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The objective of this study is to evaluate the efficacy and safety of concurrent chemoradiotherapy combined with immunotherapy in patients with potentially resectable pancreatic cancer.
Due to the hidden onset and rapid progression of pancreatic cancer, most patients are already locally advanced or have distant metastasis at the time of diagnosis and lose the opportunity for surgery. Even among operable patients, about 50% will have recurrence and metastasis one year after surgery. Therefore, more and more evidence supports neoadjuvant therapy for patients with high risk factors for resectable pancreatic cancer, and conversion therapy followed by surgery for patients with borderline resectable and locally advanced pancreatic cancer. Therefore, the objective of this study is to evaluate the efficacy and safety of concurrent chemoradiotherapy combined with immunotherapy in patients with potentially resectable pancreatic cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Concurrent radiochemotherapy combined with immunotherapy | Experimental | Participants will receive tislelizumab plus gemcitabine and nab-paclitaxel in cycles of 21 days. Non-progressors will plus concurrent radiotherapy during the 3rd cycle of chemotherapy. After 4-6 cycles treatment, Multiple disciplinary team (MDT) will evaluate whether to undergo radical surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tislelizumab | Drug | Tislelizumab 200mg administered intravenously on Days 1 of every 3 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | RECIST Version 1.1 | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| R0 resection rate | R0 resection rate | Up to 1 years |
| Median Progression Free Survival (mPFS) | RECIST Version 1.1 | Up to 2 years |
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Inclusion Criteria:
1. Age >= 18 years; 2. Eastern Cooperative Oncology Group (ECOG) score of 0-1; 2. Pancreatic cancer confirmed by histology or cytology; 3. Potentially resectable pancreatic cancer documented by contrast enhanced CT (or MRI) scan; 4. Hematological indexes: Neutrophil count >= 1.5 x 10^9/L Hemoglobin >= 10g / dl Platelet count >= 100 x 10^9 / L 5. Biochemical indicators: Total bilirubin <= 1.5 x upper limit of normal value (ULN); Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) < 1.5 x ULN; Creatinine clearance rate >= 60ml / min.
6. Participants of childbearing age need to take appropriate protective measures (contraceptive measures or other methods of birth control) before entering the group and during the test: 7. Signed informed consent; 8. Follow the protocol and follow-up procedures.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juan Du, MD | Contact | 86-25-83106666 | dujuanglyy@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Recruiting | Nanjing | Jiangsu | 210008 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41324566 | Derived | Ni J, Sun Y, Cheng H, Bai X, Tong F, Zhang X, Wang X, Mao L, Li G, Shen S, Kong W, He J, Li A, Chen J, Tang M, Chen B, Li Q, Gu Q, Lu Z, Chen D, Sha H, Liu B, Qiu Y, Du J. Tislelizumab and Hypofractionated Radiotherapy plus Nab-Paclitaxel/Gemcitabine as Conversion Therapy for BRPC/LAPC: A Phase II Trial with Dynamic Biomarker Monitoring. Clin Cancer Res. 2026 Feb 4;32(3):516-527. doi: 10.1158/1078-0432.CCR-25-2461. |
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| Gemcitabine | Drug | Gemcitabine 1000 mg/m^2 administered intravenously on Days 1 & 8 of every 3 weeks. |
|
| Nab paclitaxel | Drug | Gemcitabine 125 mg/m^2 administered intravenously on Days 1 & 8 of every 3 weeks. |
|
| Hypofractionated radiotherapy with simultaneous integrated boost | Radiation | Radiotherapy plan: Planning gross tumor volume (PGTV) 5Gy*10 fractions, Planning target volume (PTV) 3Gy*10 fractions. |
|
| Median Overall survival (mOS) | RECIST Version 1.1 | Up to 2 years |
| Disease control rate (DCR) | RECIST Version 1.1 | Up to 2 years |
| Pathological grade of tumor tissue after neoadjuvant therapy | Pathological grade of tumor tissue after neoadjuvant therapy | Up to 1 years |
| Adverse Events | Adverse event (AE)、Serious adverse event (SAE) | Up to 2 years |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000707970 | tislelizumab |
| D000093542 | Gemcitabine |
| D013660 | Taxes |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
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