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

Advanced Pancreatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05298020
• Other study ID #: XYFY2022-ENVA001
• Status: Not yet recruiting
• Phase: Phase 2
• 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
• 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;

Related Conditions & MeSH terms

• Advanced Pancreatic Cancer
• Pancreatic Neoplasms

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