QLS31905 plus chemotherapy versus placebo plus chemotherapy for CLDN18.2-positive advanced pancreatic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 trial compares QLS31905 combined with nab-paclitaxel and gemcitabine to placebo with the same chemotherapy in adults with CLDN18.2-positive unresectable locally advanced or metastatic pancreatic cancer. Eligible participants must have histologic or cytologic confirmation, measurable disease by RECIST v1.1, ECOG performance status 0–1, no prior systemic therapy for advanced disease, and adequate organ function. Participants are assigned to receive the study drug or placebo alongside standard chemotherapy and are followed for tumor response, survival outcomes, and safety measurements. The trial is conducted at Beijing Cancer Hospital and requires informed consent and regular clinic visits for treatment and monitoring.

Why it matters

Who can join: the full rules

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.

Where it's running

• Beijing Cancer Hospital
  Beijing, China Recruiting

Study contacts

• Study coordinator: Lin Shen, M.D
• Email: linshenpku@163.com
• Phone: 010-88196561

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Integrated genomic and clinical database for cancer biomarker discovery

  Researchers are building a combined genomic and clinical database at Samsung Medical Center to test biomarkers for cancer diagnosis, treatment choice, and predicting how well treatments work.

  Recruiting Samsung Medical Center · Seoul, Gang-Nam · NCT07911267

• Using contrast-enhanced ultrasound to check for local pancreatic cancer recurrence after surgery

  This pilot test uses contrast-enhanced ultrasound to see if it can help detect return of pancreatic cancer after surgery in patients being watched with CT scans.

  Recruiting Thomas Jefferson University · Philadelphia, Pennsylvania · NCT07910383

• Combination of ivermectin with standard skin-protective care for daraxonrasib-related skin toxicity in pancreatic cancer

  This study tests whether adding ivermectin to standard preventive skin care helps people with pancreatic cancer who develop skin side effects from daraxonrasib.

  Recruiting at 7 sites Phase 2 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07895498

• Becotatug Vedotin Plus Anti-PD-1 and S-1 in EGFR-Positive Advanced Pancreatic Cancer

  This study tests a three-drug regimen (becotatug vedotin, an anti-PD-1 therapy, and S-1) in adults with EGFR-positive advanced pancreatic cancer who have not responded to at least one prior therapy.

  Recruiting Ningbo Medical Center Lihuili Hospital · Ningbo, Zhejiang · NCT07892573

• Blood protein biomarkers to help diagnose pancreatic cancer in adults

  This study tests whether blood protein biomarkers can help detect pancreatic ductal adenocarcinoma and tell it apart from chronic pancreatitis and mucinous pancreatic lesions, and whether combining markers with CA 19-9 improves accuracy.

  Recruiting Grigore T. Popa University of Medicine and Pharmacy · Iași · NCT07875582

• Lm-LLO-TT and Gemcitabine in Unresectable Pancreatic Cancer (Phase 1)

  This early-stage study tests whether giving Lm-LLO-TT directly into the belly with low-dose gemcitabine is safe and tolerable for adults with previously treated, unresectable or metastatic pancreatic cancer.

  Recruiting Phase 1 Matter Bio, Inc. · The Bronx, New York · NCT07828236

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.