Rui Liu
Tianjin, Tianjin Municipality, 300000, China
Location status: Recruiting
NCT Number: NCT05035147
This study aims to further observe and evaluate whether the three-week administration of albumin-bound paclitaxel combined with gemcitabine is equivalent to the four-week administration in the treatment of inoperable locally advanced or metastatic pancreatic cancer
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 4
Tianjin, Tianjin Municipality, 300000, China
Location status: Recruiting
Pancreatic cancer is a common clinical malignant tumor of the digestive system, and its incidence is gradually increasing worldwide.The prognosis is poor and the mortality rate is high, accounting for about 7% of cancer deaths.Albumin-bound paclitaxel is a good first-line treatment for pancreatic cancer. It has the advantages of high dose, high tumor tissue distribution, high efficacy, and low toxicity.It is hoped that the low-dose intensity can achieve the same clinical efficacy as the high-dose intensity, which provides strong evidence for the clinical choice of low-dose intensity.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Experimental:Albumin-bound paclitaxel combined with gemcitabine was administered on the first and eighth day, a cycle of three weeks Active Comparator: Albumin-bound paclitaxel combined with gemcitabine was administered on the first, eighth, and fifteenth days, with a four-week cycle
Other names: gemcitabine
Time frame: through study completion, an average of 5year
From date of randomization until the date of first documented progression or date of death from any cause
Time frame: through study completion, an average of 5year
The percentage of confirmed complete remission, partial remission and stable disease among patients with evaluable efficacy
Time frame: through study completion, an average of 5year
The proportion of patients whose tumors have shrunk to a certain level and maintained for a certain period of time, including CR and PR cases.The solid tumor response assessment standard (RECIST 1.1 standard) was used to assess the objective tumor response.The subject must have measurable tumor lesions at baseline.According to the RECIST 1.1 standard, the efficacy evaluation criteria are divided into complete remission (CR), partial remission (PR), stable (SD), and progress (PD)
Time frame: through study completion, an average of 5year
From date of randomization until the date of death from any cause
Contact information is provided by the study sponsor or research team.
Ji zhi, professor
CONTACT
Liu rui, professor
CONTACT
Tianjin Medical University Cancer Institute and Hospital
Other
Non-inferiority Study of Albumin-bound Paclitaxel Combined With Gemcitabine for Three Weeks Versus Four Weeks for First-line Inoperable Locally Advanced or Metastatic Pancreatic Cancer
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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