Phase III Study Comparing TQB2868 Injection and Anlotinib Hydrochloride Capsules Plus Chemotherapy Versus Placebo Plus Chemotherapy for First-line Treatment of Metastatic Pancreatic Ductal Adenocarcinoma

What this Trial Is About

Researchers are investigating treatments for metastatic pancreatic ductal adenocarcinoma mPDAC in this randomized, double-blind, placebo-controlled, multicenter phase III clinical trial. The study aims to compare overall survival between patients receiving a combination of TQB2868 injection, anlotinib hydrochloride capsules, and chemotherapy versus those receiving placebo combined with chemotherapy. This trial evaluates whether adding TQB2868, a dual antibody targeting PD-L1 and TGF-beta, to standard treatment may impact survival outcomes in patients with advanced pancreatic cancer. Participants are randomly assigned to one of two groups. The experimental group receives TQB2868 injection plus anlotinib hydrochloride capsules combined with gemcitabine hydrochloride injection and paclitaxel for injection. The control group receives a placebo injection combined with anlotinib hydrochloride capsules and the same chemotherapy drugs. Treatments are given as first-line therapy for metastatic disease, with dosing and administration schedules based on the trial protocol. The study includes an approximately two-year period for measuring overall survival as the primary outcome. During the trial, participants will undergo regular assessments including imaging scans to evaluate tumor response, laboratory tests, and monitoring for adverse events. Secondary outcomes include progression-free survival, objective response rate, disease control rate, duration of response, and time to tumor recurrence, observed over about one year. Safety is closely monitored until 28 days after the last treatment. The total participation time varies depending on individual outcomes and follow-up schedules.

Clinical Trial Comparing TQB2868 Injection Combined With Anlotinib Hydrochloride Capsules With Placebo Combined With Chemotherapy as First-line Treatment for Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)