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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypofractionated radiotherapy+Camrelizumab+chemotherapy | Experimental | The patients with Borderline Resectable/locally advanced pancreatic cancer were treated with hypofractionated radiotherapy using the CyberKnife radiotherapy machine, which was as follows: PGTV=30Gy/5F(PTV≥25Gy/5F), 1 day, a total of 5 days; Chemotherapy combined with ICIs was started 5-7 days after the end of radiotherapy. The chemotherapy regimen was AG regimen (albumin paclitaxel 125mg/m2 d1,8 + gemcitabine 1000mg/m2 d1,8 q3w). The ICIs regimen consisted of 4 cycles of camrelizumab 200mg q21d (on the first day of each cycle). The efficacy was evaluated within 2 weeks after the end of the above-mentioned neoadjuvant therapy, and surgical treatment was performed for patients who were evaluated as operable and those who had a clear willingness to undergo surgery. After surgery, adjuvant chemotherapy and ICIs of the original scheme were determined according to the patient's tolerance and independent willingness, and then the clinical follow-up period was entered. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab+chemotherapy | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| a.R0-resection rate | The tumor was completely removed during surgery, and the cutting margins were also negative when viewed microscopically | One week after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical conversion rate | Tumors that were otherwise unresectable were transformed into surgically resectable tumors. | 2 to 4 weeks after neoadjuvant therapy |
| Tumor regression rate | Degree of tumor response to neoadjuvant therapy |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Peng | Contact | 13933868818 | pengli72@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Li Peng | Fourth Hospital of Hebei Medical | Principal Investigator |
| Fengpeng Wu | Fourth Hospital of Hebei Medical | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fourth Hospital of Hebei Medical University | Recruiting | Shijiazhuang | Hebei | 050011 | China |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D000069473 | Radiation Dose Hypofractionation |
| ID | Term |
|---|---|
| D019583 | Dose Fractionation, Radiation |
| D011879 | Radiotherapy Dosage |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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| hypofractionated radiotherapy | Radiation | Hypofractionated radiotherapy:PGTV=30Gy/5F(PTV≥25Gy/5F), |
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| One week after surgery |
| Objective response rate (ORR) | 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). | through study completion,an average of 3 year |
| Disease control rate (DCR) | 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). | through study completion,an average of 3 year |
| 3-year Overall survival (OS) | The time between the start of randomization and death from any cause | Three years from enrollment |
| 3-year Event Free Survival (EFS) | The time from randomization until disease progression, treatment discontinuation for any cause, or death. | Three years from enrollment |
| Adverse events | 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. | From enrollment to the end of treatment at 8 weeks |
| Quality of life scores | 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. | 1 years after therapy |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |