NCT07079228RecruitingPhase 3
A Study to Compare QLS31905 and Chemotherapy With Placebo and Chemotherapy in Participants With Pancreatic Cancer
A Phase 3, Multi-Center, Double-blind, Randomized Study of QLS31905 Plus Chemotherapy Versus Placebo Plus Chemotherapy as First-Line Treatment in Participants With Claudin (CLDN)18.2-Positive Advanced Pancreatic Cancer
Source: ClinicalTrials.gov · Last updated 23 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 602 (estimated)
- First submitted
- 13 Jul 2025
- Start date
- 8 Sept 2025
- Primary completion date
- Dec 2028
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Diseases
- Pancreatic cancer
- NCT number
- NCT07079228
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 602
- From 8 Sept 2025 to the primary completion date, Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Underwent major organ surgery (excluding needle biopsy) or had significant trauma within 28 days prior to enrollment, or requires elective surgery during the study;
Other illness
- History of malignancies other than the target cancer within 5 years prior to the first dose of the investigational product ;
- 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;
Other
- Known central nervous system metastases;
- 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.
Who the study is looking for
- 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 ≥ 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Cancer Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.