A Phase 2 interventional study of Tislelizumab and Nab paclitaxel in Recurrent Pancreatic Cancer, sponsored by Changhai Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-01.
Sponsored by Changhai Hospital · Phase 2, Interventional, and Treatment
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.
3,310 studies on the registry are indexed under Pancreatic Neoplasms; 910 are open to participants now.
This study's planned enrollment of 140 is above the median of 46 across 2,480 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Changhai Hospital is the lead sponsor of 354 studies on the registry; 136 are open to participants now.
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Drug: Tislelizumab · Drug: Nab paclitaxel · Drug: Gemcitabine
Drug: Nab paclitaxel · Drug: Gemcitabine
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
1-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
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2020 (actual). Primary completion is estimated for Nov 2023, 36 months after the start.
Of 297 non-industry phase 2 interventional studies under Pancreatic Neoplasms, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 80. This study's planned 36 months is below that.
Counting every sponsor, half of 364 studies reached it within 57 months; a quarter within 34 and three quarters within 80.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tislelizumab