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Phase 2
Age: 18Years - 75Years
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ID06962267

Phase II Study of TQB2916 Injection Combined with Gemcitabine and Albumin-Paclitaxel as First Treatment for Metastatic Pancreatic Cancer

Led by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. · Updated on 2025-05-08

50

Participants Needed

1

Research Sites

8 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a combination treatment using TQB2916 injection with gemcitabine and albumin-paclitaxel as the first-line therapy for adults with metastatic pancreatic cancer. This study is a Phase II clinical trial designed to assess this new treatment approach in patients who have not received prior systemic anti-tumor therapy. The trial is sponsored by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd., and focuses on improving outcomes in this advanced cancer. The treatment involves giving TQB2916 injection combined with chemotherapy drugs, gemcitabine and albumin-paclitaxel, in 28-day cycles. Patients receive this combination as their initial therapy for metastatic pancreatic cancer. The study does not include a comparison or placebo group and uses an open-label design where both patients and researchers know the treatment being given. Participants will be monitored for up to 12 months to evaluate various outcomes including the rate of progression-free survival at 6 months, objective remission, disease control, event-free survival, overall survival, duration of response, adverse events, and immune response. Assessments will include clinical evaluations and safety monitoring throughout the study period. The goal is to gather comprehensive data on the treatments effects and safety profile during and after the treatment cycles.

CONDITIONS

Brief Title

A Clinical Study on the First-line Treatment of Metastatic Pancreatic Cancer With TQB2916 Injection Combined With Gemcitabine Hydrochloride for Injection and Paclitaxel for Injection (Albumin-bound Type)

Research Team

Y

Yi Ba, Doctor

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