NCT06051851

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 177 (estimated)
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study is a multi-center, open-label, randomized controlled Phase II clinical study to evaluate the efficacy and safety of penpulimab in combination with anlotinib and AG regimen in the first-line treatment of advanced metastatic pancreatic cancer, and to explore the clinical indicators related to efficacy to guide the individualized treatment. Trial group: Nab-paclitaxel 125mg/m2 I.V. D1,8 Gemcitabine 1.0g/m2 I.V. D1,8 Penpulimab 200mg IV D1 Anlotinib 12mg/10mg P.O. QD D1-14 (12mg for body surface area ≥1.6m2, 10mg for body surface area ≤1.6m2) Control group: Nab-paclitaxel 125mg/m2 I.V. D1,8 Gemcitabine 1.0g/m2 I.V. D1,8 1 cycle every 21 days Efficacy assessments will be performed every 2 cycles for the first 8 cycles of treatment. If treatment exceeds 8 cycles (24 weeks) in the trial group, maintenance therapy with anlotinib + PD1 and efficacy assessment every 2 cycles; in the control group, efficacy assessment every 2 cycles. Patient with disease control (CR+PR+SD) and tolerable adverse events were continued on the drug until discontinuation of the drug if efficacy was evaluated as disease progression (PD), if an intolerable adverse event occurred, or if the investigator deemed it unsuitable for the patient to continue on the treatment. Efficacy Indicators Primary endpoint: median progression-free survival (mPFS) Secondary endpoint: objective response rate (ORR), disease control rate (DCR), median overall survival (mOS), safety; potential biological indicators for predicting efficacy (tumor tissue NGS assay, ctDNA, mRNA, and various immune cytokines in peripheral blood, etc.) Safety evaluation indexes: Observe the presence or absence of clinical adverse events such as myelosuppression, nausea, vomiting, liver damage, skin reactions (e.g., rash), pneumonitis, hypertension, proteinuria, fatigue, and nausea, etc., which are graded according to NCI criteria.

Conditions

• Pancreatic Adenocarcinoma Metastatic

Interventions

Type	Name	Description
DRUG	Penpulimab	Penpulimab 200mg IV D1 1 cycle every 21 days
DRUG	Anlotinib	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
DRUG	Nab paclitaxel	Nab-paclitaxel 125mg/m2 I.V. D1,8 1 cycle every 21 days
DRUG	Gemcitabine	Gemcitabine 1.0g/m2 I.V. D1,8 1 cycle every 21 days

Timeline

• Start date: 2023-07-01
• Primary completion: 2025-07-01
• Completion: 2026-07-01
• First posted: 2023-09-25
• Last updated: 2023-09-25

Locations

1 site across 1 country: China