DC-CIK immune cell therapy combined with PD-1/CTLA-4 bispecific antibody and regorafenib for third-line advanced colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Jinling Hospital
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Zhang Yan
• Email: zhang2016zy@sina.com
• Phone: +86-13770663421

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.