Neoadjuvant Chemotherapy Plus Sequential Immune Checkpoint Inhibitor (ICI) Therapy in Locally Advanced Colon Cancer

Ruijin Hospital1 site in 1 country56 target enrollmentMay 1, 2024

ConditionsColon Cancer

InterventionsSerplulimab Capecitabine Oxaliplatin

DrugsSerplulimab Capecitabine Oxaliplatin

Overview

Phase: Phase 2
Intervention: Serplulimab
Conditions: Colon Cancer
Sponsor: Ruijin Hospital
Enrollment: 56
Locations: 1
Primary Endpoint: pathologic complete response
Status: Recruiting
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The goal of this clinical trial is to learn the effect of neoadjuvant chemotherapy plus sequential immune checkpoint inhibitor (ICI) therapy in locally advanced colon cancer. The main questions it aims to answer are:

Does this neoadjuvant chemotherapy increase the pathologic complete response (pCR) of locally advanced colon cancer?
Does this neoadjuvant chemotherapy improve the long-term survival of locally advanced colon cancer?

Participants will receive:

a pre-operative CAPEOX (capecitabine oral + oxaliplatin i.v.)regimen.
a sequential CAPEOX plus Serplulimab regimen.
a standard complete mesocolic excision (CME) operation.

Registry

clinicaltrials.gov

Start Date

May 1, 2024

End Date

April 30, 2026

Last Updated

7 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Ruijin Hospital

Responsible Party

Principal Investigator

Zhao Ren

PhD

Ruijin Hospital

Eligibility Criteria

Inclusion Criteria

•Patients who volunteer to participate in this clinical trial and fully understand this study and sign the informed consent form (ICF), and willing to follow and capable of completing all testing procedures.
•Male or female aged 18-75 at the time of signing the ICF.
•Patients with histopathological confirmed primary colon adenocarcinoma
•MSS/RAS mutation patients with clinical stages T3N1-2 and T4N0-2
•an ECOG score of 0 or 1
•At least 1 measurable lesion according to RECIST 1.1 requirements.
•Patients must provide tumor tissue that meets the requirements for MSI/MMR testing.
•Expected survival period of at least 3 months.
•Negative hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (HBcAb) (-). If HBsAg (+) or HBcAb (+), hepatitis B virus deoxyribonucleic acid (HBV-DNA) must be \<2500 copies/mL or 500 IU/mL before inclusion.
•Negative HCV antibody or HCV-RNA. If HCV-RNA is positive, the patient must have alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN to be included. Patients with co-infection of hepatitis B and hepatitis C should be excluded (HBsAg or HBcAb test is positive, and HCV antibody test is positive).

Exclusion Criteria

•Patients with recurrent colon cancer, or primary colon cancer who has received the following treatments before: radiation therapy for tumors, surgery, chemotherapy, immunotherapy or molecular targeted therapy, and other clinical research drugs
•Severe infection (such as conditions which require intravenous infusion of antibiotics, antifungal drugs, or antiviral drugs) within 4 weeks prior to treatment, or unexplained fever \>38.5 ℃ during screening/initial administration;
•Hypertension without effective control through proper antihypertensive medication treatment (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg);
•Obvious clinical bleeding symptoms or obvious bleeding tendencies (bleeding\>30 mL within 3 months, vomiting blood, black stool, bloody stool), hemoptysis (fresh blood\>5 mL within 4 weeks), etc. within the first 3 months of treatment. Or patients with conditions that require long-term anticoagulant therapy with warfarin or heparin or long-term antiplatelet therapy (aspirin ≥ 300 mg/day or clopidogrel ≥ 75 mg/day), such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep venous thrombosis, and pulmonary embolism.
•Active heart disease, including myocardial infarction and severe/unstable angina, occurred 6 months before treatment. Left ventricular ejection fraction\<50% detected by echocardiography, with poor control of arrhythmia;
•Other malignant tumors within the past 5 years or at the same time (excluding cured skin basal cell carcinoma and cervical carcinoma in situ);
•Active or uncontrollable serious infections;
•Known human immunodeficiency virus (HIV) infection;
•Known clinically significant history of liver disease, including viral hepatitis \[known carriers of hepatitis B virus (HBV) must exclude active HBV infection, i.e. HBV DNA positivity (\>1 × 104 copies/mL or\>2000 IU/ml);
•Known hepatitis C virus infection (HCV) and HCV RNA positivity (\>1 × 103 copies/mL), or other hepatitis or cirrhosis;