DC-CIK immune cell therapy combined with PD-1/CTLA-4 bispecific antibody and regorafenib for third-line advanced colorectal cancer
Efficacy and Safety Study of DC-CIK Cell Therapy Combined With Epaloliposide, Vortexil, and Regorafenib as Third-line Treatment for Advanced Colorectal Cancer.
This treatment tries to see if combining a patient's own DC-CIK immune cells with a PD-1/CTLA-4 bispecific antibody plus regorafenib helps people with advanced colorectal cancer who have already received standard therapies.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 14 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Jinling Hospital, China Academic / other |
| Drugs / interventions | Epaglitovirizumab, chemotherapy, immunotherapy |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT07343791 on ClinicalTrials.gov |
What this trial studies
This is a single-arm, open-label early-phase study testing a triple combination of autologous DC‑CIK cell immunotherapy, a domestic PD‑1/CTLA‑4 bispecific antibody (iparomlimab/tuvonralimab), and the multi‑kinase inhibitor regorafenib in patients with metastatic colorectal cancer after standard treatments. The protocol enrolls adults 18–75 years with ECOG 0–1 and expected survival >3 months, and excludes patients with active CNS metastases, uncontrolled hypertension, recent major bleeding, or uncontrolled effusions. Primary goals are to characterize safety and signals of clinical activity in the third-line setting and to explore immune biomarkers and mechanisms of response. Treatment requires leukapheresis for DC‑CIK manufacture and repeated clinic visits for drug dosing and monitoring.
Who should consider this trial
Good fit: Ideal candidates are adults (18–75) with metastatic colorectal cancer who have progressed after prior standard therapies, have ECOG performance status 0–1, and are medically fit for leukapheresis, immunotherapy, and regorafenib.
Not a fit: Patients with active central nervous system metastases, uncontrolled hypertension, recent life‑threatening bleeding, symptomatic effusions requiring drainage, or uncontrolled serious comorbidities are unlikely to benefit or be eligible for this protocol.
Why it matters
Potential benefit: If successful, the combination could increase response rates and extend disease control for patients with refractory metastatic colorectal cancer who have limited third-line options.
How similar studies have performed: Prior small studies and early-phase combinations of regorafenib with immune agents and separate DC‑CIK approaches have shown limited and mixed signals, but this specific triple combination is novel and not yet validated in larger trials.
Eligibility criteria
Show full inclusion / exclusion 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;
Where this trial is running
Nanjing, Jiangsu
- Jinling Hospital — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Zhang Yan
- Email: zhang2016zy@sina.com
- Phone: +86-13770663421
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.