Trials
Search / Trial NCT06435260

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

Launched by HEBEI MEDICAL UNIVERSITY FOURTH HOSPITAL · May 29, 2024

Trial Information

Current as of February 12, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach for locally advanced pancreatic cancer. The researchers want to see if a combination of focused radiation therapy, chemotherapy (the AG regimen), and immunotherapy (called camrelizumab) can help patients become eligible for surgery. Essentially, they are looking to understand how effective this treatment is in making the tumors smaller or easier to remove, and what the overall outcomes are for patients who receive it.

To be eligible for this study, participants need to be between 18 and 75 years old, have a specific type of pancreatic cancer, and their tumors must meet certain criteria that make them locally advanced but potentially resectable (able to be surgically removed). This trial is currently open for recruitment, and all genders can participate. If someone joins this study, they can expect to receive the treatment and be monitored closely for their response and any side effects, helping researchers gather important information about this approach for future patients.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Age:18 to 75 years old, male or female;
  • 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
  • 3. Tumor was located in the pancreas;
  • 4. Pathological diagnosis was pancreatic ductal adenocarcinoma or acinar cell carcinoma;
  • 5. No distant metastasis;
  • 6. 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.
  • Exclusion Criteria:
  • 1. Patients who did not meet these inclusion criteria;
  • 2. Poor cognitive ability, inability to answer questions, inability to fill out questionnaires, or mental disorders;
  • 3. The investigators think inappropriate.

Trial Officials

Li Peng

Principal Investigator

Fourth Hospital of Hebei Medical

Fengpeng Wu

Principal Investigator

Fourth Hospital of Hebei Medical

About Hebei Medical University Fourth Hospital

Hebei Medical University Fourth Hospital is a leading healthcare institution dedicated to advancing medical research and patient care. As a clinical trial sponsor, the hospital is committed to conducting high-quality, ethical research that contributes to the development of innovative therapies and medical solutions. With a multidisciplinary team of experienced professionals, state-of-the-art facilities, and a focus on patient safety and scientific integrity, Hebei Medical University Fourth Hospital plays a vital role in enhancing clinical knowledge and improving health outcomes within the community and beyond.

Locations

Shijiazhuang, Hebei, China

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0