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

NCT05298020 | Unknown Phase 2

• 1 other identifier: XYFY2022-ENVA001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Pancreatic Cancer

Keywords

Advanced pancreatic cancer; Envafolimab; Endostar; AG regimen

Outcome Measures

Primary Outcomes (2)

• ORR

  Objective response rate

  6 months

• PFS

  Progressives free survival

  6 months

Secondary Outcomes (3)

• OS

  12 months

• DCR

  12 months

• AEs

  12 months

Study Arms (1)

Envafolimab and Endostar plus AG regimen

EXPERIMENTAL

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; Drug: Endostar; Drug: Nab paclitaxel; Drug: Gemcitabine

Interventions

Envafolimab DRUG

400mg,sc,d1,Q4W

Also known as: Immunotherapy

Envafolimab and Endostar plus AG regimen

Endostar DRUG

210mg，CIV72h，d1-3，Q4W

Also known as: endostatin

Envafolimab and Endostar plus AG regimen

Nab paclitaxel DRUG

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

Also known as: Chemotherapy

Envafolimab and Endostar plus AG regimen

Gemcitabine DRUG

1000mg/m2, iv,d1,d8，Q4W

Also known as: Chemotherapy

Envafolimab and Endostar plus AG regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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% ）；

You may not qualify if:

• 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;

Sponsors & Collaborators

• The Affiliated Hospital of Xuzhou Medical University: lead

Study Sites (1)

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221006, China

Location

MeSH Terms

Interventions

envafolimab; Immunotherapy; endostar protein; Endostatins; Taxes; Drug Therapy; Gemcitabine

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics; Angiostatic Proteins; Angiogenic Proteins; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Collagen Type XVIII; Non-Fibrillar Collagens; Collagen; Extracellular Matrix Proteins; Scleroproteins; Biological Factors; Economics; Health Care Economics and Organizations; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Zhengxiang Han, MD

CONTACT

18052268612; cnhzxyq@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2022
• First Posted: March 28, 2022
• Study Start: April 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: April 1, 2023
• Last Updated: March 28, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)