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Advanced Pancreatic CancerPhase 2NCT05298020

Envafolimab Combined With Endostar and Chemotherapy for First-line Treatment of Advanced Pancreatic Cancer

A Phase 2 study testing Envafolimab, Endostar and Nab paclitaxel in people with Advanced Pancreatic Cancer, run by The Affiliated Hospital of Xuzhou Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a single-arm, open-label, exploratory study to evaluate efficacy and safety of envafolimab combined with endostar and nab-paclitaxel plus gemcitabine for first-line treatment of advanced pancreatic cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Pancreatic Cancer
What is being tested?
Envafolimab, Endostar and Nab paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
1 Apr 2022to 1 Apr 2023
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

  • Pathologically proven pancreatic cancer ;
  • Age ≥ 18 years old, gender is not limited ; Expected survival ≥ 3 months ; ECOG 0-1; At least one measurable objective tumor lesion by spiral CT examination, the maximum diameter ≥ 1cm(according to RECIST 1.1); No previous chemotherapy, radiotherapy, immunotherapy, targeted therapy; The function of major organs is good, that is, the relevant inspection indicators within 14 days before enrollment meet the following requirements:(Hemoglobin ≥ 90 g/L (no blood transfusion within 14 days);Neutrophil count > 1.5×109/L; Platelet count ≥ 100×109/L;Total bilirubin ≤ 1.5×ULN (upper limit of normal);Blood alanine aminotransferase (ALT) or blood aspartate aminotransferase (AST) ≤2.5×ULN; if liver metastases, ALT or AST ≤ 5×ULN;Endogenous creatinine clearance ≥ 60 ml/min (Cockcroft-Gault formula);Cardiac Doppler Ultrasound Assessment: Left Ventricular Ejection Fraction (LVEF) ≥ 50% );

Who cannot join

  • Patients with other malignant tumors in the past or at the same time, and those tumors that are judged by the investigator to not affect the patient's life in the short term can be excluded; Participated in clinical trials of other drugs within four weeks ; Patients with known CNS metastases or a history of CNS metastases prior to screening. For patients with clinically suspected central nervous system metastasis, CT or MRI examination must be performed within 28 days before enrollment to exclude central nervous system metastasis; Patients with a history of unstable angina pectoris; newly diagnosed angina pectoris within 3 months before screening or myocardial infarction events within 6 months before screening; arrhythmia (including QTcF: male ≥ 450 ms, female ≥ 470 ms) requires Long-term use of antiarrhythmic drugs and New York Heart Association class ≥ II cardiac insufficiency; Urine routine indicates urine protein ≥++ and confirmed 24-hour urine protein quantification >1.0 g; For female subjects: should be surgically sterilized, postmenopausal, or agree to use a medically approved contraceptive during the study treatment period and within 6 months after the end of the study treatment period; Serum or urine pregnancy test must be negative within 7 days and must be non-nursing. Male subjects: should be surgically sterilized, or agree to use a medically approved contraceptive during the study treatment period and within 6 months after the end of the study treatment period; Have used immune targeted therapy drugs; Have a history of immunodeficiency, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation; Infectious pneumonia, non-infectious pneumonia, interstitial pneumonia and other patients who need corticosteroids; History of chronic autoimmune diseases, such as systemic lupus erythematosus; history of inflammatory bowel disease such as ulcerative colitis, Crohn's disease, history of chronic diarrheal diseases such as irritable bowel syndrome; history of sarcoidosis Medical history or history of tuberculosis; history of active hepatitis B, hepatitis C and HIV infection; Patients with allergic reactions to human or camel-derived monoclonal antibodies; Those who have a history of psychotropic substance abuse and cannot quit or have mental disorders; Pleural effusion or ascites with clinical symptoms requiring clinical intervention; According to the judgment of the investigator, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study;

Trial locations and contacts

1 site in 1 country.

Zhengxiang Han, MD contact

18052268612

cnhzxyq@163.com

China1 site
  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221006

Other trials in China

About this study

Official title: A Single-arm Phase II Study of Envafolimab Combined With Endostar and Nab-paclitaxel Plus Gemcitabine for First-line Treatment of Advanced Pancreatic Cancer

This is a single-arm, open-label, exploratory study to evaluate efficacy and safety of envafolimab combined with endostar and nab-paclitaxel plus gemcitabine for first-line treatment of advanced pancreatic cancer.

Read the detailed description

This study is a prospective, open-label, single-arm, exploratory clinical study.

Recruited 20 subjects who met the inclusion criteria and received Endostar+Envofolimab+Nab-paclitaxel/Gemcitabine (AG regimen) chemotherapy according to the study plan. Treatment duration and dose can be adjusted according to patient tolerance until disease progression or intolerable toxicity, or other conditions determined by the investigator. During the trial, the efficacy indicators and safety indicators were observed.

Being tested
Envafolimab, Endostar, Nab paclitaxel, Gemcitabine
Keywords
Advanced pancreatic cancer, Envafolimab, Endostar, AG regimen

What participants receive

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

  • EnvafolimabDrug

    Also called Immunotherapy

    400mg,sc,d1,Q4W

  • EndostarDrug

    Also called endostatin

    210mg,CIV72h,d1-3,Q4W

  • Nab paclitaxelDrug

    Also called Chemotherapy

    125mg/m2,iv,d1,d8,Q4W

  • GemcitabineDrug

    Also called Chemotherapy

    1000mg/m2, iv,d1,d8,Q4W

Study groups in NCT05298020
Study groupRoleWhat they receive
Envafolimab and Endostar plus AG regimenExperimentalEnvafolimab:400mg,sc,d1,Q4W; Endostar:210mg,CIV72h,d1-3,Q4W; Chemotherapy:AG (nab-paclitaxel:125mg/m2,iv,d1,d8,Q4W;gemcitabine:1000mg/m2, iv,d1,d8,Q4W).
Receives: Drug: Envafolimab; Drug: Endostar; Drug: Nab paclitaxel; Drug: Gemcitabine

What is being measured

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

  1. ORR

    Objective response rate

    Measured: 6 months

  2. PFS

    Progressives free survival

    Measured: 6 months

Secondary outcomes (3)
  1. OS

    Overall survival

    Measured: 12 months

  2. DCR

    disease controll rate

    Measured: 12 months

  3. AEs

    Percentage of participants experiencing grade 3-5 adverse events

    Measured: 12 months

Timeline

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

  1. First posted28 Mar 2022
  2. Study start1 Apr 2022 (estimated)
  3. Primary completion1 Dec 2022 (estimated)
  4. Study completion1 Apr 2023 (estimated)

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
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05298020
Sponsor's protocol ID
XYFY2022-ENVA001
Status last verified
Mar 2022
First submitted
18 Mar 2022
Last updated
28 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Envafolimab, Endostar and Nab paclitaxel in people with Advanced Pancreatic Cancer, run by The Affiliated Hospital of Xuzhou Medical University 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 28 Mar 2022. 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?

Results are not available in the source record.

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

Contact Zhengxiang Han, MD (18052268612, cnhzxyq@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: 6 months). 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?
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 28 Mar 2022.

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