Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT06313970

First-line Regimen With QL1706 Plus Chemo ± Bev in PDAC Patients

Led by Fudan University · Updated on 2025-09-03

58

Participants Needed

1

Research Sites

123 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a multicenter, open-label, exploratory study to evaluate the efficacy and safety of QL1706 plus nab-paclitaxel and gemcitabine with or without bevacizumab as first-line treatment in patients with unresectable locally advanced or metastatic pancreatic cancer

CONDITIONS

Official Title

First-line Regimen With QL1706 Plus Chemo ± Bev in PDAC Patients

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Voluntarily agree to participate and sign informed consent
  • Age between 18 and 75 years
  • Confirmed diagnosis of pancreatic ductal adenocarcinoma or adenocarcinoma by histology or cytology
  • No prior systemic therapy for unresectable locally advanced or metastatic pancreatic cancer
  • At least one measurable tumor lesion according to RECIST 1.1 criteria
  • ECOG Performance Status of 0 or 1
  • Estimated life expectancy of 3 months or more
  • Adequate major organ function without recent use of blood component or cell growth factor therapy within 14 days before randomization
  • Women of child-bearing potential must agree to use effective contraception from consent until at least 120 days after last study drug dose, have a negative HCG test, and not be breastfeeding
  • Male participants with partners of child-bearing potential must agree to use effective contraception and not donate sperm from consent until at least 120 days after last study drug dose
Not Eligible

You will not qualify if you...

  • Other types of pancreatic cancer such as acinar cell carcinoma, neuroendocrine tumors, or pancreatoblastoma
  • History of other cancers within 5 years except cured localized tumors
  • Active or untreated brain metastases, meningeal metastases, spinal cord compression, or leptomeningeal disease
  • History of life-threatening bleeding or high bleeding risk within 6 months before randomization
  • Major trauma or surgery within 28 days before randomization or planned major surgery during the study
  • Poorly controlled high blood pressure or history of hypertensive crisis or encephalopathy
  • Thrombotic or embolic events like stroke, deep vein thrombosis, or pulmonary embolism within 6 months before randomization
  • Prior treatments targeting tumor immunity such as immune checkpoint therapies or immune cell therapy
  • Active autoimmune disease requiring systemic treatment within 2 years or diseases that may relapse requiring scheduled treatment
  • Active hepatitis B or C infection
  • Known immunodeficiency or HIV positive status
  • Investigator's judgment that participation is not appropriate

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fudan University Shanghai Cancer Center

Shanghai, China

Actively Recruiting

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Research Team

S

Si Shi, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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