First-line Regimen With QL1706 Plus Chemo ± Bev in PDAC Patients

Pancreatic Cancer Clinical Trial

Official title: A Multicenter,Open-label,Exploratory Study of QL1706 Plus Nab-paclitaxel and Gemcitabine With or Without Bevacizumab as First-line Treatment in Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer

Status Not yet recruiting

Clinical Trial Summary

This is a multicenter, open-label, exploratory study to evaluate the efficacy and safety of QL1706 plus nab-paclitaxel and gemcitabine with or without bevacizumab as first-line treatment in patients with unresectable locally advanced or metastatic pancreatic cancer

Clinical Trial Description

This study is an open, multicenter, exploratory clinical trial designed to evaluate the efficacy and safety of QL1706 in combination with albumin paclitaxel and gemcitabine with or without bevacizumab for the first-line treatment of patients with unresectable locally advanced or metastatic pancreatic cancer.

The study was conducted in patients with unresectable locally advanced or metastatic pancreatic cancer who had not received prior systemic therapy. Subjects sign informed consent, undergo a screening period of examination and evaluation, which lasts for 21 days, and those who meet the entry criteria enter the treatment period and are randomized 1:1 to receive either QL1706 in combination with albumin paclitaxel and gemcitabine or to receive QL1706 in combination with albumin paclitaxel, gemcitabine, and bevacizumab in 3-week intervals until protocol-specified treatment termination Event. Subjects will be enrolled in the study and will undergo a safety visit prior to D1 dosing for each treatment cycle, please refer to the trial flow chart. Imaging exams and assessments will be performed every 6 weeks (± 7 days) for the first 24 weeks of treatment and every 9 weeks (± 7 days) thereafter until disease progression, initiation of new antitumor therapy, withdrawal of informed consent, or death, whichever occurs first, as confirmed per RECIST v1.1. Additional imaging and evaluation may be performed at any time during the study if clinically indicated.

Subjects will be required to complete safety examinations and imaging assessments at the end of treatment, followed by a safety visit and follow-up until 90 days after the last dose of QL1706 or 30 days after the last dose of other investigational agents, whichever is longer. For subjects who end treatment with non-RECIST v1.1 criteria for disease progression, imaging should be continued to assess time to tumor progression. Survival follow-up is performed after the safety visit, every 60 days (±7 days), to collect and record the subject's survival status and subsequent antitumor therapy.

The study used ORR as the primary endpoint and was planned to enroll 50 subjects, 25 in the QL1706 combined albumin paclitaxel and gemcitabine group and 25 in the QL1706 combined albumin paclitaxel and gemcitabine combined bevacizumab group. ;

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

• NCT number: NCT06313970
• Study type: Interventional
• Source: Fudan University
• Contact: Si Shi, MD
• Phone: +86-021-64179375
• Email: shisi@fudanpci.org
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: April 15, 2024
• Completion date: April 15, 2026