NCT07779538尚未招募3 期
A Randomized, Open-label, Multicenter Phase Ib/III Clinical Trial Comparing Trastuzumab Plus Bevacizumab With Bevacizumab as First-line Maintenance Therapy for Epithelial Ovarian Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 420
- 试验地点
- 3
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
This trial is a randomized, open-label, positive-controlled, multicenter phase Ib/III clinical trial, divided into two phases. Phase Ib aims to evaluate the safety and tolerability of SHR-A1811 in combination with bevacizumab as first-line maintenance therapy in participants with epithelial ovarian cancer without pathological progression (PD) after first-line platinum-based doublet chemotherapy plus bevacizumab (hereinafter referred to as "platinum-based triple therapy"). Phase III aims to evaluate the efficacy and safety of SHR-A1811 in combination with bevacizumab versus bevacizumab as maintenance therapy in participants with epithelial ovarian cancer without PD after first-line platinum-based triple therapy.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participants voluntarily join this trial and sign an informed consent form.
- •Newly diagnosed stage III or IV epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, confirmed by histological or cytological pathology.
- •Prior to first-line platinum-based doublet chemotherapy combined with bevacizumab.
- •No disease progression as assessed by the investigator after completion of first-line platinum-based therapy and before randomization.
- •Participants' homologous recombination deficiency test results must meet the criteria.
- •Participants have not received any anti-tumor therapy from the last dose of first-line platinum-based therapy until randomization.
- •Able to provide sufficient fresh or archived tumor tissue specimens for testing at the sponsor-designated central laboratory.
- •ECOG PS score: 0-
- •Expected survival ≥ 12 weeks.
- •Laboratory tests within 7 days prior to randomization confirm that important organ function meets the requirements.
- •Female participants of childbearing potential must have a negative serum human chorionic gonadotropin (HCG) test within 7 days prior to randomization and must not be breastfeeding; female participants of childbearing potential must agree to adhere to contraception from the date of signing the informed consent form until 7 months after the last dose.
排除标准
- •Participants with untreated or active central nervous system (CNS) metastases; a history of meningeal metastases or current meningeal metastases.
- •Participants with clinically symptomatic, poorly controlled, or moderate to severe pleural effusion, pericardial effusion, or ascites.
- •Participants with a history of or concurrent other malignancies, excluding cured basal cell carcinoma of the skin, cervical carcinoma in situ, ductal carcinoma in situ of the breast, papillary thyroid carcinoma, and other malignancies that have been adequately treated and cured for ≥5 years prior to randomization with evidence of no recurrence or metastasis.
- •Participants with a history of interstitial pneumonia/interstitial lung disease requiring steroid treatment, non-infectious pneumonia (such as radiation pneumonitis), current or suspected interstitial pneumonia/interstitial lung disease, non-infectious pneumonia, or other active pneumonia; or those with severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, or other lung damage within 6 months prior to randomization.
- •6. Individuals with active pulmonary tuberculosis; those who have received adequate and regular treatment and have stopped anti-tuberculosis treatment for ≥3 months prior to randomization are eligible for enrollment.
- •7. Individuals with poorly controlled or severe cardiovascular disease.
- •Individuals who have experienced arterial/venous thrombotic events within 6 months prior to randomization.
- •9. Individuals who have experienced NCI-CTCAE v6.0 grade ≥2 bleeding events within 1 month prior to randomization.
- •10. Individuals with known hereditary or acquired bleeding (e.g., coagulation disorders) or thrombotic tendency.
- •11. Individuals who have experienced or are expected to experience gastrointestinal perforation or fistula, tracheal fistula, urethral fistula, or abdominal abscess in the near future.
- •12. Individuals with gastrointestinal obstruction or symptoms and signs of gastrointestinal obstruction within 3 months prior to randomization; individuals who have previously undergone intestinal stent implantation and whose intestinal stent has not been removed by the screening period.
- •13. Participants who have experienced severe infection within 1 month prior to randomization.
- •14. Participants who have tested positive for human immunodeficiency virus (HIV); participants with known active hepatitis.
- •15. Participants who have undergone major surgery within 4 weeks prior to randomization or whose surgical side effects have not recovered or stabilized prior to randomization.
- •Patients who may receive other systemic anti-tumor therapies during treatment or are scheduled for further debulking surgery.
- •17. Patients whose toxicity from previous anti-tumor therapy has not recovered to grade ≤1 according to the NCI-CTCAE v6.0 classification.
- •18. Patients with known hypersensitivity to any component of the SHR-A1811 product or other monoclonal antibody drugs.
- •19. Patients who, in the investigator's judgment, have other factors that may affect the trial results or force the trial to be terminated midway, such as alcoholism, drug abuse, substance abuse, criminal detention, etc., as well as other serious illnesses (including mental illness) requiring concomitant treatment, serious abnormal laboratory test results, or any other circumstances that may increase the risk of participation in the trial, interfere with the trial results, or make them unsuitable for participation in the trial.
研究组 & 干预措施
Treatment group B
Other
干预措施: bevacizumab (Drug)
Treatment group A
Experimental
干预措施: trastuzumab (Drug)
Treatment group A
Experimental
干预措施: bevacizumab (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: the first 108 weeks, every 12 weeks, then every 24 weeks, lasting about 3 years
Dose limited toxicity (DLT)
时间窗: up to 21 days
次要结局
- AEs+SAEs(from the first drug administration to within 40 days for the last treatment dose)
- Ctrough(from the first drug administration to within 40 days for the last treatment dose)
- ADA(from the first drug administration to within 40 days for the last treatment dose)
- Overall survival (OS)(Approximately 3 years after last subject enrolled)
- Second progression-free survival (PFS2)(the first 108 weeks, every 12 weeks, then every 24 weeks, lasting about 3 years)
- Objective Response Rate (ORR)(the first 108 weeks, every 12 weeks, then every 24 weeks, lasting about 3 years)
- Disease Control Rate (DCR)(the first 108 weeks, every 12 weeks, then every 24 weeks, lasting about 3 years)
- Duration of Response (DoR)(the first 108 weeks, every 12 weeks, then every 24 weeks, lasting about 3 years)
- Time to disease progression (TTP)(the first 108 weeks, every 12 weeks, then every 24 weeks, lasting about 3 years)
- Cancer antigen-125 response rate (CA-125 RR)(the first 108 weeks, every 12 weeks, then every 24 weeks, lasting about 3 years)
- Time to the start of subsequent treatment (TFST)(the first 108 weeks, every 12 weeks, then every 24 weeks, lasting about 3 years)
研究者
研究点 (3)
Loading locations...
相似试验
尚未招募
3 期
SYS6002 vs Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial CarcinomaUrothelial CarcinomaNCT07526792CSPC Megalith Biopharmaceutical Co.,Ltd.406
尚未招募
3 期
SYS6010 vs Investigator's Choice of Monotherapy in Patients With Recurrent or Metastatic HNSCCHead and Neck Squamous Cell CarcinomaNCT07758621CSPC Megalith Biopharmaceutical Co.,Ltd.340
尚未招募
3 期
A clinical study to assess efficacy and safety of SHR-A1811 in the treatment of patients with Relapsed Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer after undergoing platinum compound cancer therapy.Malignant neoplasm of unspecifiedovary,CTRI/2026/07/113491Glenmark Specialty SA70
招募中
1 期
A Trial of LBL-024 Monotherapy or Combination Drug in Patients With Triple Negative Breast CancerNCT07281976Nanjing Leads Biolabs Co.,Ltd220
已完成
2/3 期
A Randomized, Open label, Multicenter, Phase II / III study to assess and compare the immunogenicity and safety of NUCOVAC®-11CTRI/2025/02/081007PANACEA BIOTEC LIMITED446