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Metastatic Pancreatic CancerPhase 2NCT06951997

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

A Phase 2 study testing QL1706, Chidamide and Gemcitabine in people with Metastatic Pancreatic Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Metastatic Pancreatic Cancer
What is being tested?
QL1706, Chidamide and Gemcitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteChina
Study dates
7 Mar 2025to 31 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Rui Liu, MD contact

13602139003

liurui9003@163.com

China1 site, 1 recruiting

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin

    Rui Liu, MD, liurui9003@163.com

    Recruiting

Other trials in China

About this study

Official title: 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

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.

Being tested
QL1706, Chidamide, Gemcitabine, Nab-paclitaxel
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06951997
Study groupRoleWhat they receive
QL1706, Chidamide, Albumin-bound Paclitaxel and GemcitabineExperimentalQL1706 5mg/kg，Q3W; Gemcitabine 1000mg/m2 Q3W；Nab-paclitaxel 125mg/m2 Q3W; Chidamide, 20mg biw q3w;
Receives: Drug: QL1706; Drug: Chidamide; Drug: Gemcitabine; Drug: Nab-paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ORR

    overall response rate

    Measured: 1 year

Secondary outcomes (5)

  1. OS

    OS is defined as the time from date of treatment start to the date of death from any cause or to the date of last follow-up if patients are alive. If a patient is alive by the time of final analysis, the patient will be censored at the last follow-up date.

    Measured: 2 year

  2. AEs

    Defined as the proportion of patients with AE, treatment-related AE (TRAE), immune-related AE (irAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0

    Measured: 2 year

  3. Progression-free Survival (PFS)

    PFS was assessed by investigators per RECIST 1.1

    Measured: 2 year

  4. Disease Control Rate (DCR)

    DCR was assessed by investigators per RECIST 1.1

    Measured: 2 year

  5. Duration of Response (DOR)

    DOR was assessed by investigators per RECIST 1.1

    Measured: 2 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2025
  2. Study start7 Mar 2025
  3. Primary completion15 May 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
33 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06951997
Sponsor's protocol ID
QL-PC-QIBA-3002
Status last verified
Mar 2025
First submitted
23 Apr 2025
Last updated
26 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing QL1706, Chidamide and Gemcitabine in people with Metastatic Pancreatic Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Rui Liu, MD (13602139003, liurui9003@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06951997.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.

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