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

Last updated: March 10, 2025
Sponsor: Hebei Medical University Fourth Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Pancreatic Cancer

Digestive System Neoplasms

Cancer

Treatment

hypofractionated radiotherapy

Camrelizumab+chemotherapy

Clinical Study ID

NCT06435260
ARK-pancreatic-001
  • Ages 18-75
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 cellcarcinoma;

  5. No distant metastasis;

  6. The pancreatic tumor is located more than 1cm away from the duodenum;

  7. 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

Exclusion Criteria:

  1. Patients who did not meet these inclusion criteria;

  2. Poor cognitive ability, inability to answer questions, inability to fill outquestionnaires, or mental disorders;

  3. The investigators think inappropriate.

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: hypofractionated radiotherapy
Phase: 2
Study Start date:
August 01, 2024
Estimated Completion Date:
June 01, 2027

Connect with a study center

  • Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei 050011
    China

    Active - Recruiting

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