NCT07751341招募中2 期
A Randomized, Controlled, Open-label, Multicenter Phase II Clinical Study of SHR-9839 as Monotherapy or in Combination With Chemotherapy Plus Adebrelimab Versus Chemotherapy Plus Adebrelimab in Patients With Advanced Esophageal Squamous Cell Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 4
- 主要终点
- ORR：Objective Response Rate
研究概览
简要总结
An open-label, multicenter, randomized, phase II clinical trial to evaluate the safety, tolerability and efficacy of SHR-9839(sc) as monotherapy or in combination with chemotherapy plus adebelimab in patients with advanced esophageal squamous cell carcinoma (ESCC).
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
- •Capable of providing informed consent; has signed and dated the IRB/EC-approved informed consent form, and is willing and able to comply with scheduled study visits, examinations and all other protocol-specified procedures.
- •Aged between 18 and 75 years inclusive at the time of informed consent signature, irrespective of gender.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Histopathologically confirmed locally advanced unresectable or metastatic esophageal squamous cell carcinoma (ESCC).
- •Expected survival ≥12 weeks.
- •Must provide a minimum of 11 formalin-fixed paraffin-embedded (FFPE) tumor tissue blocks or unstained tumor slides.
- •Females of childbearing potential must agree to use adequate effective contraception from the date of informed consent, throughout study treatment, and for 9 months after the last dose of investigational product, and refrain from oocyte donation during this period (refer to subsequent section for detailed contraceptive requirements).
排除标准
- •Uncontrolled or symptomatic active central nervous system (CNS) metastases without adequate prior treatment.
- •History of another concurrent malignant tumor diagnosed within 3 years prior to the first study drug administration.
- •Presence of uncontrolled tumor-related pain as assessed by the Investigator.
- •Severe cardiovascular or cerebrovascular diseases.
- •History of interstitial lung disease (ILD) including idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans organizing pneumonia), drug-induced pneumonitis, radiation pneumonitis requiring steroid therapy; or suspected/unruled-out ILD on screening imaging; or moderate-to-severe pulmonary disease severely impairing respiratory function.
- •Severe infection within 4 weeks before study treatment initiation, including but not limited to bacteremia, severe pneumonia or other infectious complications requiring hospitalization; active CTCAE Grade ≥2 infection requiring systemic antibiotics within 2 weeks prior to first dose (subjects on prophylactic antibiotics e.g., for urinary tract infection prophylaxis are eligible).
- •History of immunodeficiency including positive HIV serology; active hepatitis B (positive HBsAg at screening plus HBV-DNA ≥2500 copies/mL /500 IU/mL or above local laboratory cutoff); or active hepatitis C (positive anti-HCV plus detectable HCV RNA).
- •Active pulmonary tuberculosis within 1 year before enrollment by medical history or imaging; or prior active pulmonary tuberculosis >1 year ago without standardized anti-tuberculosis treatment.
- •Toxicities/complications from prior anti-tumor therapies not recovered to NCI-CTCAE Grade ≤1 or levels specified by eligibility criteria; subjects with Grade ≤2 toxicities may enroll if deemed without safety risk by the Investigator.
- •Receipt of any systemic anti-cancer therapy within 4 weeks prior to study treatment start.
- •Thoracic radiotherapy >30 Gy within 24 weeks, non-thoracic radiotherapy >30 Gy within 4 weeks before first dose; palliative radiotherapy ≤30 Gy within 14 days before first dose (exception: subjects completing brain metastasis radiotherapy ≥14 days prior to first dose are permitted). For prior radioisotope therapy, a washout of at least five half-lives of the radioisotope is required before study enrollment.
- •Major organ surgery (excluding core needle biopsy) or significant trauma within 4 weeks before first study drug, or planned elective surgery during trial participation; invasive minor surgery (biopsy, endoscopy, drainage procedure) within 7 days prior to first dose.
- •Any other condition judged by the Investigator likely to interfere with trial conduct or subject safety, such as alcohol/drug abuse, uncontrolled severe illness (including psychiatric disorders) requiring concomitant medication, clinically significant abnormal laboratory findings, familial/social issues or other factors compromising subject safety or data integrity.
研究组 & 干预措施
Treatment group A
Experimental
干预措施: SHR-9839(sc) for Injection (Drug)
Treatment group B : Safety run-in Stage/Dose extension Stage
Experimental
干预措施: SHR-9839(sc) for Injection、Adebrelimab Injection、Paclitaxel for Injection、Cisplatin Injecion (Drug)
结局指标
主要结局
ORR：Objective Response Rate
时间窗: First administration to end of treatment visit about 1year
次要结局
- DCR：Disease Control Rate(First administration to disease progression about 1 year)
- DOR：Duration of relief(First administration to disease progression about 1 year)
- MTD： The Maximum Tolerated Dose(Post-dose at day 1 to Day21)
- PFS：progression-free survival(First administration to disease progression about 1 year)
- OS：Overall Survival(First administration until participant's death about 2 years)
- DLT：The Dose-Limiting Toxicity(Post-dose at day 1 to Day21)
- AE：Incidence and severity of adverse events(Sign the informed consent form until Safety follow-up completed about 1 year)
- ADA ：Anti-Drug Antibody(Day1 pre-dose to 30 days after the last dose about 1 year)
研究者
研究点 (4)
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