Study protocol for an open-label, single-arm, phase Ib/II study of combination of toripalimab, nab-paclitaxel, and gemcitabine as the first-line treatment for patients with unresectable pancreatic ductal adenocarcinoma.
Adolescent
Adult
Aged
Aged, 80 and over
Albumins
/ administration & dosage
Antibodies, Monoclonal, Humanized
/ administration & dosage
Antineoplastic Combined Chemotherapy Protocols
/ therapeutic use
Carcinoma, Pancreatic Ductal
/ drug therapy
Clinical Trials, Phase I as Topic
Clinical Trials, Phase II as Topic
Deoxycytidine
/ administration & dosage
Female
Follow-Up Studies
Humans
Male
Middle Aged
Paclitaxel
/ administration & dosage
Pancreatic Neoplasms
/ drug therapy
Prognosis
Research Design
Retrospective Studies
Survival Rate
Young Adult
Gemcitabine
Clinical protocol
Combination therapy
PD-1 blockade
Pancreatic ductal adenocarcinoma
Journal
BMC cancer
ISSN: 1471-2407
Titre abrégé: BMC Cancer
Pays: England
ID NLM: 100967800
Informations de publication
Date de publication:
09 Jul 2020
09 Jul 2020
Historique:
received:
11
05
2020
accepted:
01
07
2020
entrez:
11
7
2020
pubmed:
11
7
2020
medline:
11
3
2021
Statut:
epublish
Résumé
Pancreatic ductal adenocarcinoma (PDAC) is a fatal disease with a dismal response to single-use of immune checkpoint inhibitors (ICIs). ICIs combined with systemic therapy has shown efficacy and safety in various solid tumors. Nab-paclitaxel and gemcitabine (AG), as the standard first-line treatment for advanced PDAC, has been widely used in recent years. The combination of ICIs and AG chemotherapy appears to be a promising option in the treatment of PDAC. This is an open-label, single-arm, and single-center phase Ib/II trial. The enrolled subjects are the unresectable (locally advanced or metastatic) PDAC patients without previous systemic treatments. All subjects receive an intravenous injection of gemcitabine 1000 mg/m This trial is the first attempt to evaluate the efficacy and safety of the combination of toripalimab plus AG chemotherapy as a first-line treatment for unresectable PDAC patients. The results of this phase Ib/II study will provide preliminary evidence for further assessment of this combined therapeutic regimen for unresectable PDAC patients. Trial registration: ChiCTR ( ChiCTR2000032293 ). Registered 25 April 2020 - Retrospectively registered.
Sections du résumé
BACKGROUND
BACKGROUND
Pancreatic ductal adenocarcinoma (PDAC) is a fatal disease with a dismal response to single-use of immune checkpoint inhibitors (ICIs). ICIs combined with systemic therapy has shown efficacy and safety in various solid tumors. Nab-paclitaxel and gemcitabine (AG), as the standard first-line treatment for advanced PDAC, has been widely used in recent years. The combination of ICIs and AG chemotherapy appears to be a promising option in the treatment of PDAC.
METHODS
METHODS
This is an open-label, single-arm, and single-center phase Ib/II trial. The enrolled subjects are the unresectable (locally advanced or metastatic) PDAC patients without previous systemic treatments. All subjects receive an intravenous injection of gemcitabine 1000 mg/m
DISCUSSION
CONCLUSIONS
This trial is the first attempt to evaluate the efficacy and safety of the combination of toripalimab plus AG chemotherapy as a first-line treatment for unresectable PDAC patients. The results of this phase Ib/II study will provide preliminary evidence for further assessment of this combined therapeutic regimen for unresectable PDAC patients.
TRIAL REGISTRATION
BACKGROUND
Trial registration: ChiCTR ( ChiCTR2000032293 ). Registered 25 April 2020 - Retrospectively registered.
Identifiants
pubmed: 32646394
doi: 10.1186/s12885-020-07126-3
pii: 10.1186/s12885-020-07126-3
pmc: PMC7346390
doi:
Substances chimiques
130-nm albumin-bound paclitaxel
0
Albumins
0
Antibodies, Monoclonal, Humanized
0
Deoxycytidine
0W860991D6
toripalimab
8JXN261VVA
Paclitaxel
P88XT4IS4D
Gemcitabine
0
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
636Subventions
Organisme : National Natural Science Foundation of China
ID : 81773097
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