Neoadjuvant therapy for borderline resectable pancreatic cancer using radiotherapy and immunotherapy

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

This study is testing a new treatment combining radiation, chemotherapy, and immunotherapy for people with borderline resectable pancreatic cancer to see if it helps them have successful surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Hebei Medical University Fourth Hospital (Academic / other)
• Drugs / interventions: camrelizumab, immunotherapy
• Locations: 1 site (Shijiazhuang, Hebei)
• Trial ID: NCT06435260 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of a combination of hypofractionated radiotherapy, chemotherapy, and camrelizumab immunotherapy as a neoadjuvant treatment for patients with borderline resectable or locally advanced pancreatic cancer. The primary goal is to assess the surgical conversion rate and both immediate and long-term outcomes for these patients. Participants will receive the treatment regimen before any surgical intervention to potentially improve their chances of successful tumor resection.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with locally advanced pancreatic cancer that is not metastatic and meets specific diagnostic criteria.

Not a fit: Patients with distant metastasis or those whose tumors are not amenable to the defined surgical criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly increase the likelihood of surgical resection in patients with challenging pancreatic cancer cases.

How similar studies have performed: While similar approaches have been explored, this specific combination of therapies in the context of borderline resectable pancreatic cancer is relatively novel.

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. 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 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.

Where this trial is running

Shijiazhuang, Hebei

• Fourth Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (Recruiting)

Study contacts

• Principal investigator: Li Peng — Fourth Hospital of Hebei Medical
• Study coordinator: Li Peng

Conditions Pancreatic Cancer