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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05298020
Other study ID # XYFY2022-ENVA001
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date April 1, 2022
Est. completion date April 1, 2023

Study information

Verified date March 2022
Source The Affiliated Hospital of Xuzhou Medical University
Contact Zhengxiang Han, MD
Phone 18052268612
Email cnhzxyq@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date April 1, 2023
Est. primary completion date December 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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% ); Exclusion Criteria: - 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;

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Envafolimab
400mg,sc,d1,Q4W
Endostar
210mg,CIV72h,d1-3,Q4W
Nab paclitaxel
125mg/m2,iv,d1,d8,Q4W
Gemcitabine
1000mg/m2, iv,d1,d8,Q4W

Locations

Country Name City State
China The Affiliated Hospital of Xuzhou Medical University Xuzhou Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
The Affiliated Hospital of Xuzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary ORR Objective response rate 6 months
Primary PFS Progressives free survival 6 months
Secondary OS Overall survival 12 months
Secondary DCR disease controll rate 12 months
Secondary AEs Percentage of participants experiencing grade 3-5 adverse events 12 months
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