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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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

Clinical Study on the Efficacy and Safety of Iparomlimab and Tuvonralimab Injection Combined With Chidamide, Albumin-bound Paclitaxel and Gemcitabine as First-line Treatment for Metastatic Pancreatic Cancer

QL1706 Plus Chidamide, AG as First-line Treatment for Metastatic Pancreatic Cancer (NCT06951997) is a Phase 2 interventional studying Metastatic Pancreatic Cancer, sponsored by Tianjin Medical University Cancer Institute and Hospital. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Metastatic Pancreatic Cancer and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 33 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - Understand and voluntarily sign the willing to sign a consent form form for this study - Age ≥18 years and ≤ 75 years, ale or Female - diagnosed by tissue sample (biopsy-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 - your organs (liver, kidneys, etc.) are working well enough based on blood tests, 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 Who Should NOT Join This Trial: - 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 cancer that has spread to the brain - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

QL1706

5mg/kg, q3w

DRUG

Chidamide

20mg, biw, q3w

DRUG

Gemcitabine

1000mg/m2 Q3W

DRUG

Nab-paclitaxel

125mg/m2 Q3W

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Tianjin Medical University Cancer Institute and Hospital
Tianjin, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06951997), the sponsor (Tianjin Medical University Cancer Institute and Hospital), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06951997 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06951997?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06951997?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06951997. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06951997. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.