Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06313970
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-03-11
Brief Title:
First-line Regimen With QL1706 Plus Chemo Bev in PDAC Patients
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
A MulticenterOpen-labelExploratory Study of QL1706 Plus Nab-paclitaxel and Gemcitabine With or Without Bevacizumab as First-line Treatment in Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
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:
This is a multicenter open-label exploratory study to evaluate the efficacy and safety of QL1706 plus nab-paclitaxel and gemcitabine with or without bevacizumab as first-line treatment in patients with unresectable locally advanced or metastatic pancreatic cancer
Detailed Description:
This study is an open multicenter exploratory clinical trial designed to evaluate the efficacy and safety of QL1706 in combination with albumin paclitaxel and gemcitabine with or without bevacizumab for the first-line treatment of patients with unresectable locally advanced or metastatic pancreatic cancer
The study was conducted in patients with unresectable locally advanced or metastatic pancreatic cancer who had not received prior systemic therapy Subjects sign informed consent undergo a screening period of examination and evaluation which lasts for 21 days and those who meet the entry criteria enter the treatment period and are randomized 11 to receive either QL1706 in combination with albumin paclitaxel and gemcitabine or to receive QL1706 in combination with albumin paclitaxel gemcitabine and bevacizumab in 3-week intervals until protocol-specified treatment termination Event Subjects will be enrolled in the study and will undergo a safety visit prior to D1 dosing for each treatment cycle please refer to the trial flow chart Imaging exams and assessments will be performed every 6 weeks 7 days for the first 24 weeks of treatment and every 9 weeks 7 days thereafter until disease progression initiation of new antitumor therapy withdrawal of informed consent or death whichever occurs first as confirmed per RECIST v11 Additional imaging and evaluation may be performed at any time during the study if clinically indicated
Subjects will be required to complete safety examinations and imaging assessments at the end of treatment followed by a safety visit and follow-up until 90 days after the last dose of QL1706 or 30 days after the last dose of other investigational agents whichever is longer For subjects who end treatment with non-RECIST v11 criteria for disease progression imaging should be continued to assess time to tumor progression Survival follow-up is performed after the safety visit every 60 days 7 days to collect and record the subjects survival status and subsequent antitumor therapy
The study used ORR as the primary endpoint and was planned to enroll 50 subjects 25 in the QL1706 combined albumin paclitaxel and gemcitabine group and 25 in the QL1706 combined albumin paclitaxel and gemcitabine combined bevacizumab group
The study was conducted in patients with unresectable locally advanced or metastatic pancreatic cancer who had not received prior systemic therapy Subjects sign informed consent undergo a screening period of examination and evaluation which lasts for 21 days and those who meet the entry criteria enter the treatment period and are randomized 11 to receive either QL1706 in combination with albumin paclitaxel and gemcitabine or to receive QL1706 in combination with albumin paclitaxel gemcitabine and bevacizumab in 3-week intervals until protocol-specified treatment termination Event Subjects will be enrolled in the study and will undergo a safety visit prior to D1 dosing for each treatment cycle please refer to the trial flow chart Imaging exams and assessments will be performed every 6 weeks 7 days for the first 24 weeks of treatment and every 9 weeks 7 days thereafter until disease progression initiation of new antitumor therapy withdrawal of informed consent or death whichever occurs first as confirmed per RECIST v11 Additional imaging and evaluation may be performed at any time during the study if clinically indicated
Subjects will be required to complete safety examinations and imaging assessments at the end of treatment followed by a safety visit and follow-up until 90 days after the last dose of QL1706 or 30 days after the last dose of other investigational agents whichever is longer For subjects who end treatment with non-RECIST v11 criteria for disease progression imaging should be continued to assess time to tumor progression Survival follow-up is performed after the safety visit every 60 days 7 days to collect and record the subjects survival status and subsequent antitumor therapy
The study used ORR as the primary endpoint and was planned to enroll 50 subjects 25 in the QL1706 combined albumin paclitaxel and gemcitabine group and 25 in the QL1706 combined albumin paclitaxel and gemcitabine combined bevacizumab group
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