Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050011, China
Location status: Recruiting
Location contact
Fengpeng Wu
PRINCIPAL_INVESTIGATOR
Li Peng
CONTACT
Li Peng
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06435260
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Phase 2
Shijiazhuang, Hebei, 050011, China
Location status: Recruiting
Fengpeng Wu
PRINCIPAL_INVESTIGATOR
Li Peng
CONTACT
Li Peng
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
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.
Hypofractionated radiotherapy:PGTV=30Gy/5F(PTV≥25Gy/5F),
Time frame: One week after surgery
The tumor was completely removed during surgery, and the cutting margins were also negative when viewed microscopically
Time frame: 2 to 4 weeks after neoadjuvant therapy
Tumors that were otherwise unresectable were transformed into surgically resectable tumors.
Time frame: One week after surgery
Degree of tumor response to neoadjuvant therapy
Time frame: through study completion,an average of 3 year
It refers to the proportion of patients who achieve a prespecified reduction in tumor volume (CR/PR) and maintain the minimum time requirements according to accepted response evaluation criteria (e.g., RECIST in solid tumors, version 1.1).
Time frame: through study completion,an average of 3 year
It refers to the proportion of patients who achieve a prespecified reduction in tumor volume (CR/PR/SD) and maintain the minimum time requirements according to accepted response evaluation criteria (e.g., RECIST in solid tumors, version 1.1).
Time frame: Three years from enrollment
The time between the start of randomization and death from any cause
Time frame: Three years from enrollment
The time from randomization until disease progression, treatment discontinuation for any cause, or death.
Time frame: From enrollment to the end of treatment at 8 weeks
Toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. The number of participants with adverse events will be recorded at each treatment visit.
Time frame: 1 years after therapy
Evaluate the quality of life according to The World Health Organization quality of life (WHOQOL) -BREF. The minimum value is 1, the maximum value is 5. And higher scores mean a better outcome. The number of participants with quality of life will be recorded at each treatment visit.
Contact information is provided by the study sponsor or research team.
Hebei Medical University Fourth Hospital
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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