NCT07676162招募中3 期
A Randomized, Open-label, Controlled, Multicenter Phase III Clinical Study of SHR-A1811 in Combination With mFOLFOX6 (-1) and Bevacizumab Versus mFOLFOX6 in Combination With Bevacizumab as First-line Treatment for Advanced Colorectal Cancer.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Progression-Free Survival (PFS) assessed by the Independent Review Committee (IRC)
研究概览
简要总结
This study adopts a randomized, open-label, positive-controlled, multicenter design, aiming to evaluate the efficacy and safety of SHR-A1811 in combination with chemotherapy and bevacizumab versus standard therapy as first-line treatment for advanced colorectal cancer, and to explore the drug's immunogenicity and pharmacokinetic characteristics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects voluntarily enroll in the study, sign informed consent, demonstrate good compliance and cooperate with follow-up visits.
- •Aged between 18 and 75 years inclusive, male or female.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Estimated survival expectancy ≥ 12 weeks.
- •Histologically or cytologically confirmed colorectal adenocarcinoma.
- •No prior systemic anti-tumor therapy.
- •Tumor tissue specimen must be provided, either archived within 1 year prior to first study treatment or newly collected fresh specimen.
- •At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1; the measurable lesion shall not have received prior local therapy such as radiotherapy.
- •Adequate organ function with relevant laboratory tests completed within 7 days before the first study treatment.
- •Male subjects with fertile female partners and fertile female subjects must use highly effective contraception throughout the study. Fertile female subjects must have a negative serum or urine human chorionic gonadotropin (HCG) test within 7 days prior to first study drug administration and shall not be breastfeeding.
排除标准
- •Received systemic anti-tumor therapies (including investigational agents) or major surgery within 4 weeks prior to the first study drug administration; palliative radiotherapy within 2 weeks or surgery within 4 weeks before study treatment initiation.
- •History of hypersensitivity to monoclonal antibodies or any component of the investigational products to be administered in this study.
- •Pre-existing peripheral neuropathy of Grade >
- •History of thromboembolic disease within 6 months or hemoptysis within 3 months before first study medication. Subjects with muscular venous thrombosis not requiring anticoagulation per investigator's assessment are eligible for enrollment.
- •CT/MRI evidence of tumor encasement or invasion of major blood vessels.
- •Non-gastrointestinal bleeding within 6 months prior to first study drug administration, or active peptic ulcer disease.
- •Uncontrolled hypertension, or medical history of hypertensive crisis or hypertensive encephalopathy.
- •History of severe cerebrovascular disease.
- •Unresolved toxicities and/or complications from prior interventions that have not recovered to baseline.
- •Subjects with a history of or current leptomeningeal metastases, or active brain metastases.
- •Known or suspected interstitial lung disease (ILD); moderate-to-severe pulmonary disease significantly impairing respiratory function or autoimmune/connective tissue/inflammatory diseases involving the lung within 3 months before first dosing that may interfere with detection or management of drug-related pulmonary toxicity. Subjects who developed ≥Grade 3 ILD during prior immune checkpoint inhibitor treatment are excluded.
- •Symptomatic moderate to severe ascites; uncontrolled moderate or greater pleural or pericardial effusion.
- •Bowel obstruction within 3 months prior to first study treatment, or prior intestinal stent placement with the stent remaining in situ at screening.
- •Uncontrolled or severe cardiovascular disease, or unstable angina/unstable arrhythmia occurring within 1 month before initiation of study treatment.
- •Unexplained fever >38.5°C at screening or prior to first dose; severe infection (CTCAE Grade >2) within 4 weeks before study drug initiation; active pulmonary inflammation on baseline chest imaging, or clinical signs/symptoms of infection requiring oral or intravenous antibiotics within 2 weeks before first dosing.
- •Previous or concurrent diagnosis of other malignant malignancies.
- •Active hepatitis B or active hepatitis C infection.
- •History of immunodeficiency including positive HIV test, congenital/acquired immunodeficiency disorders, or prior solid organ transplantation.
- •Active pulmonary tuberculosis infection within 1 year prior to screening, or prior active pulmonary tuberculosis without standard anti-tuberculosis treatment even if diagnosed more than 1 year ago.
- •Pregnant, breastfeeding females or females planning pregnancy during the study period.
- •Uncontrolled psychiatric disorders, known alcohol abuse, illicit drug dependence, incarceration or other conditions that would preclude completion of study procedures.
- •Any other conditions deemed inappropriate for study participation by the investigator, including clinically significant abnormal laboratory values, familial/social factors or other risks leading to premature study discontinuation or confounding study results.
研究组 & 干预措施
Treatment group A
Experimental
SHR-A1811 in combination with Oxaliplatin, Levo-leucovorin, Fluorouracil and Bevacizumab
干预措施: SHR-A1811, Oxaliplatin, Levo-leucovorin, Fluorouracil and Bevacizumab (Drug)
Treatment group B
Active Comparator
Standard First-line treatment
干预措施: Oxaliplatin, Levo-leucovorin, Fluorouracil and Bevacizumab (Drug)
结局指标
主要结局
Progression-Free Survival (PFS) assessed by the Independent Review Committee (IRC)
时间窗: From the first dose to the last visit, approximately11 months
次要结局
- Overall Survival (OS)(From the first dose to the last visit, approximately 11 months)
- Objective Response Rate (ORR) assessed by Independent Review Committee (IRC)(From the first dose to the last visit, approximately 11months)
- Duration of Response (DoR) assessed by Independent Review Committee (IRC)(From the first dose to the last visit, approximately 11months)
- Progression-Free Survival (PFS) assessed by the Investigator(From the first dose to the last visit, approximately11 months)
- Objective Response Rate (ORR) assessed by the Investigator(From the first dose to the last visit, approximately 11 months)
- Duration of Response (DoR) assessed by the Investigator(From the first dose to the last visit, approximately 11 months)
- Incidence and severity of Adverse Events (AEs).(From the first dose to the last visit, approximately11 months)
- Anti-SHR-A1811 Antibodies (ADA)(From the first dose to the last visit, approximately 11 months)
- Plasma concentrations of toxin-conjugated antibody of SHR-A1811(From the first dose to the last visit, approximately 11 months)
研究者
研究点 (2)
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