBC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 70 years
- Histologically confirmed breast cancer that is estrogen receptor negative, progesterone receptor negative, and HER2 negative according to ASCO/CAP guidelines
- Locally advanced, recurrent, or metastatic breast cancer without prior systemic treatment for this stage (adjuvant/neoadjuvant treatment allowed if recurrence/metastasis occurred at least 6 months after last treatment)
- At least one measurable lesion per RECIST 1.1
- ECOG performance status of 0 or 1
- Availability of tumor tissue specimens for biomarker detection
- Adequate organ function defined by specific laboratory values and no blood components or growth factor drugs within 14 days before first medication
You will not qualify if you...
- Active autoimmune disease or history of autoimmune disease, including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism (vitiligo or childhood asthma fully resolved and not requiring treatment allowed; asthma needing bronchodilator treatment excluded)
- Current use of immunosuppressants or systemic steroid therapy exceeding 10 mg daily prednisone equivalent within 2 weeks before enrollment
- Severe allergic reactions to monoclonal antibodies
- Known interstitial lung disease or active non-infectious pneumonia
- Known central nervous system metastasis
- History of other malignant tumors within past 5 years except cured basal cell carcinoma or cervical cancer in situ
- Uncontrolled hypertension or hypertensive crisis (controlled hypertension allowed)
- Severe cardiovascular or cerebrovascular diseases including heart failure NYHA grade 2+, unstable angina, recent myocardial infarction, serious arrhythmias, prolonged QTc
- Receiving thrombolysis or anticoagulation therapy (except prophylactic low-dose aspirin or low-molecular-weight heparin)
- Significant bleeding symptoms or bleeding tendency within 3 months before enrollment
- Tumor invasion of vital blood vessels with risk of fatal bleeding
- Pleural effusion, ascites, or pericardial effusion requiring drainage unless stable after drainage
- Arterial/venous thrombosis events within 6 months before enrollment
- Major vascular disease requiring recent surgical repair within 6 months
- Urine protein ≥ ++ and confirmed 24-hour urine protein >1.0 g
- Active infection, unexplained fever ≥ 38.5°C within 7 days before treatment, or high baseline white blood cell count
- Congenital or acquired immune deficiency including HIV, active hepatitis B or C infection
- Recent live vaccine within 4 weeks before or planned during study
- Other factors affecting study results or patient safety such as alcoholism, drug abuse, serious diseases including mental illness, or severe laboratory abnormalities
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
W
Wang Hongxia
CONTACT
T
Tao Zhonghua
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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