Envafolimab Combined With Endostar And Chemotherapy For First-line Treatment Of Advanced Pancreatic Cancer

Study Overview

Envafolimab Combined With Endostar and Chemotherapy 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.

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.

Advanced Pancreatic Cancer

DRUG: Envafolimab
DRUG: Endostar
DRUG: Nab paclitaxel
DRUG: Gemcitabine

XYFY2022-ENVA001

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2022-03-18	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2022-03-18
First Submitted that Met QC Criteria 2022-03-18	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2022-03-28
First Posted (ACTUAL) 2022-03-28	Results First Posted N/A	Last Verified 2022-03

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Envafolimab and Endostar plus AG regimen Envafolimab: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).	DRUG: Envafolimab 400mg,sc,d1,Q4W DRUG: Endostar 210mg，CIV72h，d1-3，Q4W DRUG: Nab paclitaxel 125mg/m2,iv,d1,d8,Q4W DRUG: Gemcitabine 1000mg/m2, iv,d1,d8，Q4W

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Envafolimab and Endostar plus AG regimen

Envafolimab: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).

DRUG: Envafolimab

400mg,sc,d1,Q4W

DRUG: Endostar

210mg，CIV72h，d1-3，Q4W

DRUG: Nab paclitaxel

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

DRUG: Gemcitabine

1000mg/m2, iv,d1,d8，Q4W

Primary Outcome Measures	Measure Description	Time Frame
ORR	Objective response rate	6 months
PFS	Progressives free survival	6 months

Secondary Outcome Measures	Measure Description	Time Frame
OS	Overall survival	12 months
DCR	disease controll rate	12 months
AEs	Percentage of participants experiencing grade 3-5 adverse events	12 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Zhengxiang Han, MD

Phone Number: 18052268612

Email: cnhzxyq@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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% ）；

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;

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

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