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.

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School1 site in 1 country66 target enrollmentJuly 21, 2022

ConditionsPancreatic Neoplasms

InterventionsAnlotinib Penpulimab Nab paclitaxel Gemcitabine

DrugsPenpulimab Anlotinib Nab paclitaxel Gemcitabine

Overview

Phase: Phase 2
Intervention: Anlotinib
Conditions: Pancreatic Neoplasms
Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Enrollment: 66
Locations: 1
Primary Endpoint: Objective Response Rate (ORR)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 21, 2022

End Date

May 1, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Responsible Party

Principal Investigator

Du Juan

Clinical Professor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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

Arms & Interventions

Penpulimab+Anlotinib+Nab-paclitaxel+Gemcitabine

Intervention: Anlotinib

Penpulimab+Anlotinib+Nab-paclitaxel+Gemcitabine

Intervention: Penpulimab

Penpulimab+Anlotinib+Nab-paclitaxel+Gemcitabine

Intervention: Nab paclitaxel

Penpulimab+Anlotinib+Nab-paclitaxel+Gemcitabine

Intervention: Gemcitabine

Outcomes

Primary Outcomes

Objective Response Rate (ORR)

Time Frame: up to 3 years

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)

Time Frame: up to 3 years

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.