Hypofractionated Radiotherapy +Chemotherapy+ Camrelizumab as Neoadjuvant Therapy for Pancreatic Cancer

Официальное название

To Explore the Efficacy of Hypofractionated Radiotherapy Followed by AG Regimen Chemotherapy Plus Camrelizumab Immunotherapy as Neoadjuvant Therapy for Borderline Resectable/Locally Advanced Pancreatic Cancer

Обзор

The purpose of this study is to assess surgical conversion rate and the immediate and long-term outcomes to patients who receive hypofractionated radiotherapy and AG combined with camrelizumab immunotherapy of Borderline Resectable/locally advanced pancreatic cancer.

Вмешательства

• Препарат Camrelizumab+chemotherapy
  Chemotherapy combined with ICIs was started 5-7 days after the completion of radiotherapy: AG: intravenous nab-paclitaxel 125 mg/m2 and gemcitabine 1000mg/m2 d1,8, q3w, 4 cycles. Camrelizumab: 200mg, iv, 30min, q3w, 4 cycles.
• Лучевая терапия hypofractionated radiotherapy
  Hypofractionated radiotherapy:PGTV=30Gy/5F(PTV≥25Gy/5F),

Первичные конечные точки

• a.R0-resection rate [Срок оценки: One week after surgery]

Вторичные конечные точки (8)

• Surgical conversion rate [Срок оценки: 2 to 4 weeks after neoadjuvant therapy]
• Tumor regression rate [Срок оценки: One week after surgery]
• Objective response rate (ORR) [Срок оценки: through study completion，an average of 3 year]
• Disease control rate (DCR) [Срок оценки: through study completion，an average of 3 year]
• 3-year Overall survival (OS) [Срок оценки: Three years from enrollment]
• 3-year Event Free Survival (EFS) [Срок оценки: Three years from enrollment]
• Adverse events [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Quality of life scores [Срок оценки: 1 years after therapy]

Критерии участия

Критерии включения

• Age:18 to 75 years old, male or female;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
• Tumor was located in the pancreas;
• Pathological diagnosis was pancreatic ductal adenocarcinoma or acinar cell carcinoma;
• No distant metastasis;
• The pancreatic tumor is located more than 1cm away from the duodenum；
• Clinical assessment was locally advanced or critical for resectable.

Locally advanced pancreatic cancer diagnostic criteria: (1) due to tumor invasion, venous occlusion or involving a wide range of superior mesenteric vein branch of jejunum, cannot safely - superior mesenteric vein reconstruction. ② (pancreatic head/uncinate process tumors) tumor contact with superior mesenteric artery or celiac artery > 180°. Tumor contact with superior mesenteric artery or coeliac trunk artery > 180°, tumor contact with coeliac trunk artery and invasion of abdominal aorta.

Critical for resectable pancreatic cancer diagnostic criteria: (1) contact with portal vein tumor - superior mesenteric vein > 180 °, 180 ° or less or contact combined intravenous contour irregular or venous thrombosis, but safety is complete resection and reconstruction; The tumor contacted the inferior vena cava. ② (pancreatic head/uncinate process tumors) the tumors contacting the common hepatic artery, but not involving the celiac artery or the origin of the left and right hepatic arteries, can be completely resected and safely reconstructed; Superior mesenteric artery tumor contact 180 ° or less; The tumor contacts the aberrant arteries (such as accessory right hepatic artery, alternative right hepatic artery, alternative common hepatic artery, etc.). (pancreatic body and tail tumors) tumor contact with superior mesenteric artery ≤180°; Tumor contact with celiac artery ≤180°; 7.There was no history of immune system diseases, other malignant tumors, myocarditis, coronary heart disease, other cardiovascular and cerebrovascular diseases, thyroid dysfunction, liver and kidney diseases, psychiatric diseases, infectious diseases, or systemic diseases other than those mentioned above.

Participants were willing to join in this study, good adherence and written informed consent.

Критерии исключения

• Patients who did not meet these inclusion criteria;
• Poor cognitive ability, inability to answer questions, inability to fill out questionnaires, or mental disorders;
• The investigators think inappropriate.

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

• Fourth Hospital of Hebei Medical University — Shijiazhuang

Идентификаторы

NCT: NCT06435260 · ARK-pancreatic-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗