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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QL1706+AG | Experimental | 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 maintenance therapy, and the regimen is QL1706 monotherapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QL1706 | Drug | QL1706+AG |
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| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Median Progression-Free Survival (mPFS) | 1 year | |
| Median Overall Survival (mOS) | 2 years | |
| Duration of Response (DoR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lin Yang, Doctor | Contact | 13681015148 | linyangcicams@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College | Beijing | Chaoyang District | 100021 | China |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| 1 year |
| Disease Control Rate (DCR) | 1 year |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |