A Study to Compare QLS31905 and Chemotherapy With Placebo and Chemotherapy in Participants With Pancreatic Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: QLS31905, Nab-paclitaxel., Gemcitabine, Placebo for QLS31905.
- Who it may be relevant to
- Registry conditions: Pancreatic Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Drug QLS31905
QLS31905 will be administered as an IV infusion. - Drug Nab-paclitaxel.
Nab-paclitaxel will be administered as an IV infusion. - Drug Gemcitabine
Gemcitabine will be administered as an IV infusion. - Drug Placebo for QLS31905
Placebo will be administered as an IV infusion. - Drug Nab-paclitaxel.
Nab-paclitaxel will be administered as an IV infusion - Drug Gemcitabine
Gemcitabine will be administered as an IV infusion.
Primary outcome measures
- Overall Suryival(OS) [Time frame: Up to 48 months]
Secondary outcome measures (4)
- Progression Free Survival (PFS) [Time frame: Up to 48 months]
- Objective Response Rate (ORR) [Time frame: Up to 48 months]
- Duration Of Response (DOR) [Time frame: Up to 48 months]
- Safety assessed by Adverse Events (AEs) [Time frame: Up to 48 months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Beijing Cancer Hospital — Beijing
Identifiers
NCT: NCT07079228 · QLS31905-301