NCT07110064 QL1706+Lenvatinib+AG Regimen as First-line Treatment for Advanced Metastatic Pancreatic Cancer
| NCT ID | NCT07110064 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Du Juan |
| Condition | Advance Pancreatic Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-09-03 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 80 participants in total. It began in 2025-09-03 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * a. Age ≥18 years, ECOG performance status ≤2, and expected survival of ≥3 months. * b. Patients with histologically or cytologically confirmed advanced metastatic pancreatic cancer. * c. At least one measurable lesion according to RECIST 1.1 criteria; * d. No prior anti-tumor treatment of any kind. * e. Patients must meet the following hematological criteria: e1. White blood cell count (WBC) ≥3.0×10\^9/L; e2. Absolute neutrophil count (ANC) ≥1.5×10\^9/L; e3. Hemoglobin (HB) ≥90 g/L; e4. Platelet count (PLT) ≥75×10\^9/L; e5. Total bilirubin (TBIL) ≤1.5× upper limit of normal (ULN); e6. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN; if there is liver metastasis, then ALT and AST ≤5×ULN; e7. Serum creatinine (Cr) ≤1×ULN or creatinine clearance (CCr) ≥50 ml/min; * f. Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) ≥ lower limit of normal (50%). * g. Patients of childbearing potential must take appropriate protective measures (contraception or other methods of fertility control) before enrollment and during the study. * h. Willingness to participate in the study, with signed informed consent, good compliance, and cooperation with follow-up; able to adhere to the study protocol and follow-up procedures. Exclusion Criteria: * a. Prior receipt of systemic anti-tumor treatment, such as chemotherapy, radiotherapy, or other anti-tumor treatments. * b. Participation in another drug clinical trial within the past 4 weeks. * c. Subjects who, in the investigator's judgment, have the opportunity for surgery or are potentially operable (subjects who voluntarily forgo surgical treatment may be enrolled after investigator assessment and agreement). * d. Subjects with moderate ascites requiring drainage (except for those with minimal ascites shown on imaging without symptoms). * e. Known symptomatic central nervous system metastases and/or carcinomatous meningitis. * f. History of other primary malignancies, except for the following: 1) Malignancies that have been in complete remission for at least 2 years prior to enrollment and do not require other treatments during the study; 2) Non-melanoma skin cancer or malignant lentigo that has been adequately treated and shows no evidence of disease recurrence; 3) Carcinoma in situ that has been adequately treated and shows no evidence of disease recurrence. * g. Patients with autoimmune diseases or immune deficiencies who are being treated with immunosuppressive drugs. * h. Patients with a tendency to bleed. * i. Pregnant or breastfeeding women. Women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment. * j. Drug abuse, or clinical, psychological, or social factors that may affect informed consent or study implementation. * k. Subjects who may be allergic to epaltrastide (QL1706), lenvatinib, albumin-bound paclitaxel, or gemcitabine.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07110064 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advance Pancreatic Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07110064 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07110064 currently recruiting?
Yes, NCT07110064 is actively recruiting participants. Contact the research team at dujuanglyy@163.com for enrollment information.
Where is the NCT07110064 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT07110064 clinical trial?
NCT07110064 is sponsored by Du Juan. The trial plans to enroll 80 participants.
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