Actively Recruiting

Phase 3
Age: 18Years - 75Years
All Genders
NCT07079228

A Study to Compare QLS31905 and Chemotherapy With Placebo and Chemotherapy in Participants With Pancreatic Cancer

Led by Qilu Pharmaceutical Co., Ltd. · Updated on 2025-09-23

602

Participants Needed

1

Research Sites

259 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this study is to evaluate the efficacy of QLS31905 in combination with chemotherapy (nab-paclitaxel plus gemcitabine \[AG\]) versus placebo in combination with chemotherapy (AG) in the treatment of CLDN18.2-positive advanced pancreatic cancer in adult participants.

CONDITIONS

Official Title

A Study to Compare QLS31905 and Chemotherapy With Placebo and Chemotherapy in Participants With Pancreatic Cancer

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Subjects voluntarily participate in the study and sign the informed consent form
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1
  • Expected survival time 23 3 months
  • Histologically or cytologically confirmed diagnosis of pancreatic cancer
  • No prior systemic anti-tumor treatment for unresectable locally advanced or metastatic disease
  • At least one measurable lesion per RECIST v1.1
  • Patients with adequate cardiac, liver, renal function, etc.
Not Eligible

You will not qualify if you...

  • History of malignancies other than the target cancer within 5 years prior to the first dose of the investigational product
  • Underwent major organ surgery (excluding needle biopsy) or had significant trauma within 28 days prior to enrollment, or requires elective surgery during the study
  • Known central nervous system metastases
  • Patients with hepatitis B; patients with hepatitis C; patients who test positive for syphilis, or patients with a known history of HIV or positive HIV screening test
  • Patients with added risks associated with the study or may interfere with the interpretation of study results as determined by the investigator, or deemed unsuitable by the investigator

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

Beijing Cancer Hospital

Beijing, China

Actively Recruiting

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Research Team

L

Lin Shen, M.D

CONTACT

J

Jihui Hao, M.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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