Actively Recruiting
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
Eligibility Criteria
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.
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
Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, China
Actively Recruiting
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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