A Study to Compare QLS31905 and Chemotherapy With Placebo and Chemotherapy in Participants With Pancreatic Cancer

Recruiting Phase 3 Interventional Study
Pancreatic Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
602 (estimated)
Sponsor
Qilu Pharmaceutical Co., Ltd. · Industry
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About This Trial

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.

Trial Locations
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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 …
Contacts

Lin Shen, M.D

010-88196561

linshenpku@163.com

CONTACT

Jihui Hao, M.D

022-23340123-3070

haojihui@tjmuch.com

CONTACT