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

Envafolimab Combined With XELOX in Neoadjuvant Therapy for Locally Advanced Colon Cancer，A Prospective, Single Arm, Single Center ǁ Phase Clinical Trial

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

Study Overview

• Status: Not yet recruiting
• Conditions: Colon Cancer
• Intervention / Treatment: Drug: Envafolimab

Detailed Description

According to the 2019 NCCN guidelines, immunocheckpoint inhibitors are recommended for first-line treatment of metastatic colon cancer patients with high microsatellite instability (msi-h) or mismatched gene deletion (dMMR) who are not suitable for intensive treatment, and for all patients with second-line or above msi-h /dMMR treatment.

This study is a single-center, single-arm phase II study, patients received neoadjuvant therapy with Envafolimab combined with XELOX regimen, with one treatment cycle every 3 weeks and after two cycles accept surgery. To determine the pathologic downstage rates at time of radical resection of colon cancer following neoadjuvant treatment.

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Zaisheng Ye; Phone Number: 13950203076; Email: flyingengel@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Histological confirmation of colon adenocarcinoma

2. 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

Exclusion Criteria:

1. Known to be allergic to any study drug
2. The patient has a history of autoimmune disease
3. Systemic corticosteroids or other systemic immunosuppressive drugs were used within 2 weeks prior to treatment.
4. The patient has severe active infections
5. 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

7 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Envafolimab combined with XELOX regimen; Envafolimab:300mg,sc,d1,Q3W XELOX( Oxaliplatin 130mg/m2,ivgtt, Q3w capecitabine 1000mg/m2, p.o Q3w)	Drug: Envafolimab; 300mg,sc,d1,Q3W; Other Names: XELOX( Oxaliplatin 130mg/m2,ivgtt, Q3w capecitabine 1000mg/m2, p.o Q3w)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TRG0/1	the rate of Tumor Regression Grading level 0/1	within 7 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
R0 resection rate	The tumor was completely removed, and the cutting edge was negative under microscope, without tumor residue	within 7 days after surgery
ORR	Objective response rate	within 1 year after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
PCR rate	There were no residual tumor cells under microscope	within 7 days after surgery

Collaborators and Investigators

• Sponsor: Fujian Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2022
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): May 1, 2024

Study Registration Dates

• First Submitted: April 13, 2022
• First Submitted That Met QC Criteria: April 13, 2022
• First Posted (Actual): April 19, 2022

Study Record Updates

• Last Update Posted (Actual): April 19, 2022
• Last Update Submitted That Met QC Criteria: April 13, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Envafolimab; locally advanced colon cance
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Capecitabine; Oxaliplatin
• Other Study ID Numbers: STEP-EX001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No