Back to resultsA Study of Penpulimab and Anlotinib Plus Nab-paclitaxel and Gemcitabine for Metastatic Pancreatic Cancer. (PAAG)
Primary Purpose
Pancreatic Neoplasms
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Penpulimab
Anlotinib
Nab paclitaxel
Gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Neoplasms
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
Sites / Locations
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Penpulimab+Anlotinib+Nab-paclitaxel+Gemcitabine
Arm Description
Outcomes
Primary 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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT05493995
First Posted
August 7, 2022
Last Updated
November 23, 2022
Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborators
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05493995
Brief Title
A Study of Penpulimab and Anlotinib Plus Nab-paclitaxel and Gemcitabine for Metastatic Pancreatic Cancer.
Acronym
PAAG
Official Title
A Multicenter Study of Penpulimab and Anlotinib in Combination With Nab-paclitaxel Plus Gemcitabine as First-line Therapy in Patients (Pts) With Metastatic Pancreatic Cancer: PAAG.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborators
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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
It is a trial to assess the efficacy and safety of Penpulimab and Anlotinib in Combination With Nab-paclitaxel Plus Gemcitabine as first-line Therapy in Patients (Pts) With Metastatic Pancreatic Cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
66 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Penpulimab+Anlotinib+Nab-paclitaxel+Gemcitabine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Penpulimab
Other Intervention Name(s)
AK105
Intervention Description
Penpulimab 200 mg administered intravenously every 3 weeks.
Intervention Type
Drug
Intervention Name(s)
Anlotinib
Intervention Description
12mg, continuous oral 2 weeks stop for 1 week, 21 days for a treatment cycle.
Intervention Type
Drug
Intervention Name(s)
Nab paclitaxel
Intervention Description
125mg/m^2，administered intravenously on days 1 and 8 of every 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
1.0g/m^2, administered intravenously on days 1 and 8 of every 21-day cycle.
Primary 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 3 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 3 years
Secondary Outcome Measure Information:
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 3 years
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 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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, M.D. Ph.D
Phone
+86-025-83106666
Email
dujunglyy@163.com
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, M.D. Ph.D
Phone
+86-025-83106666
Email
dujunglyy@163.com
First Name & Middle Initial & Last Name & Degree
Juan Du, M.D. Ph.D
12. IPD Sharing Statement
Learn more about this trial
A Study of Penpulimab and Anlotinib Plus Nab-paclitaxel and Gemcitabine for Metastatic Pancreatic Cancer.
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