Efficacy and Safety Study of DC-CIK Cell Therapy Combined With Epaloliposide, Vortexil, and Regorafenib as Third-line Treatment for Advanced Colorectal Cancer.

NCT07343791 | Recruiting Early Phase 1

• 1 other identifier: zlk20251119
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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:

• 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.

Conditions

Colorectal Cancer; Immune Combination Therapy; Iparomlimab and Tuvonralimab Injection; DC-CIK Treatment; Regorafenib

Keywords

DC-CIK treatment; Regorafenib; colorectal cancer; Immune combination therapy; Iparomlimab and Tuvonralimab Injection

Outcome Measures

Primary Outcomes (2)

• progression free survival (PFS)- Evaluate the effectiveness of DC-CIK cell therapy combined with aparolitovorelizumab and regorafenib regimen as a third line therapy in patients with advanced colorectal cancer.

  The efficacy effectiveness are evaluated by progression free survival (PFS)

  From enrollment to the end of treatment (2 years)

• objective clinical response using RESIST(version 1.1)

  Evaluate the effectiveness of DC-CIK cell therapy combined with aparolitovorelizumab and regorafenib regimen as a third line therapy in patients with advanced colorectal cancer.

  From enrollment to the end of treatment (2 years)

Secondary Outcomes (1)

• Evaluate the safety and tolerability of the combination therapy.

  From enrollment to the end of the study (2 years)

Study Arms (1)

DC-CIK cell immunity combined with Regorafenib,Iparomlimab and Tuvonralimab Injection

EXPERIMENTAL

1. Epaglitovirizumab: intravenous injection, 5.0 mg/kg, administered on the first day of each 21 day cycle. Continue treatment until disease progression, intolerable toxicity, withdrawal of informed consent, initiation of new anti-tumor therapy, or up to 2 years of use. 2. Regorafenib: Oral administration, 120mg (3 tablets 40mg), once daily, taken from day 1 to day 21 of a 28 day cycle. Dose adjustment should be made based on patient tolerance, and the minimum dose should not be less than 80mg per day. 3. DC-CIK cell therapy: * Collection and culture: Collect peripheral blood mononuclear cells from patients one day before treatment for in vitro induction and expansion of DC and CIK cells. * Return input: * DC feedback: 4 times in total. Starting from the 7th day after blood collection, subcutaneous injections were administered in the bilateral inguinal, axillary, and cervical lymph node areas, with a cell count of (1-5) × 10 \^ 7 cells per injection, twice a week. * CIK feedback: 3 times i

Combination Product: DC-CIK combined with regorafenib ,Iparomlimab and Tuvonralimab Injection

Interventions

DC-CIK combined with regorafenib ,Iparomlimab and Tuvonralimab Injection COMBINATION_PRODUCT

1. Epaglitovirizumab: intravenous injection, 5.0 mg/kg, administered on the first day of each 21 day cycle. Continue treatment until disease progression, intolerable toxicity, withdrawal of informed consent, initiation of new anti-tumor therapy, or up to 2 years of use. 2. Regorafenib: Oral administration, 120mg (3 tablets 40mg), once daily, taken from day 1 to day 21 of a 28 day cycle. Dose adjustment should be made based on patient tolerance, and the minimum dose should not be less than 80mg per day. 3. DC-CIK cell therapy：DC feedback: 4 times in total. Starting from the 7th day after blood collection, subcutaneous injections were administered in the bilateral inguinal, axillary, and cervical lymph node areas, with a cell count of (1-5) × 10 \^ 7 cells per injection, twice a week. * CIK feedback: 3 times in total. On the 7th day after blood collection (which may vary by 1-2 days depending on cell growth), intravenous infusion was performed with a cell volu A total of 4 treatment cycles

Also known as: DC-CIK, regorafenib, Iparomlimab and Tuvonralimab Injection

DC-CIK cell immunity combined with Regorafenib,Iparomlimab and Tuvonralimab Injection

Eligibility Criteria

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

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• JIANG LONGWEI: lead

Study Sites (1)

Jinling Hospital

Nanjing, Jiangsu, 210002, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

regorafenib

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Lei Zengjie

  Jinling Hospital, China

  STUDY CHAIR

Central Study Contacts

Zhang Yan

CONTACT

+86-13770663421; zhang2016zy@sina.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Researcher

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 15, 2026
• Study Start: November 19, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)