To Determine the Efficacy and Safety of Envafolimab Combined With XELOX for Locally Advanced Colon Cancer

NCT05335460 | Unknown Phase 2

• 1 other identifier: STEP-EX001
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective is to investigate the efficacy and safety of Envafolimab combined with XELOX in neoadjuvant therapy for locally advanced colon cancer

Conditions

Colon Cancer

Keywords

locally advanced colon cance; Envafolimab

Outcome Measures

Primary Outcomes (1)

• TRG0/1

  the rate of Tumor Regression Grading level 0/1

  within 7 days after surgery

Secondary Outcomes (2)

• R0 resection rate

  within 7 days after surgery

• ORR

  within 1 year after surgery

Other Outcomes (1)

• PCR rate

  within 7 days after surgery

Study Arms (1)

Envafolimab combined with XELOX regimen

EXPERIMENTAL

Envafolimab:300mg,sc,d1,Q3W XELOX( Oxaliplatin 130mg/m2,ivgtt, Q3w capecitabine 1000mg/m2, p.o Q3w)

Drug: Envafolimab

Interventions

Envafolimab DRUG

300mg,sc,d1,Q3W

Also known as: XELOX( Oxaliplatin 130mg/m2,ivgtt, Q3w capecitabine 1000mg/m2, p.o Q3w)

Envafolimab combined with XELOX regimen

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological confirmation of colon adenocarcinoma
• Radiological signs, evaluated by CT, of T4 or Tany N+ (AJCC 8th) 3 No metastatic involvement in other organs (M0). 4 Uncomplicated primary tumor 5 Patients who have not received systemic chemotherapy or other anti-tumor treatment 6 18-75 years； 7 ECOG 0-1； 8 The patient must have adequate organ function and meet the following laboratory test values during the screening period within 7 days before enrolling:
• Absolute neutrophil cell count (ANC) ≥1.5x109/L, platelet ≥75x109/L, hemoglobin ≥90g/L.(in (Patients with no blood transfusion or growth factor support should be given for 7 days prior to blood collection.)
• Serum creatinine ≤1.5× upper normal range (ULN) or estimated creatinine clearance ≥50mL/min, Glutamate aminotransferase and glutamate aminotransferase (AST and ALT)≤3×ULN.
• Total bilirubin ≤1.5×ULN;If there is Gilbert syndrome or if the indirect bilirubin concentration indicates an extrahepatic source of bile The rise of erythrosin is ≤3×ULN.
• Aptt ≤1.5×ULN, and INR or PT≤1.5×ULN. 9 Systemic corticosteroids or other systemic immunosuppressive drugs were used within 2 weeks prior to treatment. Immunosuppressive drugs were started or expected to be used during the trial. Inhaled corticosteroids, physiologic replacement doses of glucocorticoids are allowed 10 Sign written informed consent. 11 Expected overall survival ≥3 months 12 A person is operation and compliance with medical treatment

You may not qualify if:

• Known to be allergic to any study drug
• The patient has a history of autoimmune disease
• Systemic corticosteroids or other systemic immunosuppressive drugs were used within 2 weeks prior to treatment.
• The patient has severe active infections
• A person is known to be infected with the immunodeficiency virus (HIV) or known to be HIV-positive 6、Patients Have high blood pressure that cannot be well controlled by antihypertensive medication or any other uncontrolled disease
• pregnant women or Lactating women 8 The patient has mental illness and cannot comply with the study regulations 9 According to the judgment of the researcher, the patient have other factors that may affect the results of the study or cause the study to be terminated, such as alcohol abuse, drug abuse, other serious diseases (including mental diseases) requiring combined treatment. Patients have severe laboratory abnormalities, which will affect the safety of the patient.

Sponsors & Collaborators

• Fujian Cancer Hospital: lead

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

envafolimab

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Central Study Contacts

Zaisheng Ye

CONTACT

13950203076; flyingengel@sina.com

Study Design

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

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: April 19, 2022
• Study Start: May 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2024
• Last Updated: April 19, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share