FOLFIRINOX + NIS793 in Pancreatic Cancer (NCT05417386) | Clinical Trial Compass
TerminatedPhase 1
FOLFIRINOX + NIS793 in Pancreatic Cancer
Stopped: NIS793 is no longer being developed
United States4 participantsStarted 2022-08-09
Plain-language summary
This research is being done to evaluate the safety and effectiveness of the drug NIS793 in combination with the standard of care treatment FOLFIRINOX (consists of the drugs 5-Fluorouracil (5-FU), Oxaliplatin, Irinotecan, and Leucovorin), chemoradiation and surgery for people with metastatic pancreas adenocarcinoma.
The drugs involved in this study are:
* NIS793
* FOLFIRINOX (consists of the drugs 5-Fluorouracil (5-FU), Oxaliplatin, Irinotecan, and Leucovorin)
Other interventions include
* chemoradiation
* surgery.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Safety Run-in Cohort: Histologically confirmed metastatic pancreatic adenocarcinoma without prior therapy for pancreatic adenocarcinoma.
* Phase 1B Cohort: Histologically confirmed locally advanced disease (borderline resectable or locally advanced pancreatic adenocarcinoma) or poorly differentiated adenosquamous carcinoma includes both borderline resectable or locally advanced disease. Patients with localized pancreas adenocarcinoma cannot have received any prior therapy for borderline resectable or locally advanced pancreas adenocarcinoma
* Borderline Resectable Disease: Defined by the NCCN as tumors with venous involvement of the SMV/portal vein demonstrated tumor abutment with or without impingement and narrowing of the lumen, either tumor thrombus or encasement but with suitable vessel proximal and distal to the area of vessel involvement, allowing for safe resection or reconstruction; gastroduodenal artery encasement up to the hepatic artery with either short segment encasement or direct abutment of the hepatic artery, without extension to the celiac axis; or tumor abutment of the SMA not to exceed greater than 180 degrees of the circumference of the vessel wall.Tumors involving retroperitoneal structures that can be surgically removed (i.e.kidney), will also be included.
* Locally Advanced Pancreas Adenocarcinoma: Defined by the NCCN as: Tumors of the head that have greater than 180 degrees of SMA encasement or any celiac abutment, unreconstructa…