QL1706 Plus Chidamide, AG as First-line Treatment for Metastatic Pancreatic Cancer

Tianjin Medical University

Status and phase

Enrolling

Phase 2

Conditions

Metastatic Pancreatic Cancer

Treatments

Drug: Gemcitabine

Drug: Chidamide

Drug: QL1706

Drug: Nab-paclitaxel

Study type

Interventional

Funder types

Other

Identifiers

NCT06951997

QL-PC-QIBA-3002

Details and patient eligibility

About

This is a single-center, open-label, exploratory study aims to assess the efficacy and safety of QL1706 plus nab-paclitaxel and gemcitabine as first-line treatment for patients with metastatic pancreatic adenocarcinoma.

Enrollment

33 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Understand and voluntarily sign the informed consent form for this study
Age ≥18 years and ≤ 75 years, ale or Female
Histologically or cytologically confirmed diagnosis of pancreatic cancer (originating from the pancreatic ductal epithelium), with clinical records showing metastatic pancreatic cancer (stage IV according to the AJCC 8th edition TNM staging of pancreatic cancer)
No prior anti-tumor treatment (radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.) received
At least one measurable lesion on imaging according to RECIST 1.1
ECOG score 0-1
Expected survival time ≥3 months
Adequate organ function, subjects must meet the following laboratory criteria:Platelet count ≥90x10^9/L,White blood cell count ≥ 3.5 × 10⁹/L,Absolute neutrophil count (ANC) ≥1.5x10^9/L,Hemoglobin > 90g/L,Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times ULN,Total bilirubin ≤ 1.5 ULN,Urea/Urea nitrogen (BUN) and creatinine (Cr) ≤ 1.5 × ULN (and creatinine clearance rate (CCr) ≥ 50 mL/min),Left ventricular ejection fraction (LVEF) ≥ 50%,QTcF interval (Fridericia correction) < 470 ms
Fertile women/non-sterilized men must use effective contraception

Exclusion criteria

Inability to comply with the study protocol or procedures
patients with pancreatic cancer originating from non-pancreatic ductal epithelium, including pancreatic neuroendocrine carcinoma, pancreatic follicular cell carcinoma, pancreatoblastoma, and solid-pseudopapillary tumors
Known presence of germline BRCA1/2 mutations
patients with known central nervous system metastases
Hypersensitivity or allergic predisposition to the study drug or its excipients
Concurrent use of any other investigational drug or participation in another clinical trial involving investigational therapy within 4 weeks
Major surgery, severe traumatic injury, fractures, or ulcers within 6 weeks before study
History of gastrointestinal perforation or fistula within 6 months before the first dose. Subjects may be enrolled if the perforation/fistula has been surgically repaired and the investigator confirms resolution
Clinically significant gastrointestinal disorders, including obstruction (including partial), dysphagia, malabsorption syndrome, or uncontrolled nausea, vomiting, diarrhea, or other conditions severely affecting nutrient absorption
Clinically significant bleeding or clear bleeding tendency within 1 month before the first dose, e.g.,gastrointestinal bleeding, hemorrhagic gastric ulcer
Any of the following concurrent conditions:(1) Uncontrolled hypertension, coronary artery disease, arrhythmia, or heart failure(2) Severe uncontrolled concurrent infection causing disability(3) Proteinuria ≥ 2+ (≥1.0 g/24 h)(4) Bleeding tendency or history within 2 months before enrollment, regardless of severity(5) Arterial/venous thromboembolic events within 12 months before treatment (e.g., cerebrovascular accident, transient ischemic attack)(6) Acute myocardial infarction, acute coronary syndrome, or CABG within 6 months before treatment(7) Unhealed fractures or chronic wounds(8) Coagulopathy, bleeding tendency, or ongoing anticoagulation therapy
History of other malignancies within 5 years before enrollment, except for adequately treated basal/squamous cell skin cancer or cervical carcinoma in situ
Any cardiovascular or cerebrovascular disease or risk factors
Active autoimmune disease or history of autoimmune disease within 4 weeks before enrollment
Prior allogeneic bone marrow or solid organ transplantation
Unresolved toxicities (> CTCAE v5.0 Grade 1) from prior anticancer therapy, except alopecia, lymphopenia, and oxaliplatin-induced neurotoxicity (≤ Grade 2)
Prior treatment with immune checkpoint inhibitors (e.g., anti-PD-1/PD-L1/CTLA-4 antibodies), immune checkpoint agonists (e.g., anti-ICOS/CD40/CD137/GITR/OX40 antibodies), or immune cell therapy (e.g., CAR-T)
Systemic treatment with corticosteroids (>10 mg/day prednisone or equivalent) or other immunosuppressants within 14 days before the first dose
Known interstitial lung disease (ILD) or non-infectious pneumonitis (either symptomatic or requiring systemic steroids)
Any other clinically significant condition, metabolic disorder, physical/lab abnormality, epilepsy requiring treatment etal
Pregnant or breastfeeding women
Any other condition deemed unsuitable for study participation by the investigator