A Study of KC1036 Versus Investigator's Choice of Chemotherapy in Patients With Advanced Esophageal Cancer

Официальное название

A Randomized, Controlled, Open-label, Multicenter Phase III Study to Evaluate the Efficacy and Safety of KC1036 Versus Investigator's Choice of Chemotherapy as Third-line Therapy in Patients With Advanced Esophageal Squamous Cell Carcinoma

Обзор

The purpose of this study is to evaluate the efficacy and safety of KC1036 versus investigator's choice of chemotherapy in patients with advanced recurrent or metastatic esophageal squamous cell carcinoma

Подробное описание

This is a randomized, controlled, open-label, multicenter phase III trial. Patients with advanced recurrent or metastatic esophageal squamous cell carcinoma that has received PD-1 or PD-L1 inhibitors and at least second-line systemic therapy will be randomized at a 1: 1 ratio to receive KC1036 or the investigator's choice of chemotherapy (Irinotecan/Docetaxel/S-1) until confirmed disease progression assessed by the RECIST V1.1 standard, death, intolerable toxicity, initiation of a new anti-tumor therapy, other reasons leading to treatment discontinuation as specified by protocol.

Вмешательства

• Препарат KC1036
  KC1036 60mg QD orally, before a meal, continuous administration, 21 days as a cycle
• Препарат Irinotecan
  Irinotecan intravenously administered at 130-150 mg/m2 once every 2 weeks
• Препарат Docetaxel
  Docetaxel intravenously administered at 60-75 mg/m2 once every 3 weeks；
• Препарат S-1
  S-1 orally administered 40-60mg Bid on Day 1 to Day 14 of every 3 weeks, 21 days as a cycle

Первичные конечные точки

• Overall survival (OS) [Срок оценки: Baseline to study completion (approximately 24 months)]

Вторичные конечные точки (6)

• Objective Response Rate (ORR) [Срок оценки: Baseline to study completion (approximately 24 months)]
• Disease Control Rate (DCR) [Срок оценки: Baseline to study completion (approximately 24 months)]
• Duration of Response (DOR) [Срок оценки: Baseline to study completion (approximately 24 months)]
• Progression-free survival (PFS) [Срок оценки: Baseline to study completion (approximately 24 months)]
• Incidence of Adverse events (AEs) [Срок оценки: Baseline to 30 days after the last dose of study treatment]
• Quality of Life (QOL) scores [Срок оценки: Baseline to study completion (approximately 24 months)]

Критерии участия

Критерии включения

• Males or females aged 18 to 75 years;
• Histologically or cytologically confirmed esophageal or esophageal-gastric junction squamous cell carcinoma;
• Patient with advanced recurrent or metastatic esophageal squamous cell carcinoma previously treated with a PD-1 or PD-L1 inhibitor and at least second-line systemic therapy;
• At least one measurable tumor lesion according to RECIST 1.1;
• Eastern Cooperative Oncology Group performance status score of 0 or 1;
• Life expectancy > 12 weeks;
• BMI≥16.0 and weight≥40 kg ;
• Adequate bone marrow, renal, and hepatic function;
• Female patients of childbearing potential with a negative blood pregnancy test completed within 7 days before randomization；
• Patients should participate in the study voluntarily and sign informed consent.

Критерии исключения

• Any patient who is known to have untreated central nervous system (CNS) metastasis;
• Other kinds of malignancies within 5 years;
• Gastrointestinal abnormalities;
• Cardiovascular and cerebrovascular diseases;
• Prior therapies with vascular targeting inhibitor；
• Previously treated with Irinotecan, Docetaxel and Tegafur Gimeracil Oteracil Potassium；
• Involved in other clinical trials within 4 weeks before enrollment；Prior anti-tumor therapies with radiotherapy, immunotherapy, operation within 4 weeks before enrollment;Prior anti-tumor therapies with small molecule targeting drugs within 2weeks or 5 half-lives (whichever is longer) before enrollment; Prior anti-tumor therapies with chemotherapy within 3 weeks or 5 half-lives (whichever is longer) before enrollment;
• Presence of unresolved toxicities from prior anti-tumor therapy, defined as having not resolved to NCI CTCAE 5.0 Grade 0 or 1;
• Uncontrolled massive ascites, pleural or pericardial effusion;
• Severe infection within 4 weeks prior to randomization (CTCAE > Grade 2);
• Known history of human immunodeficiency virus (HIV) infection or current active hepatitis B or C infection;
• Pregnant or lactating women;
• Female subjects of child-bearing potential and male subjects of reproductive capacity who do not agree to use contraceptive measures during the study and for 6 months after the end of the study.
• Other patients are not eligible for enrollment assessed by investigators.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Cancer Hospital, Chinese Academy of Medical Sciences — Пекин

Идентификаторы

NCT: NCT06194734 · KC1036-III-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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