Neoadjuvant QL1706 Therapy for ESCC

Официальное название

A Single-Arm Study of Iparomlimab and Tuvonralimab (QL1706) in Combination With Chemotherapy as Neoadjuvant Therapy for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma

Обзор

This study plans to enroll 32 patients with resectable esophageal squamous cell carcinoma. The treatment regimen consists of Iparomlimab and Tuvonralimab(QL1706) combined with chemotherapy: intravenous infusion of QL1706 (5 mg/kg, q3w) in combination with albumin-bound paclitaxel (260 mg/m² on day 1, q3w) plus cisplatin (75 mg/m² on day 1, q3w) or carboplatin (AUC 5 on day 1, q3w) for 3 cycles. Surgical resection will be performed 3-6 weeks after treatment completion. Pre-treatment and surgical tissue specimens will be collected for analysis of tumor immune microenvironment changes using digital gene quantification technology. Peripheral blood samples will be obtained for dynamic ctDNA monitoring at four time points: within 7 days pre-treatment, 7 days pre-surgery, 7-30 days post-surgery, and 6 months post-surgery. The primary endpoint is the pathological complete response (pCR) rate, and secondary endpoints include major pathological response (MPR) and adverse reactions.

Вмешательства

• Препарат Iparomlimab and Tuvonralimab Injection
  QL1706 (5 mg/kg, q3w) +Paclitaxel for injection (albumin bound) (260mg/m2 D1, q3w)+cisplatin (75mg/m2 D1, q3w)/carboplatin (AUC 5 D1) ， 3 cycles

Первичные конечные точки

• pCR Rate [Срок оценки: one month after esophageal cancer surgery]

Вторичные конечные точки (4)

• MPR Rate [Срок оценки: one month after esophageal cancer surgery]
• EFS [Срок оценки: approximately 5 years]
• OS [Срок оценки: approximately 6 years]
• Safety (adverse event) [Срок оценки: From initial drug use to one month after surgery]

Критерии участия

Критерии включения

• Signed written informed consent form to voluntarily join this study;
• Age 18-75 years old, male or female;
• ECOG PS 0-1;
• Planned surgical treatment after completion of neoadjuvant therapy;
• Patients with esophageal squamous cell carcinoma diagnosed pathologically as ct1b-ct2n+or ct3-ct4a any nm0

Критерии исключения

• The subject has any active autoimmune disease or history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; the subject suffers from vitiligo; asthma has been completely relieved in childhood and does not need any intervention after adulthood can be included, but asthma that needs bronchodilators for medical intervention cannot be included);
• The subjects are using immunosuppressive agents or systemic or absorbable local hormones to achieve the purpose of immunosuppression (dose>10mg/day prednisone or other effective hormones), and continue to use them within 2 weeks before enrollment;
• Severe allergic reaction to other monoclonal antibodies;
• There are cardiac clinical symptoms or diseases that are not well controlled, such as: (1) heart failure above NYHA grade 2 (2) unstable angina pectoris (3) myocardial infarction within one year (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention (5) qtc>450ms (male); Qtc>470ms (female);
• Patients at risk of massive bleeding
• Abnormal coagulation function (inr>1.5 or pt>16s), bleeding tendency or undergoing thrombolytic or anticoagulant therapy;
• Genetic or known to exist Acquired hemorrhage and thrombotic tendency (such as hemophilia, coagulation dysfunction, thrombocytopenia, hypersplenism, etc.) or arteriovenous thrombosis events in recent 6 months (until the first use of shr-1210);
• Subjects with active infection or fever of unknown origin>38.5 degrees during screening and before the first administration;
• Patients with previous and current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, and severe impairment of lung function;
• Subjects with congenital or acquired immune deficiency (such as HIV infected), or active hepatitis (hepatitis B reference: HBV DNA detection value exceeds the upper limit of normal value; Hepatitis C reference: HCV virus titer or RNA detection value exceeds the upper limit of normal value);
• Those who have used other drugs in clinical trials within 4 weeks before the first medication;
• The subjects had previously or simultaneously suffered from other malignant tumors;
• Subjects may receive other systemic anti-tumor treatment during the study period;
• The subjects had previously received other PD-1 antibody therapy or other immunotherapy for PD-1/PD-L1;
• Live vaccines were administered less than 4 weeks before the study or during the study period;
• According to the judgment of the investigator, the subject has other factors that may lead to the forced termination of this study, such as other serious diseases (including mental diseases) requiring combined treatment, serious laboratory abnormalities, accompanied by family or social factors, which will affect the safety of the subject, or the collection of data and samples.

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

• Shandong Provincial Hospital — Цзинань

Идентификаторы

NCT: NCT06908382 · SWYX-20241055

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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