NCT07290010招募中2 期
A Clinical Trial to Explore the Efficacy and Safety of Iparomlimab and Tuvonralimab Injection Combined With Chemotherapy as the First-line Treatment for Recurrent or Metastatic Esophageal Squamous Cell Carcinoma
Hebei Medical University Fourth Hospital1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2025年9月26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
- 25
- 试验地点
- 1
- 主要终点
- Objective response rate（ORR）
研究概览
简要总结
This study is a single-arm clinical trial to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab combined with chemotherapy in the first-line treatment of patients with recurrent or metastatic esophageal squamous cell carcinoma (ESCC). After screening and meeting the inclusion criteria, the patients were enrolled and received 6 cycles of Iparomlimab and Tuvonralimab combined with albumin-bound paclitaxel and cisplatin. Subsequently, maintenance treatment was carried out using Iparomlimab and Tuvonralimab ± albumin-bound paclitaxel until disease progression or the occurrence of unacceptable adverse events, with a total maximum treatment duration of 24 months.
The main objective of this study is to: 1. evaluate the ORR of Iparomlimab and Tuvonralimab combined with albumin-bound paclitaxel and cisplatin. 2. The secondary endpoints include PFS, DCR, DoR, OS and safety, etc.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years old, gender not limited;
- •Unresectable, recurrent or advanced metastatic esophageal squamous cell carcinoma confirmed by histopathological examination (excluding adenosquamous carcinoma mixed type and other pathological types);
- •For patients who have previously received adjuvant/neoadjuvant chemotherapy/chemoradiotherapy, or radical concurrent chemoradiotherapy , the time from the last treatment to disease recurrence is more than 6 months;
- •According to RECIST v1.1, there is at least one measurable lesion;
- •Be capable of providing newly obtained or archived tissue samples for immunohistochemical analysis of PD-L1 expression;
- •The patient's organ functions are normal, with no serious abnormalities in blood, heart, lung, liver or kidney functions, and no immune deficiency diseases.
- •The patient has normal coagulation function and no active bleeding or thrombotic diseases.
- •Expected survival time ≥12 weeks;
- •Male subjects who are female of childbearing age or whose sexual partners are female of childbearing age must take effective contraceptive measures throughout the treatment period and for 6 months after the treatment period.
- •Voluntarily sign a written informed consent form and be able to comply with the visitation and related procedures stipulated in the plan
排除标准
- •Locally advanced esophageal cancer that can be potentially cured through radical surgical resection or radiotherapy;
- •Esophageal squamous cell carcinoma that is known to have complete obstruction under endoscopy and requires interventional treatment to relieve the obstruction;
- •There is a risk of perforation after stent implantation in the esophageal or tracheal cavity;
- •Has received systemic treatment for advanced or metastatic esophageal squamous cell carcinoma in the past;
- •Other malignant tumors diagnosed within 5 years prior to the first administration, except for effectively treated cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma and/or effectively resected cervical cancer and/or breast cancer in situ;
- •Severe infection occurs (CTCAE>grade 2), or active pulmonary inflammation;
- •Previous or current interstitial pneumonia, pneumoconiosis, drug-related pneumonia, or severe lung function impairment;
- •Patients with active tuberculosis infection;
- •Participate in another interventional clinical study simultaneously, unless participating in an observational (non-interventional) clinical study or being in the follow-up stage of an interventional study;
- •Patients with congenital or acquired immune deficiencies, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA ≥ 500 IU/ml), hepatitis C (positive hepatitis C antibody and HCV-RNA above the detection limit), or patients with co-infection of hepatitis B and hepatitis C;
- •There is a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- •Having undergone major surgical operations (craniotomy, thoracotomy or laparotomy) within 4 weeks prior to the first dose of the study treatment or expecting to undergo major surgeries during the study treatment period;
- •It is known that there are symptomatic central nervous system metastases and/or cancerous meningitis (except for stable brain metastases that do not require steroid treatment);
- •It is known that there is an active autoimmune disease requiring symptomatic treatment or a history of the disease within the past 2 years (patients with vitiligo, psoriasis, alopecia or Graves' disease that do not require systemic treatment in the past 2 years, hypothyroidism who only need thyroid hormone replacement therapy, and type 1 diabetes who only need insulin replacement therapy can be enrolled).
- •Female patients who are pregnant or breastfeeding;
- •Any serious or uncontrolled systemic disease that researchers believe may increase the risk of participation in patients
研究组 & 干预措施
Iparomlimab and Tuvonralimab combined with chemotherapy
Experimental
Patients were enrolled and received 6 cycles of Iparomlimab and Tuvonralimab combined with albumin-bound paclitaxel and cisplatin. Subsequently, maintenance treatment was carried out using Iparomlimab and Tuvonralimab ± albumin-bound paclitaxel until disease progression or the occurrence of unacceptable adverse events
- Iparomlimab and Tuvonralimab Injection: 5 mg/kg, d1, Q3W;
- Albumin-bound paclitaxel:100-150 mg/m², d1, d8, Q3W;
- Cisplatin: 75 mg/m², d1, Q3W;
干预措施: Iparomlimab and Tuvonralimab combined with chemotherapy (Drug)
结局指标
主要结局
Objective response rate（ORR）
时间窗: 18months
The objective response rate (ORR) evaluated by investigator based on RECIST 1.1
次要结局
- Progression-free survival （PFS）(24months)
- Disease control rate (DCR)(18months)
- Duration of response (DoR)(24months)
- Overall survival（OS）(30months)
- Adverse events（AEs）(24months)
研究者
研究点 (1)
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