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New hope for pancreatic cancer: targeted drug combo enters final trial phase

NCT ID NCT07079228

Disease control Sponsor: Qilu Pharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This Phase 3 trial is testing whether adding an experimental drug called QLS31905 to standard chemotherapy helps people with advanced pancreatic cancer live longer. The study includes 602 adults whose tumors have a specific marker (CLDN18.2). Participants are randomly assigned to receive either QLS31905 or a placebo, both combined with chemotherapy. The main goal is to see if the drug improves overall survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
QLS31905 (an experimental drug) plus chemotherapy (nab-paclitaxel and gemcitabine)
What this could lead to
If it works, this could provide a new first-line treatment option for people with a specific type of advanced pancreatic cancer, potentially extending survival.
What could go wrong
This is an early-stage Phase 3 trial, so results are not yet known. The drug may not improve survival or could cause side effects like infusion reactions or increased toxicity from chemotherapy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 602 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Sep 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

malignant pancreatic neoplasm pancreatic neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pancreatic cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beijing Cancer Hospital

    RECRUITING

    Beijing, China

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