NCT07343791 Efficacy and Safety Study of DC-CIK Cell Therapy Combined With Epaloliposide, Vortexil, and Regorafenib as Third-line Treatment for Advanced Colorectal Cancer.
| NCT ID | NCT07343791 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | JIANG LONGWEI |
| Condition | DC-CIK Treatment |
| Study Type | INTERVENTIONAL |
| Enrollment | 14 participants |
| Start Date | 2025-11-19 |
| Primary Completion | 2027-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 14 participants in total. It began in 2025-11-19 with a primary completion date of 2027-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Research background and purpose: Patients with advanced colorectal cancer face the dilemma of limited treatment options and poor efficacy in the third line treatment stage. Although regorafenib and immune checkpoint inhibitors bring hope to some patients, the efficacy still faces bottlenecks for the vast majority of microsatellite stable patients who are insensitive to immune monotherapy. This study is based on the multi mechanism synergistic theory of "immune activation+vascular inhibition+targeted killing". It innovatively combines autologous DC-CIK cell immunotherapy, domestic PD-1/CTLA-4 bispecific antibody (aparolitovorelli monoclonal antibody), and multi-target tyrosine kinase inhibitor (regorafenib) to evaluate the efficacy and safety of this triple therapy as a third line treatment for advanced colorectal cancer, and explore its immunological mechanism. Research content and methods: This study is a single arm, open label clinical trial. Plan to enroll advanced colorectal cancer patients who have previously failed second-line standard treatment. All participants will receive the following combination therapy regimen: 1. Epaglitovirizumab: 5.0 mg/kg, intravenous injection, once every 21 days. 2. Regorafenib: 120mg, once daily, orally, 1-21 days, repeated every 28 days. 3. DC-CIK cell therapy: Collect, culture, and transfuse cells during specific cycles. The study will strictly follow the protocol for efficacy evaluation (based on RECIST 1.1 standards) and safety monitoring, and a strict quality control and risk management system will be established. Main evaluation indicators and expected outcomes: * Primary endpoint: Objective response rate and safety. * Secondary endpoints: progression free survival, overall survival, duration of remission, and treatment-related immunological responses. * Expected outcome: This study is expected to provide a promising new comprehensive treatment strategy for chemotherapy resistant advanced colorectal cancer, especially MSS type patients, and break through existing efficacy bottlenecks. The research findings will provide high-level evidence-based medicine for the clinical application of this combined approach and lay the foundation for understanding its synergistic mechanism.
Eligibility Criteria
Inclusion Criteria: -1. Sign written informed consent before implementing any experimental procedures; 2. Male or female ≥ 18 years old, ≤ 75 years old; 3. ECOG PS score is 0-1 points; 4. Patients with metastatic colorectal cancer confirmed by histology or cytology; 5. Expected survival time\>3 months; Exclusion Criteria: -1. It is known that there is active CNS metastasis and/or cancerous meningitis; 2. Chest fluid, ascites, and pericardial effusion that require drainage due to clinical symptoms; 3. Any life-threatening bleeding events that have occurred within the past 3 months, including the need for blood transfusion therapy, surgery or local treatment, and continuous medication therapy; 4. Uncontrollable hypertension, with systolic blood pressure\>150mmHg or diastolic blood pressure\>90 mmHg after optimal medical treatment, history of hypertensive crisis or hypertensive encephalopathy; 5. Human immunodeficiency virus (HIV) infected individuals (HIV 1/2 antibody positive), known syphilis infected individuals;
Contact & Investigator
Lei Zengjie
STUDY CHAIR
Jinling Hospital, China
Frequently Asked Questions
Who can join the NCT07343791 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying DC-CIK Treatment. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07343791 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07343791 currently recruiting?
Yes, NCT07343791 is actively recruiting participants. Contact the research team at zhang2016zy@sina.com for enrollment information.
Where is the NCT07343791 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT07343791 clinical trial?
NCT07343791 is sponsored by JIANG LONGWEI. The principal investigator is Lei Zengjie at Jinling Hospital, China. The trial plans to enroll 14 participants.