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

NCT06368141 | Recruiting Phase 2 DMC

• 1 other identifier: 2023294
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Colon Cancer

Outcome Measures

Primary Outcomes (1)

• pathologic complete response

  pCR

  2 weeks after operation

Study Arms (1)

NeoCHIC group

EXPERIMENTAL

Drug: Serplulimab; Drug: Capecitabine; Drug: Oxaliplatin

Interventions

Serplulimab DRUG

Participants will receive a pre-operative CAPEOX and a sequential CAPEOX plus Serplulimab regimen.

Also known as: HLX10

NeoCHIC group

Capecitabine DRUG

Participants will receive a pre-operative CAPEOX and a sequential CAPEOX plus Serplulimab regimen.

NeoCHIC group

Oxaliplatin DRUG

Participants will receive a pre-operative CAPEOX and a sequential CAPEOX plus Serplulimab regimen.

NeoCHIC group

Eligibility Criteria

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

You may qualify if:

• 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 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).
• Sufficient organ and bone marrow function confirmed by laboratory examinations within 7 days prior to the first use of the study medication, without severe hematopoietic abnormalities, heart, lung, liver, kidney dysfunction, and immune deficiency \[no blood transfusion, albumin, recombinant human thrombopoietin, or colony stimulating factor (CSF) treatment was received within 14 days prior to the first use of the study medication\]:
• Absolute value of neutrophils ≥ 1.5 × 109/L, platelet ≥ 100 × 109/L, hemoglobin concentration ≥ 9g/dL);
• Liver function test: bilirubin ≤ 1.5 × ULN; aspartate transaminase and glutamate transaminase ≤ 2.5 × ULN; if there is liver metastasis, AST and ALT ≤ 5 × ULN;
• Renal function test: serum creatinine ≤ 1.5 × ULN, or creatinine clearance rate (CCr) ≥ 60ml/min;
• Coagulation: international standardized ratio (INR) ≤ 1.5 × ULN, prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN;
• Thyroid function: thyroid stimulating hormone (TSH) ≤ ULN; Should there be abnormalities, the levels of FT3 and FT4 should be examined. If the levels of FT3 and FT4 are normal, the patients can be included;

You may not qualify if:

• 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;
• III-IV cardiac insufficiency according to the New York Heart Association (NYHA) standard or left ventricular ejection fraction (LVEF)\<50% according to color Doppler ultrasound examination;
• Patients with active pulmonary tuberculosis.
• Patients with past and current conditions such as interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, and severely impaired lung function that may interfere with the detection and management of suspected drug-related pulmonary toxicity.
• The patient with known active or suspected autoimmune diseases. Patients with well controlled type I diabetes or immune related hypothyroidism who receive thyroid hormone replacement therapy are eligible. Patients with vitiligo who do not require intervention or with childhood asthma/allergies who have recovered without any intervention in adulthood are eligible.
• Patients who received live vaccine treatment within the first 28 days of enrollment.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Capecitabine; Oxaliplatin

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

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals

Study Officials

• Ren Zhao, PhD

  Ruijin Hosipital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tao Zhang, PhD

CONTACT

+86 13918805942; woodyhom@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: April 16, 2024
• Study Start: May 1, 2024
• Primary Completion: February 28, 2026
• Study Completion: April 30, 2026
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)