Colon CancerPhase 2NeoCHICNCT06368141
Neoadjuvant Chemotherapy Plus Sequential Immune Checkpoint Inhibitor (ICI) Therapy in Locally Advanced Colon Cancer
A Phase 2 study testing Serplulimab, Capecitabine and Oxaliplatin in people with Colon Cancer, run by Ruijin Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Serplulimab, Capecitabine and Oxaliplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to 30 Apr 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
- 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;
- Women of childbearing age must undergo a serum pregnancy test within 14 days before treatment, and the result is negative. And they are willing to use medically recognized effective contraceptive methods (such as intrauterine devices, contraceptives, or condoms) during the study period and within 3 months after the last dose of the study medication. For male subjects with partners of childbearing age, surgical sterilization is required, or it is recommended to use effective contraceptive methods during the study period and within 3 months after the last dose of the study medication.
Who cannot join
- 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);
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- 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.
- Patients who need to receive systemic corticosteroids (>10 mg/day prednisone efficacy dose) or other immunosuppressive drugs within the first 14 days of enrollment or during the study period.
- Any active infections that required systemic anti infective treatment, SARS-CoV-2 infection tested positive by RT-PCR within 14 days before the administration of the study drug. Subjects with a history of COVID-19 infection must have a negative RT-PCR test before the first administration of the study drug;
- History of major surgery within the first 28 days of randomization. The definition of major surgery in this study is that it requires at least 3 weeks of recovery time after surgery in order to receive surgery for treatment in this study.Patients who undergo tumor puncture or lymph node biopsy are eligible.
- Patient who has previously received treatment with other antibodies/drugs targeting immune checkpoints, such as PD-1, PD-L1, and cytotoxic T lymphocyte associated antigen 4 (CTLA-4).
- Patient who are currently participating in other clinical studies or planning to start treatment in this study less than 14 days from the end of the previous clinical study.
- Uncontrolled tumor related pain.
- History of severe allergies to any monoclonal antibody.
- History of allergies to any components of oxaliplatin and capecitabine.
- Women in pregnancy or lactating women.
- History of drug abuse of psychotropic substances or history of alcoholism.
- Any other disease with clinically significant metabolic abnormalities, physical examination abnormalities, or laboratory examination abnormalities, based on the judgment of the researcher, which is not suitable for the use of the study drug (such as having seizures and requiring treatment), or will affect the interpretation of the research results, or put the patient in a high-risk situation;
- Other factors that may cause the study to be terminated prematurely by the judgement of the researchers.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital
Shanghai, Shanghai Municipality, 200025
Tao Zhang, MD, +86-13918805942, woodyhom@yahoo.com
About this study
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
- Being tested
- Serplulimab, Capecitabine, Oxaliplatin
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SerplulimabDrug
Also called HLX10
Participants will receive a pre-operative CAPEOX and a sequential CAPEOX plus Serplulimab regimen.
CapecitabineDrug
Participants will receive a pre-operative CAPEOX and a sequential CAPEOX plus Serplulimab regimen.
OxaliplatinDrug
Participants will receive a pre-operative CAPEOX and a sequential CAPEOX plus Serplulimab regimen.
| Study group | Role | What they receive |
|---|---|---|
| NeoCHIC group | Experimental | Not described Receives: Drug: Serplulimab; Drug: Capecitabine; Drug: Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathologic complete response
pCR
Measured: 2 weeks after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start1 May 2024
- Primary completion28 Feb 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Ren, Ruijin Hospital
- Investigators
- Ren Zhao, PhD, Principal investigator, Ruijin Hosipital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06368141
- Sponsor's protocol ID
- 2023294
- Acronym
- NeoCHIC
- Status last verified
- Sep 2025
- First submitted
- 27 Nov 2023
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Chemotherapy Plus Sequential Immune Checkpoint Inhibitor (ICI) Therapy in Locally Advanced Colon Cancer
- ClinicalTrials.gov ID
- NCT06368141
- Acronym / sponsor ID
- NeoCHIC / 2023294
- Conditions
- Colon Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NeoCHIC group | Experimental | Drug: Serplulimab, Drug: Capecitabine, Drug: Oxaliplatin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (27 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SerplulimabAlso: HLX10Participants will receive a pre-operative CAPEOX and a sequential CAPEOX plus Serplulimab regimen. | Drug | NeoCHIC group |
| CapecitabineParticipants will receive a pre-operative CAPEOX and a sequential CAPEOX plus Serplulimab regimen. | Drug | NeoCHIC group |
| OxaliplatinParticipants will receive a pre-operative CAPEOX and a sequential CAPEOX plus Serplulimab regimen. | Drug | NeoCHIC group |
Primary outcome
pathologic complete response
Time frame: 2 weeks after operation
pCR
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ren Zhao, PhD principal investigator
Ruijin Hosipital, Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Serplulimab, Capecitabine and Oxaliplatin in people with Colon Cancer, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tao Zhang, PhD (+86 13918805942, woodyhom@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathologic complete response (time frame: 2 weeks after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.