Actively Recruiting
A Study on the Efficacy and Safety of Oral All-trans Retinoic Acid Combined With Toripalimab in TNBC.
Led by First Affiliated Hospital of Zhejiang University · Updated on 2025-08-12
29
Participants Needed
1
Research Sites
81 weeks
Total Duration
On this page
Sponsors
F
First Affiliated Hospital of Zhejiang University
Lead Sponsor
S
Shanghai Longfine Biotechnology Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
To evaluate the clinical efficacy and safety of oral all-trans retinoic acid in combination with toripalimab in patients with locally advanced, recurrent, or metastatic triple-negative breast cancer who had failed second-line and subsequent therapy.
CONDITIONS
Official Title
A Study on the Efficacy and Safety of Oral All-trans Retinoic Acid Combined With Toripalimab in TNBC.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of informed consent
- Pathologically confirmed triple-negative breast cancer by recent biopsy or pathology
- Unresectable locally advanced or metastatic triple-negative breast cancer after failure of at least second-line standard treatment
- At least one measurable lesion by RECIST 1.1 (excluding only skin or bone lesions)
- Adequate organ and bone marrow function without recent blood transfusions or growth factor treatments
- Willingness to participate, sign informed consent, and comply with study procedures
You will not qualify if you...
- Known symptomatic or uncontrolled brain or central nervous system metastases
- Other malignant tumors except cured basal cell or squamous cell skin cancer or in situ cervical cancer, unless disease-free for 5 years
- Severe or uncontrolled illnesses preventing study participation
- History of immunodeficiency, autoimmune disease, need for high-dose immunosuppressive therapy, or chronic infections
- History of deep vein thrombosis or pulmonary embolism
- Severe osteoporosis or bone metastases
- Recent chemotherapy, immunotherapy, biologic therapy, radiotherapy, traditional Chinese medicine for cancer, or major surgery within specified timeframes before treatment
- Active hepatitis B or C, HIV/AIDS, or positive syphilis antibody test
- History of severe drug allergies or allergy to study drugs
- Investigator's judgment of unsuitability for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The first affiliated hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang Province, P.R. China, China, 310003
Actively Recruiting
Research Team
J
Jian Liu, MS
CONTACT
M
Meihua Lin, MS
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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