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

Sponsor

The Affiliated Hospital of Xuzhou Medical University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05298020

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Pancreatic Cancer	Drug: Envafolimab Drug: Endostar Drug: Nab paclitaxel Drug: Gemcitabine	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Apr 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

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 Other Names: Immunotherapy Drug: Endostar 210mg，CIV72h，d1-3，Q4W Other Names: endostatin Drug: Nab paclitaxel 125mg/m2,iv,d1,d8,Q4W Other Names: Chemotherapy Drug: Gemcitabine 1000mg/m2, iv,d1,d8，Q4W Other Names: Chemotherapy

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

Other Names:

Immunotherapy

Drug: Endostar

210mg，CIV72h，d1-3，Q4W

Other Names:

endostatin

Drug: Nab paclitaxel

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

Other Names:

Chemotherapy

Drug: Gemcitabine

1000mg/m2, iv,d1,d8，Q4W

Other Names:

Chemotherapy

Outcome Measures

Primary Outcome Measures

ORR [6 months]
Objective response rate
PFS [6 months]
Progressives free survival

Secondary Outcome Measures

OS [12 months]
Overall survival
DCR [12 months]
disease controll rate
AEs [12 months]
Percentage of participants experiencing grade 3-5 adverse events

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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;