QL1706 Plus Chidamide for Metastatic Pancreatic Cancer
QL1706 Plus Chidamide, AG as First-line Treatment for Metastatic Pancreatic Cancer
Recruiting
Phase 2Interventional Study
Metastatic Pancreatic Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
33 (estimated)
Sponsor
Tianjin Medical University Cancer Institute and Hospital · Other
Who this trial is looking for
This trial is looking for patients with advanced pancreatic cancer who haven't received treatment yet. Participants will receive QL1706 along with other approved medications to see how effective this combination is.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 75 years old.
I have been diagnosed with metastatic pancreatic cancer.
I have at least one measurable tumor.
I have not had any prior cancer treatments.
I can sign the consent form for this study.
I have a good overall health status (ECOG score 0-1).
I have a life expectancy of at least 3 months.
I use effective contraception if I am a fertile woman or non-sterilized man.
You may not be able to join if
I have other types of pancreatic cancer, like neuroendocrine tumors.
I have known brain metastases.
I have a severe allergic reaction to the study drug.
I have had major surgery or serious injury in the last 6 weeks.
I have a history of gastrointestinal perforation or fistula in the last 6 months.
I have uncontrolled bleeding or a clear tendency to bleed.
I have an active autoimmune disease.
I am pregnant or breastfeeding.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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Eligibility Criteria
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 …
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
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