Actively Recruiting
QL1706+Lenvatinib+AG Regimen as First-line Treatment for Advanced Metastatic Pancreatic Cancer
Led by Du Juan · Updated on 2026-01-02
80
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The investigators plan to initiate a prospective, multicenter, phase II study, recruiting 80 patients with advanced pancreatic cancer who have not received prior treatment. This study aims to enhance the anti-tumor immune effect through the combination of QL1706+Lenvatinib+AG regimen, thereby improving the prognosis of patients with advanced metastatic pancreatic cancer.
CONDITIONS
Official Title
QL1706+Lenvatinib+AG Regimen as First-line Treatment for Advanced Metastatic Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 and expected survival of at least 3 months
- Histologically or cytologically confirmed advanced metastatic pancreatic cancer
- At least one measurable tumor lesion based on RECIST 1.1 criteria
- No prior anti-tumor treatment of any kind
- Hematological requirements including WBC count ≥3.0×10^9/L, ANC ≥1.5×10^9/L, hemoglobin ≥90 g/L, platelet count ≥75×10^9/L
- Liver function within limits: total bilirubin ≤1.5×ULN, ALT and AST ≤2.5×ULN (or ≤5×ULN if liver metastases)
- Kidney function with serum creatinine ≤1×ULN or creatinine clearance ≥50 ml/min
- Left ventricular ejection fraction (LVEF) at or above lower normal limit (≥50%) by Doppler ultrasound
- Women of childbearing potential must use effective contraception or fertility control methods during the study
- Willingness to participate, provide informed consent, comply with study procedures, and attend follow-up visits
You will not qualify if you...
- Prior systemic anti-tumor treatment such as chemotherapy, radiotherapy, or other therapies
- Participation in another drug clinical trial within the past 4 weeks
- Candidates for surgery or potentially operable cases unless voluntarily declining surgery after investigator approval
- Moderate ascites requiring drainage (except minimal, asymptomatic ascites shown on imaging)
- Known symptomatic central nervous system metastases or carcinomatous meningitis
- History of other primary cancers except those in complete remission for 2 years, treated non-melanoma skin cancer, or treated carcinoma in situ without recurrence
- Autoimmune diseases or immune deficiencies treated with immunosuppressive drugs
- Bleeding tendency
- Pregnant or breastfeeding women; women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment
- Drug abuse or psychological/social conditions affecting consent or study participation
- Allergies to epaltrastide (QL1706), lenvatinib, albumin-bound paclitaxel, or gemcitabine
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Nanjing Drum Tower Hospital
Nanjing, China
Actively Recruiting
Research Team
J
Juan Du
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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