NCT07471815进行中（未招募）2 期
Mechanisms and Efficacy of Camrelizumab Plus Risedronate and Chemotherapy in Triple-Negative Breast Cancer: An Exploratory Clinical Study
Harbin Medical University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年3月4日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
Treatment of triple-negative breast cancer (TNBC) remains a significant challenge. Although immune checkpoint inhibitors combined with chemotherapy have achieved breakthroughs, drug resistance persists, leaving clinical needs unmet. Bisphosphonates target the FDPS/mevalonate pathway, not only directly inhibiting tumors but also remodeling the immune microenvironment, positioning them as a potential strategy to reverse immune resistance. Therefore, this exploratory study of camrelizumab combined with risedronate sodium and chemotherapy aims to generate synergistic anti-tumor effects through the dual action of immune checkpoint blockade and metabolic-immune microenvironment remodeling. The goal is to overcome resistance, improve the objective response rate, and ultimately enhance the long-term survival prognosis for patients with TNBC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged ≥ 18 years and ≤ 70 years.
- •Histopathologically confirmed triple-negative breast cancer: Immunohistochemistry (IHC) shows estrogen receptor (ER) and progesterone receptor (PR) are both negative (i.e., positively stained tumor cells account for <10% of all tumor cells); IHC shows HER2 negative: test result is 0/1+; if the test result is 2+, in situ hybridization (ISH) must show a HER2/CEP17 ratio < 2.0 or HER2 gene copy number <
- •Presence of measurable tumor lesions (meeting RECIST 1.1 criteria).
- •ECOG performance status score of 0-
- •Life expectancy of no less than 3 months.
- •Adequate major organ function meeting the following criteria (no blood transfusions, no use of leukocyte- or platelet-raising drugs within 2 weeks prior to screening):
- •(1) Hematology requirements: ANC ≥ 1.5 × 10⁹/L; PLT ≥ 90 × 10⁹/L; Hb ≥ 90 g/L. (2) Biochemistry requirements: TBIL ≤ 1.5 × upper limit of normal (ULN); ALT and AST ≤ 1.5 × ULN; Alkaline phosphatase ≤ 2.5 × ULN; BUN and Cr ≤ 1.5 × ULN and creatinine clearance ≥ 50 mL/min (by Cockcroft-Gault formula).
- •(3) Thyroid-stimulating hormone (TSH) ≤ ULN (if abnormal, T3 and T4 levels should be checked; patients with normal T3 and T4 levels can be enrolled).
- •(4) Cardiac color Doppler ultrasound and echocardiography: Left ventricular ejection fraction (LVEF) ≥ 50%.
- •(5) 18-lead ECG: Fridericia-corrected QT interval (QTcF) < 480 ms for females.
- •7.Women of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days before enrollment and voluntarily agree to use adequate contraception during the observation period and for 4 months after the last dose of the study drug.
- •8.Voluntary participation, signed informed consent, and good compliance.
排除标准
- •Concurrently receiving anti-tumor therapy in another clinical trial.
- •Received other anti-tumor therapy within 14 days prior to the first dose.
- •Underwent major surgery unrelated to breast cancer within 4 weeks before enrollment, or has not fully recovered from such surgery.
- •Patients with any active autoimmune disease or a history of autoimmune disease (such as, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; patients with vitiligo or childhood asthma that has completely resolved and requires no intervention in adulthood may be included; patients requiring bronchodilators for asthma management cannot be included).
- •Severe cardiac disease or discomfort, including but not limited to: history of heart failure or systolic dysfunction (LVEF < 50%); high-risk uncontrolled arrhythmias, such as atrial tachycardia, resting heart rate > 100 bpm, significant ventricular arrhythmias (e.g., ventricular tachycardia), or higher-degree atrioventricular block (i.e., Mobitz II second-degree or third-degree AV block); angina requiring anti-anginal medication; clinically significant valvular heart disease; ECG evidence of transmural myocardial infarction; poorly controlled hypertension (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg).
- •Patients with congenital or acquired immunodeficiency (e.g., HIV infection).
- •Received a live vaccine within 4 weeks prior to study medication or plans to receive one during the study.
- •Inability to swallow tablets, malabsorption syndrome, or any condition affecting gastrointestinal absorption.
- •Known history of allergy to any component of the study drugs in this protocol.
- •Patients with hypocalcemia.
- •Patients unable to maintain a standing or sitting upright position for 30 minutes.
- •Presence of severe concomitant diseases or other comorbidities that would interfere with the planned treatment, or any other condition deemed by the investigator to make the patient unsuitable for participation in this study.
研究组 & 干预措施
Treatment Group
Experimental
Camrelizumab + Risedronate Sodium + Chemotherapy
干预措施: Camrelizumab + Risedronate Sodium + Chemotherapy (Drug)
结局指标
主要结局
ORR
时间窗: At the end of every 2 Cycles (each cycle is 21 days), From first treatment Cycle until achieving complete response (CR) or response (PR) per RECIST v1.1, assessed up to 1 year, defined as the proportion of patients achieving complete response
Objective Response Rate
次要结局
- Incidence of adverse events of any grade(Safety follow-up will be conducted from the first dose until the end of treatment. Adverse events occurring during this period will be recorded, with a maximum assessment period of 2 years.)
- OS(Refers to the time from randomization to death due to any cause, with a maximum assessment period of 2 years.)
- 6-PFS Rate(The proportion of patients who have not experienced tumor progression or death from any cause by 6 months from the start of first treatment, with a maximum assessment period of 6 months.)
- DOR(Refers to the time from the first assessment of CR or PR to the first assessment of disease progression (PD) or death from any cause. The assessment period is up to 2 years.)
- DCR(Patients undergo imaging evaluation in every 2 cycles（each cycyle is 21 days）until achieving SD per RECIST v1.1 or through study completion, assessed up to 1 year.)
- Incidence of new bone metastases(Starting from the first dose, regular imaging follow-ups will be conducted to monitor for the occurrence of bone metastases, continuing until 2 years.)
- BMD(A key indicator for measuring bone strength, reflecting the mineral content (mainly calcium, phosphorus, etc.) per unit volume or unit area of bone. Assessments will be conducted once every three months for up to 2 year.)
研究者
Tong Liu
Professor
Harbin Medical University
研究点 (1)
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