A Study of Penpulimab and Anlotinib Plus Nab-paclitaxel and Gemcitabine for Metastatic Pancreatic Cancer.
PAAG
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.
1 other identifier
interventional
66
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 21, 2022
CompletedFirst Submitted
Initial submission to the registry
August 7, 2022
CompletedFirst Posted
Study publicly available on registry
August 9, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2024
CompletedMay 9, 2024
May 1, 2024
1.8 years
August 7, 2022
May 8, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
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 3 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 3 years
Secondary Outcomes (2)
Overall Survival (OS)
up to 3 years
Progression-free survival (PFS)
up to 3 years
Study Arms (1)
Penpulimab+Anlotinib+Nab-paclitaxel+Gemcitabine
EXPERIMENTALInterventions
Penpulimab 200 mg administered intravenously every 3 weeks.
12mg, continuous oral 2 weeks stop for 1 week, 21 days for a treatment cycle.
125mg/m\^2，administered intravenously on days 1 and 8 of every 21-day cycle.
1.0g/m\^2, administered intravenously on days 1 and 8 of every 21-day cycle.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008, China
Related Publications (1)
Sha H, Tong F, Ni J, Sun Y, Zhu Y, Qi L, Li X, Li W, Yang Y, Gu Q, Zhang X, Wang X, Zhu C, Chen D, Liu B, Du J. First-line penpulimab (an anti-PD1 antibody) and anlotinib (an angiogenesis inhibitor) with nab-paclitaxel/gemcitabine (PAAG) in metastatic pancreatic cancer: a prospective, multicentre, biomolecular exploratory, phase II trial. Signal Transduct Target Ther. 2024 Jun 7;9(1):143. doi: 10.1038/s41392-024-01857-6.
PMID: 38844468DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
August 7, 2022
First Posted
August 9, 2022
Study Start
July 21, 2022
Primary Completion
May 1, 2024
Study Completion
May 1, 2024
Last Updated
May 9, 2024
Record last verified: 2024-05