Neoadjuvant HRS-4642 Plus Chemotherapy With or Without Immunotherapy for Pancreatic Cancer

Официальное название

An Exploratory Clinical Study of HRS-4642 in Combination With Chemotherapy With or Without Adebrelimab as Neoadjuvant Therapy for Pancreatic Cancer

Обзор

To evaluate the safety and efficacy of neoadjuvant HRS-4642 plus chemotherapy with or without adebrelimab in patients with pancreatic ductal adenocarcinoma.

Вмешательства

• Препарат HRS-4642+NALIRIFOX
  HRS-4642+NALIRIFOX
• Препарат HRS-4642+NALIRIFOX+Adebrelimab
  HRS-4642+NALIRIFOX+Adebrelimab
• Препарат HRS-4642+NALIRIFOX+Adebrelimab
  HRS-4642+NALIRIFOX+Adebrelimab

Первичные конечные точки

• Adverse events (AEs) [Срок оценки: From the first drug administration to within 30 days or within 60 days after the last dose of adebrelimab for the last dose]
• Objective Response Rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) [Срок оценки: Once every 2 cycles from enrollment through the neoadjuvant and adjuvant therapy periods or until disease progression; the evaluation period is up to 6 months]

Вторичные конечные точки (3)

• Pathologic Complete Response Rate (pCR) [Срок оценки: At the time of surgery]
• R0 (microscopically margin-negative) resection rate [Срок оценки: At the time of surgery]
• Major Pathologic Response Rate (MPR) [Срок оценки: At the time of surgery]

Критерии участия

Критерии включения

• Male and female participants aged 18-70 (including those who are 18 and 70 years old)；
• Pathologically or cytologically confirmed ductal adenocarcinoma of the pancreas; and subjects must have at least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1);
• Life expectancy ≥ 12 weeks;
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
• Adequate marrow and organ function;

Критерии исключения

• Prior receipt of any anti-tumor therapy, including but not limited to systemic chemotherapy, radiotherapy, interventional therapy, immunotherapy, targeted therapy, and anti-tumor traditional Chinese medicine therapy;
• Presence of distant metastatic lesions confirmed by imaging;
• Known hypersensitivity to the investigational drug or any of its excipients;
• Presence of any serious or uncontrolled systemic disease;
• History of allogeneic hematopoietic stem cell transplantation or solid organ transplantation;
• Clinically significant acute or chronic pancreatitis;
• Participation in any interventional clinical trial involving drugs or medical devices within 4 weeks prior to the first administration of study treatment;
• Vaccination with live or live-attenuated vaccines within 4 weeks prior to the first dose of the investigational drug;
• Any other condition that, in the judgment of the investigator, makes the subject unsuitable for enrollment.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07691593 · PANC-HRS4642-SHR1316-NALIRIFOX

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗