The Efficacy and Safety of Iparomlimab and Tuvonralimab Injection Combined With Chemotherapy as the First-line Treatment for Esophageal Squamous Cell Carcinoma

Официальное название

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

Обзор

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.

Вмешательства

• Препарат Iparomlimab and Tuvonralimab combined with chemotherapy
  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 1. Iparomlimab and Tuvonralimab Injection: 5 mg/kg, d1, Q3W; 2. Albumin-bound paclitaxel:100-150 mg/m², d1, d8, Q3W; 3. Cisplatin: 75 mg/m², d1, Q3W;

Первичные конечные точки

• Objective response rate（ORR） [Срок оценки: 18months]

Вторичные конечные точки (5)

• Progression-free survival （PFS） [Срок оценки: 24months]
• Disease control rate (DCR) [Срок оценки: 18months]
• Duration of response (DoR) [Срок оценки: 24months]
• Overall survival（OS） [Срок оценки: 30months]
• Adverse events（AEs） [Срок оценки: 24months]

Критерии участия

Критерии включения

• 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;
• ECOG 0-1;
• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Hebei Medical University Fourth Hospital — Shijiazhuang

Идентификаторы

NCT: NCT07290010 · 2025KY012

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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