NCT07263919招募中2 期
A Randomized, Controlled, Multi-center Phase II/III Clinical Trial of Perioperative Cadonilimab Combined With Neoadjuvant Chemotherapy in Patients With Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma (ESCC)
Akeso1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年12月19日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Pathologic Complete Response (pCR) rate as assessed by the investigator
研究概览
简要总结
This is a randomized, controlled, multi-center phase II/III study. All patients are resectable locally advanced thoracic esophageal squamous cell carcinoma (ESCC), Eastern Cooperative Oncology Group (ECOG) performance status 0-1. The purpose of this study is to evaluate the efficacy and safety of perioperative Cadonilimab combined with neoadjuvant chemotherapy versus neoadjuvant chemotherapy in patients with resectable 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
- •Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures).
- •≥18 years old and ≤ 75 years (regardless of sex).
- •Pathologically confirmed esophageal squamous cell carcinoma, assessed as resectable.
- •Adequate pulmonary function.
- •Adequate tumor tissue samples.
- •ECOG performance status of 0-
- •Adequate organ function.
- •Within 7 days prior to the first dose, women of childbearing potential must have a negative urine or serum pregnancy test and agree to use effective contraception during the study treatment period and for 120 days after the last dose.
排除标准
- •Presence of suspected distant metastatic lesions, or locally advanced unresectable disease.
- •Histologically confirmed as other pathological types.
- •Previous surgery precludes the use of gastric substitution for esophageal reconstruction in the current procedure.
- •History of other malignant tumors within the past 5 years.
- •Within 4 weeks prior to randomization, presence of conditions such as severe esophagogastric varices, active ulcers, unhealed wounds, gastrointestinal perforation, or intestinal obstruction.
- •Active or documented history of inflammatory bowel disease.
- •Clinically symptomatic or recurrent pleural, pericardial, or ascitic fluid requiring drainage.
- •Uncontrolled concurrent illnesses.
- •Acute exacerbation of chronic obstructive pulmonary disease within 4 weeks prior to randomization.
- •History of myocardial infarction, unstable angina, congestive heart failure within 12 months prior to day 1 of study treatment.
- •History of severe bleeding tendency or coagulation dysfunction.
- •Arterial thromboembolic events within 6 months prior to randomization.
- •History or current presence of non-infectious pneumonitis/interstitial lung disease requiring systemic glucocorticoids.
- •Known psychiatric disorders, drug abuse, or substance addiction.
- •Pregnant or lactating women.
- •Prior systemic or local antitumor therapy for locally advanced esophageal squamous cell carcinoma.
- •Systemic non-specific immunomodulatory therapy within 2 weeks prior to randomization.
- •Major surgery or severe trauma within 4 weeks prior to randomization.
- •Known allergy to any component of the investigational drug(s).
- •Active autoimmune disease requiring systemic treatment within 2 years prior to randomization.
- •Active hepatitis B infection.
- •Known active tuberculosis.
- •Severe infections within 4 weeks prior to randomization.
- •History of immunodeficiency or positive HIV test.
- •Known active syphilis infection.
- •Live vaccination within 4 weeks prior to randomization or planned during the study.
- •History of allogeneic organ transplantation or hematopoietic stem cell transplantation.
- •Is currently participating in a study of an investigational agent or using an investigational device.
研究组 & 干预措施
Cadonilimab (dose 1) combined with Cisplatin and Paclitaxel
Experimental
干预措施: Cadonilimab (AK104) (Drug)
Cadonilimab (dose 1) combined with Cisplatin and Paclitaxel
Experimental
干预措施: Cisplatin (Drug)
Cadonilimab (dose 1) combined with Cisplatin and Paclitaxel
Experimental
干预措施: Paclitaxel (Drug)
Cadonilimab (dose 2) combined with Cisplatin and Paclitaxel
Experimental
干预措施: Cadonilimab (AK104) (Drug)
Cadonilimab (dose 2) combined with Cisplatin and Paclitaxel
Experimental
干预措施: Cisplatin (Drug)
Cadonilimab (dose 2) combined with Cisplatin and Paclitaxel
Experimental
干预措施: Paclitaxel (Drug)
Cisplatin and Paclitaxel
Active Comparator
干预措施: Cisplatin (Drug)
Cisplatin and Paclitaxel
Active Comparator
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Pathologic Complete Response (pCR) rate as assessed by the investigator
时间窗: Up to approximately 2 years
Proportion of subjects with no tumor residue in the primary tumor and regional lymph nodes.
Adverse Event (Phase II stage)
时间窗: Up to approximately 5 years
Incidence and severity of adverse events (AEs), rate of delayed surgery, and clinically significant abnormal laboratory findings.
次要结局
- Major Pathological Response (MPR) rate as assessed by the investigator(Up to approximately 2 years)
- R0 resection rate(Up to approximately 2 years)
- Event Free Survival (EFS)(Up to approximately 5 years)
- Disease Free Survival (DFS)(Up to approximately 5 years)
- Overall Survival (OS)(Up to approximately 5 years)
- Overall Response Rate (ORR)(Up to approximately 2 years)
- Disease Control Rate (DCR)(Up to approximately 2 years)
- Pharmacokinetics (PK)(Up to approximately 2 years)
- Anti-Drug Antibodies(ADAs)(Up to approximately 2 years)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
2 期
A Phase II Study of PEG-rhGH Injection for Short Children Born Small for Gestational Age: Efficacy, Safety, and PharmacokineticsNCT07260500Changchun GeneScience Pharmaceutical Co., Ltd.72
招募中
2 期
A Study of BL-M07D1 in Combination With Pembrolizumab in Patients With Unresectable Locally Advanced or Metastatic HER2-Overexpressing Non-Squamous NSCLCNCT07264816Sichuan Baili Pharmaceutical Co., Ltd.80
招募中
3 期
A study to evaluate the efficacy and safety of Clascoterone solution in treatment of male pattern hair loss.Androgenetic Alopecia2023-504421-39-00Cassiopea S.p.A.629
招募中
4 期
A Study of Teprotumumab N01 in Subjects With Active Thyroid Eye DiseaseThyroid Eye DiseaseNCT07265258Innovent Biologics (Suzhou) Co. Ltd.92
招募中
1 期
A PHASE 1B, MULTICENTER, RANDOMIZED, PLACEBO- CONTROLLED, DOUBLE-BLIND STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND BIOLOGICAL ACTIVITY OF TQS-168 IN SUBJECTS WITH AMYOTROPHIC LATERAL SCLEROSIS2023-504746-54-00Tranquis Therapeutics Inc.16