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Pancreatic NeoplasmsPhase 2PAAGNCT05493995

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

A Phase 2 study testing Penpulimab, Anlotinib and Nab paclitaxel in people with Pancreatic Neoplasms, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Neoplasms
What is being tested?
Penpulimab, Anlotinib and Nab paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteChina
Study dates
21 Jul 2022to 1 May 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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%
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  • 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.

Who cannot join

  • 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;
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  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

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

    Nanjing, Jiangsu, 210008

Other trials in China

About this study

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.

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.

Being tested
Penpulimab, Anlotinib, Nab paclitaxel, Gemcitabine
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PenpulimabDrug

    Also called AK105

    Penpulimab 200 mg administered intravenously every 3 weeks.

  • AnlotinibDrug

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

  • Nab paclitaxelDrug

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

  • GemcitabineDrug

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

Study groups in NCT05493995
Study groupRoleWhat they receive
Penpulimab+Anlotinib+Nab-paclitaxel+GemcitabineExperimentalNot described
Receives: Drug: Penpulimab; Drug: Anlotinib; Drug: Nab paclitaxel; Drug: Gemcitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: up to 3 years

  2. 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.

    Measured: up to 3 years

Secondary outcomes (2)

  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.

    Measured: up to 3 years

  2. 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.

    Measured: up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2022
  2. Study start21 Jul 2022
  3. Primary completion1 May 2024
  4. Study completion1 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05493995
Sponsor's protocol ID
2022-351-02
Acronym
PAAG
Status last verified
May 2024
First submitted
7 Aug 2022
Last updated
9 May 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 38844468

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Penpulimab, Anlotinib and Nab paclitaxel in people with Pancreatic Neoplasms, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: up to 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05493995, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.

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