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To evaluate the efficacy of Tislelizumab combined with Nab-paclitaxel and Gemcitabine in the treatment of recurrent pancreatic cancer
There is heterogeneity in desmoplasia between different metastatic sites in pancreatic cancer. The tumor quasi-characteristics of patients with metastatic PDAC at presentation were more obvious than those of epithelial characteristics, and the quasi-and epithelial subtypes showed different responses to chemotherapy regimens, and the epithelial phenotype tumor quasi-phenotype was associated with metastasis-free survival. Therefore, different metastases of pancreatic cancer may respond differently to medical treatment. There were different metastases after postoperative recurrence of pancreatic cancer, 25.2% had only liver metastases, 14.7% had only lung metastases, 14.7% had multiple distant metastases, and about more than half of the patients had postoperative recurrence with only distant metastases and no in situ metastasis. Then whether there is a difference in the efficacy of PD1 drug therapy in patients with different metastases needs to be further verified.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tislelizumab combined with Nab-paclitaxel and Gemcitabine | Experimental |
| |
| Nab-paclitaxel and Gemcitabine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tislelizumab | Drug | Tislelizumab 200 mg every three weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 1-Year Survival Rates | The proportion of patients who survive more than 1 year after treatment. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate(ORR) | the proportion of patients who had a best overall tumor response rating of complete response (CR) or partial response (PR) | Up to 2 years |
| Progression Free Survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shiwei Guo, Doctor | Contact | +8618621500666 | gestwa@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Gang Jin, Doctor | Changhai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhai Hospital | Recruiting | Shanghai | 200433 | 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 |
|---|---|
| C000707970 | tislelizumab |
| D013660 | Taxes |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
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| Nab paclitaxel | Drug | Nab-paclitaxel 125mg/m2 on d1 and d8 every three weeks |
|
| Gemcitabine | Drug | Gemcitabine 1000mg/m2 on d1 and d8 every three weeks |
|
The time from the date of treatment to the first of either disease progression, relapse or death
| Up to 2 years |
| Overall survival (OS) | The time from the date of treatment start to the date of death or to the date of last follow-up for patients alive | Up to 2 years |
| Adverse Events (AEs) | the proportion of patients with AE, treatment-related AE (TRAE), immune-related AE (irAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0; Surgical safety including Intraoperative blood loss,PHLF assessed by ISGLS(2012),Postoperative complications evaluated by modified Clavien-Dindo system. | Up to 2 years |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D003562 |
| Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |