NCT06435260 Hypofractionated Radiotherapy +Chemotherapy+ Camrelizumab as Neoadjuvant Therapy for Pancreatic Cancer
| NCT ID | NCT06435260 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Hebei Medical University Fourth Hospital |
| Condition | Pancreatic Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2025-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2024-08-01 with a primary completion date of 2025-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Li Peng
PRINCIPAL INVESTIGATOR
Fourth Hospital of Hebei Medical
Frequently Asked Questions
Who can join the NCT06435260 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Pancreatic Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06435260 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06435260 currently recruiting?
Yes, NCT06435260 is actively recruiting participants. Contact the research team at pengli72@sina.com for enrollment information.
Where is the NCT06435260 trial being conducted?
This trial is being conducted at Shijiazhuang, China.
Who is sponsoring the NCT06435260 clinical trial?
NCT06435260 is sponsored by Hebei Medical University Fourth Hospital. The principal investigator is Li Peng at Fourth Hospital of Hebei Medical. The trial plans to enroll 30 participants.
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