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2023-07-01
2025-07-01
2026-07-01
177
NCT06051851
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
INTERVENTIONAL
Penpulimab Combined With Anlotinib and Nab-paclitaxel Plus Gemcitabine as First-line Treatment for Advanced Metastatic Pancreatic Cancer
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2023-09-18 | N/A | 2023-09-18 |
2023-09-18 | N/A | 2023-09-25 |
2023-09-25 | N/A | 2023-07 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Trial group penpulimab in combination with anlotinib and AG regimen in the first-line treatment of advanced metastatic pancreatic cancer | DRUG: Penpulimab
DRUG: Anlotinib
DRUG: Nab paclitaxel
DRUG: Gemcitabine
|
| ACTIVE_COMPARATOR: Control group AG regimen in the first-line treatment of advanced metastatic pancreatic cancer | DRUG: Nab paclitaxel
DRUG: Gemcitabine
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Progression-free survival（PFS） | Progression-free Survival (PFS) (median) was determined using the number of months measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression) of participants. Progression is defined using RECIST v1.1, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | up to 1 years |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Objective response rate is defined as the percentage of subjects whose best response was complete response (CR) or partial response (PR) according to the Response Evaluation Criteria In Solid Tumors Criteria(RECIST v1.1) | up to 1 years |
| Disease Control Rate (DCR) | Disease control rate is defined as the percentage of subjects whose best response was CR, PR or stable disease (SD) according to the RECIST v1.1 | up to 1 years |
| Overall Survival (OS) | Overall Survival (OS) (median) is determined using the number of months measured from the initial date of treatment to the recorded date of death of participants. | up to 2 years |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Juan Du Phone Number: +0086-13951826526 Email: dujuanglyy@163.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
1
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
