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

Primary Purpose

Pancreatic Adenocarcinoma Metastatic

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Penpulimab
Anlotinib
Nab paclitaxel
Gemcitabine
Sponsored by
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Adenocarcinoma Metastatic focused on measuring advanced metastatic pancreatic cancer, Chemotherapy, immunotherapy, Targeted Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Ages ≥18 years,ECOG ≤ 2,Estimated survival time > 3 months Histologically or Cytologically confirmed metastatic pancreatic adenocarcinoma Based on Response Evaluation Criteria In Solid Tumors (RECIST1.1), there should be at least one measurable lesion Patients have never received systematical anti-cancer therapy Laboratory examination meets the following requirements: White blood cell (WBC) ≥3.0×109/L; absolute neutrophil count (ANC) ≥1.5×109/L; Hemoglobin (HB) ≥90g/L; platelet count(PLT) ≥75×109/L; Total bilirubin (TBIL) ≤1.5× normal upper limit (ULN); Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST)≤2.5×ULN, if accompanied by liver metastasis, ALT and AST≤5×ULN; Serum creatinine (Cr) ≤1×ULN or creatinine clearance (CCr)≥50ml/min; Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) > 50% Patients of childbearing age should take appropriate protective measures before enrollment and during the trial Volunteer to join the study, sign the informed consent, have good compliance, and cooperate with follow-up Ability to follow the study protocol and follow-up procedures. Exclusion Criteria: Patients have ever received any systematical anti-cancer therapy in the past Patients who participated in other clinical trials in the past 4 weeks According to the investigator, patients who surgically available or potentially treatable(Patients who voluntarily give up surgical treatment can be enrolled after evaluation by the investigator) Patients with moderate ascites requiring drainage Patients with CNS metastases and/or carcinomatous meningitis Patients with history of other primary malignancies except: 1) complete remission before enrollment for at least 2 years and requiring no additional treatment during the study period; 2) Adequately treated non-melanoma skin cancer or lentiform malignancy with no evidence of disease recurrence; 3) Adequately treated carcinoma in situ with no evidence of disease recurrence; Patients with autoimmune disease or immune deficiency who are treated with immunosuppressive drugs Patients with bleeding tendency. Pregnant or lactating women. Drug abuse, clinical or psychological or social factors that impact informed consent or the conduct of the study Patients who may be allergic to PD-1 monoclonal antibody, anlotinib, albumin-bound paclitaxel and gemcitabine

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Trial group

Control group

Arm Description

penpulimab in combination with anlotinib and AG regimen in the first-line treatment of advanced metastatic pancreatic cancer

AG regimen in the first-line treatment of advanced metastatic pancreatic cancer

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)
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
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.

Full Information

First Posted
September 18, 2023
Last Updated
September 18, 2023
Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT06051851
Brief Title
Penpulimab Combined With Anlotinib and Nab-paclitaxel Plus Gemcitabine as First-line Treatment for Advanced Metastatic Pancreatic Cancer
Acronym
RCT-PAAG
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Actual)
Primary Completion Date
July 1, 2025 (Anticipated)
Study Completion Date
July 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Adenocarcinoma Metastatic
Keywords
advanced metastatic pancreatic cancer, Chemotherapy, immunotherapy, Targeted Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
177 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Trial group
Arm Type
Experimental
Arm Description
penpulimab in combination with anlotinib and AG regimen in the first-line treatment of advanced metastatic pancreatic cancer
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
AG regimen in the first-line treatment of advanced metastatic pancreatic cancer
Intervention Type
Drug
Intervention Name(s)
Penpulimab
Intervention Description
Penpulimab 200mg IV D1 1 cycle every 21 days
Intervention Type
Drug
Intervention Name(s)
Anlotinib
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Nab paclitaxel
Intervention Description
Nab-paclitaxel 125mg/m2 I.V. D1,8 1 cycle every 21 days
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
Gemcitabine 1.0g/m2 I.V. D1,8 1 cycle every 21 days
Primary Outcome Measure Information:
Title
Progression-free survival(PFS)
Description
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.
Time Frame
up to 1 years
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
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)
Time Frame
up to 1 years
Title
Disease Control Rate (DCR)
Description
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
Time Frame
up to 1 years
Title
Overall Survival (OS)
Description
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.
Time Frame
up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Ages ≥18 years,ECOG ≤ 2,Estimated survival time > 3 months Histologically or Cytologically confirmed metastatic pancreatic adenocarcinoma Based on Response Evaluation Criteria In Solid Tumors (RECIST1.1), there should be at least one measurable lesion Patients have never received systematical anti-cancer therapy Laboratory examination meets the following requirements: White blood cell (WBC) ≥3.0×109/L; absolute neutrophil count (ANC) ≥1.5×109/L; Hemoglobin (HB) ≥90g/L; platelet count(PLT) ≥75×109/L; Total bilirubin (TBIL) ≤1.5× normal upper limit (ULN); Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST)≤2.5×ULN, if accompanied by liver metastasis, ALT and AST≤5×ULN; Serum creatinine (Cr) ≤1×ULN or creatinine clearance (CCr)≥50ml/min; Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) > 50% Patients of childbearing age should take appropriate protective measures before enrollment and during the trial Volunteer to join the study, sign the informed consent, have good compliance, and cooperate with follow-up Ability to follow the study protocol and follow-up procedures. Exclusion Criteria: Patients have ever received any systematical anti-cancer therapy in the past Patients who participated in other clinical trials in the past 4 weeks According to the investigator, patients who surgically available or potentially treatable(Patients who voluntarily give up surgical treatment can be enrolled after evaluation by the investigator) Patients with moderate ascites requiring drainage Patients with CNS metastases and/or carcinomatous meningitis Patients with history of other primary malignancies except: 1) complete remission before enrollment for at least 2 years and requiring no additional treatment during the study period; 2) Adequately treated non-melanoma skin cancer or lentiform malignancy with no evidence of disease recurrence; 3) Adequately treated carcinoma in situ with no evidence of disease recurrence; Patients with autoimmune disease or immune deficiency who are treated with immunosuppressive drugs Patients with bleeding tendency. Pregnant or lactating women. Drug abuse, clinical or psychological or social factors that impact informed consent or the conduct of the study Patients who may be allergic to PD-1 monoclonal antibody, anlotinib, albumin-bound paclitaxel and gemcitabine
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juan Du
Phone
+0086-13951826526
Email
dujuanglyy@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan Du
Organizational Affiliation
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Du, PhD
Phone
+0086-13951826526
Email
dujuanglyy@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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