Ignite Creation Date:
2024-05-06 @ 1:34 PM
Last Modification Date:
2024-10-26 @ 1:16 PM
Study NCT ID:
NCT04060472
Status:
UNKNOWN
Last Update Posted:
2019-08-19
First Post:
2019-08-15
Brief Title:
Paclitaxel Albumin-bound and Oxaliplatin for Advanced Hepatobiliary and Malignant Tumors
Sponsor:
Dong Wang
Organization:
Third Military Medical University
Study Overview
Official Title:
Single-center Single-arm and Phase IIIII Clinical Study of Paclitaxel Albumin-binding Combined With Oxaliplatin as First-line Treatment for Advanced Hepatobiliary and Malignant Tumors
Status:
UNKNOWN
Status Verified Date:
2019-08
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
1 Advantages of albumin-bound paclitaxel Paclitaxel for injection albumin-binding type uses human serum albumin HAS as a carrier and paclitaxel and HSA are made into paclitaxel-bound albumin nanoparticles by a high-pressure homogenization technique After injection of paclitaxel albumin-binding into the blood it rapidly disintegrates and disperses into a smaller albumin-paclitaxel complex which binds and activates the gp60 albumin receptor on vascular endothelial cells interacts with Caveolin on the cell membrane and then is transported to the tumor intercellular substance by transcytosis Tumor cells can secrete a SPARC protein with a specific affinity for albumin which actively captures the albumin-paclitaxel complex in the tumor stroma and accumulates around the tumor cells Since tumor neovascular endothelial cells highly express gp60 receptor and the SPARC protein is also highly expressed in the tumor region the special transport mechanism of gp60- Caveolin caveola -SPARC protein makes the paclitaxel for injection albumin binding have unique targeting and penetrating properties toward tumor tissues hence the drug is highly concentrated in the tumor tissue which can better increase the therapeutic effect and reduce the damage to normal tissues
Paclitaxel for injection albumin-binding type has the following advantages 1 it is unnecessary to pre-administer anti-allergic drugs the infusion time is within 30 min and patients have good compliance 2 due to its higher safety the dosage can be given as high as 260-300 mgm2 3 it makes full use of gp60 cysteine acid secretory protein SPARC protein channel to make the drug enrich toward the tumor area and the effect is good 4 as the dosage is within 80 300 mgm2 the AUC increase proportionally with the administered dose the body is linearly metabolized the half-life period does not prolong with the dose and the clinical medication is safe and controllable Currently the drug has been approved for breast cancer treatment in China approved by the US Food and Drug Administration FDA for breast cancer lung cancer and pancreatic cancer treatment approved for gastric cancer treatment in Japan and NCCN guidelines recommend it for the treatment of intrahepatic cholangiocarcinoma melanoma ovarian cancer and cervical cancer
In summary based on the biological advantages of albumin-binding paclitaxel such as high-distribution high-dose high-efficiency and low-toxicity the reported good clinical benefit and safety for hepatobiliary and malignant tumors and the limited data about albumin-bound paclitaxel oxaliplatin as the first-line treatment for advanced hepatobiliary and pancreatic malignancies especially in Chinese patients our center believes that is feasible and necessary to explore the effectiveness and safety of paclitaxel for injection albumin-binding combined with oxaliplatin as the first-line drugs for treatment of advanced oxaliplatin-based malignant tumors
2 Purposes To evaluate the efficacy and safety of paclitaxel albumin-bound combined with oxaliplatin as the first-line drugs for treatment of advanced hepatobiliary and malignant tumors
Primary endpoint progression-free survival PFS Secondary study endpoints disease control rate DCR overall survival OS and incidence and severity of adverse events AE
3 Research plan 31 Research Design This study was a single-center one-arm phase IIIII clinical trial which plans to recruit 57 patients
Paclitaxel for injection albumin-binding type has the following advantages 1 it is unnecessary to pre-administer anti-allergic drugs the infusion time is within 30 min and patients have good compliance 2 due to its higher safety the dosage can be given as high as 260-300 mgm2 3 it makes full use of gp60 cysteine acid secretory protein SPARC protein channel to make the drug enrich toward the tumor area and the effect is good 4 as the dosage is within 80 300 mgm2 the AUC increase proportionally with the administered dose the body is linearly metabolized the half-life period does not prolong with the dose and the clinical medication is safe and controllable Currently the drug has been approved for breast cancer treatment in China approved by the US Food and Drug Administration FDA for breast cancer lung cancer and pancreatic cancer treatment approved for gastric cancer treatment in Japan and NCCN guidelines recommend it for the treatment of intrahepatic cholangiocarcinoma melanoma ovarian cancer and cervical cancer
In summary based on the biological advantages of albumin-binding paclitaxel such as high-distribution high-dose high-efficiency and low-toxicity the reported good clinical benefit and safety for hepatobiliary and malignant tumors and the limited data about albumin-bound paclitaxel oxaliplatin as the first-line treatment for advanced hepatobiliary and pancreatic malignancies especially in Chinese patients our center believes that is feasible and necessary to explore the effectiveness and safety of paclitaxel for injection albumin-binding combined with oxaliplatin as the first-line drugs for treatment of advanced oxaliplatin-based malignant tumors
2 Purposes To evaluate the efficacy and safety of paclitaxel albumin-bound combined with oxaliplatin as the first-line drugs for treatment of advanced hepatobiliary and malignant tumors
Primary endpoint progression-free survival PFS Secondary study endpoints disease control rate DCR overall survival OS and incidence and severity of adverse events AE
3 Research plan 31 Research Design This study was a single-center one-arm phase IIIII clinical trial which plans to recruit 57 patients
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None