Recruiting NCT07110064
QL1706+Lenvatinib+AG Regimen as First-line Treatment for Advanced Metastatic Pancreatic Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: QL1706+Lenvatinib+AG Regimen.
- Who it may be relevant to
- Registry conditions: Advance Pancreatic Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Iparomlimab and Tuvonralimab Injection (QL1706) in Combination With Lenvatinib and AG Regimen as First-line Treatment for Advanced Metastatic Pancreatic Cancer:A Prospective, Single-Arm, Multicenter, Phase II Clinical Study
Overview
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.
Interventions
- Drug QL1706+Lenvatinib+AG Regimen
Participants will receive QL1706 combination with Lenvatinib and AG regimen for 8 cycles. Subsequently, the enrolled patients will continue to receive maintenance therapy with QL1706 and Lenvatinib until disease progression (PD) is observed, intolerable adverse events occur, or the investigator deems it inappropriate for the subject to continue treatment.
Primary outcome measures
- Median Progression-Free Survival (mPFS) [Time frame: up to 24 months]
Secondary outcome measures (4)
- Objective Response Rate (ORR) [Time frame: up to 24 months]
- Disease Control Rate (DCR) [Time frame: up to 24 months]
- Median Overall Survival (mOS) [Time frame: up to 24 months]
- Adverse Events（AEs） [Time frame: up to 36 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Nanjing Drum Tower Hospital — Nanjing
Identifiers
NCT: NCT07110064 · 2025-0462-02