DC-CIK TreatmentEarly Phase 1NCT07343791
Efficacy and Safety Study of DC-CIK Cell Therapy Combined With Epaloliposide, Vortexil, and Regorafenib as Third-line Treatment for Advanced Colorectal Cancer.
A Early Phase 1 study testing DC-CIK combined with regorafenib ,Iparomlimab and Tuvonralimab Injection in people with DC-CIK Treatment and Regorafenib, run by JIANG LONGWEI at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- DC-CIK Treatment, Regorafenib, Colorectal Cancer
- What is being tested?
- DC-CIK combined with regorafenib ,Iparomlimab and Tuvonralimab Injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteChina
- Study dates
- 19 Nov 2025to 30 Nov 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -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;
Who cannot join
- -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;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Jinling Hospital
Nanjing, Jiangsu, 210002
Zhang Yan, +86-13770663421, zhang2016zy@sina.com
Lei Zengjie
About this study
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.
Read more
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:
- Epaglitovirizumab: 5.0 mg/kg, intravenous injection, once every 21 days.
- Regorafenib: 120mg, once daily, orally, 1-21 days, repeated every 28 days.
- 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
- Being tested
- DC-CIK combined with regorafenib ,Iparomlimab and Tuvonralimab Injection
- Keywords
- DC-CIK treatment, Regorafenib, colorectal cancer, Immune combination therapy, Iparomlimab and Tuvonralimab Injection
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DC-CIK combined with regorafenib ,Iparomlimab and Tuvonralimab InjectionCombination product
Also called DC-CIK, regorafenib, Iparomlimab and Tuvonralimab Injection
- 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.
- 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.
- 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Combination Product: DC-CIK combined with regorafenib ,Iparomlimab and Tuvonralimab Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: From enrollment to the end of treatment (2 years)
Secondary outcomes (1)
Evaluate the safety and tolerability of the combination therapy.
Safety and tolerability were evaluated using Common Terminology Criteria for Adverse Events (CTCAE 5.0).
Measured: From enrollment to the end of the study (2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start19 Nov 2025
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DC-CIK TreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JIANG LONGWEI
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, JIANG LONGWEI, Jinling Hospital, China
- Investigators
- Lei Zengjie, Study chair, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07343791
- Sponsor's protocol ID
- zlk20251119
- Status last verified
- Jan 2026
- First submitted
- 18 Dec 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Study of DC-CIK Cell Therapy Combined With Epaloliposide, Vortexil, and Regorafenib as Third-line Treatment for Advanced Colorectal Cancer.
- ClinicalTrials.gov ID
- NCT07343791
- Acronym / sponsor ID
- zlk20251119
- Conditions
- DC-CIK Treatment, Regorafenib, Colorectal Cancer, Immune Combination Therapy, Iparomlimab and Tuvonralimab Injection
- Keywords
- DC-CIK treatment, Regorafenib, colorectal cancer, Immune combination therapy, Iparomlimab and Tuvonralimab Injection
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- JIANG LONGWEIUniversity, hospital or other
- Study start
- 19 Nov 2025 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Epaglitovirizumab: 5.0 mg/kg, intravenous injection, once every 21 days.
- Regorafenib: 120mg, once daily, orally, 1-21 days, repeated every 28 days.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DC-CIK cell immunity combined with Regorafenib,Iparomlimab and Tuvonralimab Injection | Experimental | Combination Product: DC-CIK combined with regorafenib ,Iparomlimab and Tuvonralimab Injection1. 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -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;
Key exclusion criteria (1 listed)
- -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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DC-CIK combined with regorafenib ,Iparomlimab and Tuvonralimab InjectionAlso: DC-CIK, regorafenib, Iparomlimab and Tuvonralimab Injection1. 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 | Combination product | DC-CIK cell immunity combined with Regorafenib,Iparomlimab and Tuvonralimab Injection |
Primary outcome
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.
Time frame: From enrollment to the end of treatment (2 years)
The efficacy effectiveness are evaluated by progression free survival (PFS)
objective clinical response using RESIST(version 1.1)
Time frame: From enrollment to the end of treatment (2 years)
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.
1 secondary outcome
Evaluate the safety and tolerability of the combination therapy.
Time frame: From enrollment to the end of the study (2 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lei Zengjie study chair
Jinling Hospital, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing DC-CIK combined with regorafenib ,Iparomlimab and Tuvonralimab Injection in people with DC-CIK Treatment and Regorafenib, run by JIANG LONGWEI at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhang Yan (+86-13770663421, zhang2016zy@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: From enrollment to the end of treatment (2 years)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.