RecruitingPhase 2NCT06051851

Penpulimab Combined With Anlotinib and Nab-paclitaxel Plus Gemcitabine as First-line Treatment for Advanced Metastatic Pancreatic Cancer

Penpulimab Combined With Anlotinib and Nab-paclitaxel Plus Gemcitabine (PAAG) as First-line Treatment for Advanced Metastatic Pancreatic Cancer: a Prospective, Multicenter, Single-arm, Phase 2 Study


Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Enrollment

177 participants

Start Date

Jul 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a multi-center, open-label, randomized controlled Phase II clinical study to observe and evaluate the efficacy and safety of Penpulimab combined with Anlotinib and Nab-paclitaxel plus Gemcitabine (PAAG ) versus AG first-line treatment in patients with metastatic pancreatic cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a four-drug combination as the first treatment for advanced metastatic pancreatic cancer: two chemotherapy drugs (nab-paclitaxel and gemcitabine), a targeted drug (anlotinib), and an immunotherapy drug (penpulimab). Researchers hope this combination will improve survival compared to standard two-drug chemotherapy. **You may be eligible if...** - You are 18 or older and have been diagnosed with metastatic pancreatic cancer confirmed by biopsy - You have at least one tumor that can be measured on a scan - You have never received systemic cancer treatment before - Your blood counts and organ function are within acceptable ranges - Your overall health is adequate and life expectancy is more than 3 months **You may NOT be eligible if...** - You have received prior systemic chemotherapy or other cancer treatments - You have significant heart, liver, kidney problems, or active infections - You are pregnant or breastfeeding 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

DRUGPenpulimab

Penpulimab 200mg IV D1 1 cycle every 21 days

DRUGAnlotinib

Anlotinib 12mg/10mg P.O. QD D1-14 (12mg for body surface area ≥1.6m2, 10mg for body surface area ≤1.6m2) 1 cycle every 21 days

DRUGNab paclitaxel

Nab-paclitaxel 125mg/m2 I.V. D1,8 1 cycle every 21 days

DRUGGemcitabine

Gemcitabine 1.0g/m2 I.V. D1,8 1 cycle every 21 days


Locations(1)

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

View Full Details on ClinicalTrials.gov

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NCT06051851


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