2025-02-15
2026-06-30
2026-12-31
30
NCT06750861
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
INTERVENTIONAL
QL1706 Plus Chemotherapy With AG Regime as First-line Treatment of Advanced PDAC
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates | Results Reporting Dates | Study Record Updates |
---|---|---|
2024-12-20 | N/A | 2025-02-07 |
2024-12-20 | N/A | 2025-02-10 |
2024-12-27 | N/A | 2025-02 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: QL1706+AG QL1706+AG Every 3 weeks as a cycle: QL1706: 5mg/kg, IV, D3; Q3W Nab-paclitaxel: 125mg/m2, IV,D1、8; Q3W Gemcitabine: 1000mg/m2,IV,D1、8; Q3W Re-evaluate patients every two cycles. If the patient has been treated for more than 8 cycles, they will enter mai | DRUG: QL1706
|
Primary Outcome Measures | Measure Description | Time Frame |
---|---|---|
Objective Response Rate (ORR) | ORR of regimen of QL1706+AG | 1 year |
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | The incidence and severity (graded by CTCAE 5.0) of treatment emergent adverse events (TEAEs) and treatment-related adverse events (TRAEs), immune-related adverse events ( irAEs). | 1 year |
Secondary Outcome Measures | Measure Description | Time Frame |
---|---|---|
Median Progression-Free Survival (mPFS) | 1 year | |
Median Overall Survival (mOS) | 2 years | |
Duration of Response (DoR) | 1 year | |
Disease Control Rate (DCR) | 1 year |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact Name: Lin Yang, Doctor Phone Number: 13681015148 Email: linyangcicams@126.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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