Ignite Creation Date:
2025-12-24 @ 11:59 AM
Ignite Modification Date:
2025-12-31 @ 8:06 AM
Study NCT ID:
NCT06750861
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-10
First Post:
2024-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
QL1706 Plus Chemotherapy With AG Regime as First-line Treatment of Advanced PDAC
Sponsor:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Organization:
Study Overview
Official Title:
QL1706 in Combination With Nab-paclitaxel and Gemcitabine as First-line Treatment in Patients With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma : A Single-arm, Phase II Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-02
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 single-center, open-label, exploratory study to evaluate the efficacy and safety of QL1706 plus nab-paclitaxel and gemcitabine as first-line treatment in patients with unresectable locally advanced or metastatic pancreatic ductal adenocarcinoma.
Detailed Description:
This study is an open, single-center, exploratory clinical trial designed to evaluate the efficacy and safety of QL1706 in combination with nab-paclitaxel and gemcitabine for the first-line treatment of patients with unresectable locally advanced or metastatic pancreatic ductal adenocarcinoma, 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 receive QL1706 in combination with albumin-paclitaxel and gemcitabine in 3-week intervals until protocol-specified treatment termination Event. Subjects will be enrolled in the study and wil undergo safety visit prior to D1 dosing for each treatment cycle. lmaging exams and assessments will be performed every 6 weeks (± 7 days) until disease progression, initiation of new anti-tumor therapy, withdrawal of informed consent, or death, whichever occurs first, as confirmed per REClST v1.1. Additional imaging and evaluation may be performed at any time during the study if clinically indicated.
Subjects wil 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. Survival follow-up is performed after the safety visit, every 60 days (±7 days), to collect and record the subject's survival status and subsequent anti-tumor therapy.The study used ORR as the primary endpoint and was planned to enroll 30 subjects.
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 receive QL1706 in combination with albumin-paclitaxel and gemcitabine in 3-week intervals until protocol-specified treatment termination Event. Subjects will be enrolled in the study and wil undergo safety visit prior to D1 dosing for each treatment cycle. lmaging exams and assessments will be performed every 6 weeks (± 7 days) until disease progression, initiation of new anti-tumor therapy, withdrawal of informed consent, or death, whichever occurs first, as confirmed per REClST v1.1. Additional imaging and evaluation may be performed at any time during the study if clinically indicated.
Subjects wil 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. Survival follow-up is performed after the safety visit, every 60 days (±7 days), to collect and record the subject's survival status and subsequent anti-tumor therapy.The study used ORR as the primary endpoint and was planned to enroll 30 subjects.
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?: