RecruitingPhase 2NCT06962267

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)

A Phase II Clinical Study to Evaluate the Efficacy and Safety of TQB2916 Injection Combined With Gemcitabine and Albumin-paclitaxel as First-line Treatment for Metastatic Pancreatic Cance


Sponsor

Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

Enrollment

50 participants

Start Date

Apr 18, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This trial was a single-arm, open-label design to evaluate the efficacy and safety of "TQB2916+ gemcitabine + albumin-paclitaxel" as the first-line treatment for metastatic pancreatic cancer.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug combination as a first-line treatment for metastatic pancreatic cancer (cancer that has spread beyond the pancreas). The treatment includes a targeted drug called TQB2916, which is being combined with other agents. The goal is to see if this combination is effective and safe for patients who have not yet received any systemic treatment. **You may be eligible if...** - You are between 18 and 75 years old - You have been confirmed by biopsy to have pancreatic ductal adenocarcinoma (the most common type of pancreatic cancer) - Your cancer has measurable lesions on imaging - You have not received any prior cancer treatment for this disease - You are in good health (ECOG score 0–1) and your organs are functioning well **You may NOT be eligible if...** - You have had another cancer in the past 5 years (with some exceptions for early-stage cured cancers) - You have had major surgery within the past 28 days - You have had a serious bleeding event in the past 4 weeks - You had a stroke, blood clot, or pulmonary embolism in the past 6 months - You have active autoimmune disease or need ongoing immunosuppressive treatment - Your cancer has spread to the brain or spinal cord Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTQB2916 Injection

A Phase II clinical study to evaluate the efficacy and safety of TQB2916 injection combined with gemcitabine and albumin-paclitaxel as first-line treatment for metastatic pancreatic cancer.

DRUGChemotherapy

Chemotherapy is a systematic treatment.Chemotherapy drugs go into the body orally or intravenously, and they circulate throughout the body, and because of that, they can be used for advanced cancer, and they can also be effective against metastasized cancer cells.There are many chemotherapeutics, but the underlying mechanism is to kill fast growing cells.


Locations(1)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

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NCT06962267


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