Actively Recruiting
A Study of the Efficacy and Safety of Camrelizumab Plus Radiotherapy for Patients With Early Triple-Negative Breast
Led by Jiangxi Provincial Cancer Hospital · Updated on 2020-07-22
20
Participants Needed
1
Research Sites
324 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a open-labeled, single-arm, Investigator-initiated clinical trial of camrelizumab (an anti-PD-1 antibody) in combination with radiotherapy in patients with early triple-negative breast cancer. We will enroll 60 subjects. This study aims to evaluate the efficacy and safety of camrelizumab combined with radiotherapy in the treatment of early TNBC。
CONDITIONS
Official Title
A Study of the Efficacy and Safety of Camrelizumab Plus Radiotherapy for Patients With Early Triple-Negative Breast
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female participants aged 18 years and under 75 years
- Histological or cytological diagnosis of triple-negative breast cancer defined by ER <1%, PR <1%, and HER2 negative
- Gene testing for TNBC subtypes, PD-L1 expression, and tumor mutational burden
- Planned breast-conserving therapy after mastectomy with specific tumor and lymph node involvement criteria
- Adequate organ function including specific blood counts, liver and kidney function limits
- Normal 12-lead ECG with corrected QT interval < 470 ms
- Negative pregnancy test for women of childbearing potential and agreement to use effective contraception during and 90 days after study
- Ability to provide written informed consent and comply with study requirements
You will not qualify if you...
- Known additional progressing malignancy requiring active treatment (except certain skin and carcinoma in situ cases)
- Presence of metastatic lesions at diagnosis
- Prior therapy with anti-PD-1 or anti-PD-L1 antibodies or history of severe allergic reactions to such therapies
- Active autoimmune diseases or recent systemic treatment for autoimmune conditions within 2 years
- Ascites or pleural effusion requiring drainage
- Uncontrolled cardiac conditions including heart failure above NYHA Class I, unstable angina, recent myocardial infarction, or significant arrhythmias
- Abnormal coagulation with bleeding tendency or on anticoagulant treatment
- History of recent serious bleeding or thromboembolism
- Active infection or unexplained fever above 38.5 °C at screening
- Recent gastrointestinal fistula, perforation, or abscess within 4 weeks
- History or evidence of pneumonitis or related lung conditions
- Immunodeficiency or active hepatitis infections
- Participation in other clinical trials within 1 month or receiving other systemic anti-tumor treatments during the study
- Live vaccine received within 4 weeks before or during study
- Psychiatric or substance abuse disorders interfering with study compliance
- Other serious diseases or social/psychological issues deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chunling Jiang
Nanchang, Jiangxi, China
Actively Recruiting
Research Team
C
Chunling Jiang
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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