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

NCT06051851 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 177

Last updated 2023-09-25

No results posted yet for this study

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.

Conditions

  • Pancreatic Adenocarcinoma Metastatic

Interventions

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

Sponsors & Collaborators

  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    lead OTHER

Principal Investigators

  • Juan Du · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-01
Primary Completion
2025-07-01
Completion
2026-07-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06051851 on ClinicalTrials.gov