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

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.

Conditions

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

Interventions

COMBINATION_PRODUCT

DC-CIK combined with regorafenib ,Iparomlimab and Tuvonralimab Injection

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

Sponsors & Collaborators

• JIANG LONGWEI

  lead OTHER

Principal Investigators

• Lei Zengjie · Jinling Hospital, China

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-11-19

Primary Completion

2027-11-30

Completion

2027-11-30

Countries

• China

Study Locations