Clinical trial for Advance Pancreatic Cancer
Official title QL1706+Lenvatinib+AG Regimen as First-line Treatment for Advanced Metastatic Pancreatic Cancer
ClinicalTrials.gov ID: NCT07110064
What this study is testing
What is QL1706+Lenvatinib+AG Regimen?
QL1706+Lenvatinib+AG Regimen is an investigational medicine, being studied as a potential treatment for advance pancreatic cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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)...
You likely can't join if
- 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. people who, in the investigator's judgment, have the opportunity for surgery or are potentially operable (people who voluntarily forgo surgical...
- d. people 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...
See the full eligibility 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)...
- 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.
- 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. people who, in the investigator's judgment, have the opportunity for surgery or are potentially operable (people who voluntarily forgo surgical treatment may be enrolled after investigator assessment and agreement).
- d. people 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)...
- 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. people who may be allergic to epaltrastide (QL1706), lenvatinib, albumin-bound paclitaxel, or gemcitabine.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.