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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
Tislelizumab 200 mg every three weeks
Nab-paclitaxel 125mg/m2 on d1 and d8 every three weeks
Gemcitabine 1000mg/m2 on d1 and d8 every three weeks
Changhai Hospital
Shanghai, China
RECRUITING1-Year Survival Rates
The proportion of patients who survive more than 1 year after treatment.
Time frame: Up to 2 years
Overall Response Rate(ORR)
the proportion of patients who had a best overall tumor response rating of complete response (CR) or partial response (PR)
Time frame: Up to 2 years
Progression Free Survival (PFS)
The time from the date of treatment to the first of either disease progression, relapse or death
Time frame: 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
Time frame: 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.
Time frame: Up to 2 years
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