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Completed

NCT Number: NCT05493995

A Study of Penpulimab and Anlotinib Plus Nab-paclitaxel and Gemcitabine for Metastatic Pancreatic Cancer.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Penpulimab

Drug

Penpulimab 200 mg administered intravenously every 3 weeks.

Other names: AK105

Anlotinib

Drug

12mg, continuous oral 2 weeks stop for 1 week, 21 days for a treatment cycle.

Nab paclitaxel

Drug

125mg/m^2,administered intravenously on days 1 and 8 of every 21-day cycle.

Gemcitabine

Drug

1.0g/m^2, administered intravenously on days 1 and 8 of every 21-day cycle.

Primary outcomes

  1. 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).

  2. 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.

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: up to 3 years

    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.

  2. Progression-free survival (PFS)

    Time frame: up to 3 years

    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.

Sponsors and collaborators

Lead sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Other

Collaborators

  • Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Registry information

Official study 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.

Acronym: PAAG

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 9, 2022
Registry last updated
May 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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