A Study to Compare QLS31905 and Chemotherapy With Placebo and Chemotherapy in Participants With Pancreatic Cancer
NCT ID: NCT07079228
Last Updated: 2025-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
602 participants
INTERVENTIONAL
2025-09-08
2030-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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QLS31905 + nab-paclitaxel + gemcitabine (AG)
QLS31905
QLS31905 will be administered as an IV infusion.
Nab-paclitaxel.
Nab-paclitaxel will be administered as an IV infusion.
Gemcitabine
Gemcitabine will be administered as an IV infusion.
Placebo + nab-paclitaxel + gemcitabine (AG)
Placebo for QLS31905
Placebo will be administered as an IV infusion.
Nab-paclitaxel.
Nab-paclitaxel will be administered as an IV infusion
Gemcitabine
Gemcitabine will be administered as an IV infusion.
Interventions
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QLS31905
QLS31905 will be administered as an IV infusion.
Nab-paclitaxel.
Nab-paclitaxel will be administered as an IV infusion.
Gemcitabine
Gemcitabine will be administered as an IV infusion.
Placebo for QLS31905
Placebo will be administered as an IV infusion.
Nab-paclitaxel.
Nab-paclitaxel will be administered as an IV infusion
Gemcitabine
Gemcitabine will be administered as an IV infusion.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Qilu Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Beijing Cancer Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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QLS31905-301
Identifier Type: -
Identifier Source: org_study_id
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