Lung Cancer (Locally Advanced or Metastatic)Phase 1/2NCT07260058
Immune Cell Therapy for Advanced Solid Tumors
A Phase 1/2 study testing Autologous immune Cells and Standard chemotherapy in people with Lung Cancer (Locally Advanced or Metastatic) and Liver Cancer (Locally Advanced or Metastatic), run by Liaoning Medical Diagnosis and Treatment Technology Research and Development Co., Ltd..
Trial summary
The autologous immune cell induction technology used in this project involves transforming peripheral blood mononuclear cells (PBMC) into autologous DC cells, NK cells, CIK cells and other immune cells through cytokine induction, and then re-administering them to the patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer (Locally Advanced or Metastatic), Liver Cancer (Locally Advanced or Metastatic), Colorectal Cancer (Locally Advanced or Metastatic)
- What is being tested?
- Autologous immune Cells and Standard chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 31 Dec 2027
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be eligible to participate in this study, an individual must meet all of the following criteria:
- The participant must voluntarily participate in the study and provide written informed consent。
- Age ≥ 18 years, male or female.
- Histologically and/or cytologically confirmed locally advanced or metastatic solid tumor: lung cancer, liver cancer, colorectal cancer, or breast cancer.
- ECOG (Eastern Cooperative Oncology Group) performance status score ≤ 2.
- Life expectancy ≥ 3 months.
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- Has not received any other cellular immunotherapy within 3 months prior to enrollment.
- Has at least one measurable lesion according to RECIST (Response Evaluation Criteria in Solid Tumors) Version 1.1.
- Adequate organ function, defined as follows:
- Hematology:
- White Blood Cell (WBC) count > 3.5 × 10⁹/L Lymphocyte count > 0.9 × 10⁹/L Monocyte count > 0.16 × 10⁹/L Absolute Neutrophil Count (ANC) > 1.5 × 10⁹/L Platelet (PLT) count > 75 × 10⁹/L Hemoglobin (HB) > 75 g/L Blood Biochemistry： Total bilirubin ≤ 1.5 × ULN (Upper Limit of Normal) Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN if liver metastases are present)
- Coagulation:
- Prothrombin Time (PT) and International Normalized Ratio (INR) ≤ 1.5 × ULN
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Prior receipt of any salvage chemotherapy, implanted intraperitoneal chemotherapy, targeted therapy, or biological immunotherapy (except: patients whose disease progressed more than 6 months after completing adjuvant, neoadjuvant, or radiosensitizing chemotherapy, or more than 1 month after intraperitoneal chemoperfusion/wash, are eligible, provided chemotherapy-related toxicities have recovered to Grade 1 or below, excluding alopecia).
- Major surgical procedure within 4 weeks prior to enrollment, with incomplete recovery from side effects.
- History of any active malignancy within 5 years, except for the specific cancer under investigation in this trial and cured localized tumors such as carcinoma in situ of the cervix, basal cell carcinoma of the skin, and prostate carcinoma in situ.
- Presence of more than a small amount of pericardial effusion, or uncontrolled pleural or peritoneal effusion, defined as: detectable by physical examination at screening, or requiring therapeutic paracentesis during the screening period.
- Inability to tolerate peripheral blood collection due to various reasons (e.g., severe coronary heart disease, inability to establish peripheral venous access).
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- Severe cardiovascular disease, including uncontrolled hypertension, unstable angina, history of myocardial infarction within the past 6 months, congestive heart failure > NYHA (New York Heart Association) Class III, or severe arrhythmia.
- Active infection, unexplained fever ≥ 38.5°C within 7 days prior to medication, or baseline white blood cell count > 15×10⁹/L; OR any severe acute or chronic infection requiring systemic antibacterial, antifungal, or antiviral therapy at screening (except for active hepatitis).
- Any active autoimmune disease or history of autoimmune diseases (e.g., but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; Patients with vitiligo; Patients with childhood asthma that has completely resolved in adulthood without any intervention are eligible; Asthma requiring bronchodilator medical intervention is excluded). Patients are eligible if: they have a history of autoimmune-related hypothyroidism and are on stable thyroid hormone replacement therapy; or have type I diabetes controlled by insulin therapy.
- History of drug allergy.
- Pregnant or lactating women; OR women of childbearing potential or men with pregnant partners who are unwilling to use adequate contraception during the planned trial period (from the screening visit until 120 days after the last study treatment).
- History of organ transplantation.
- Any other condition that, in the investigator's judgment, would make the participant unsuitable for the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Study on the Safety and Efficacy of Autologous Immune Cell Therapy for Advanced Solid Tumors
The autologous immune cell induction technology used in this project involves transforming peripheral blood mononuclear cells (PBMC) into autologous DC cells, NK cells, CIK cells and other immune cells through cytokine induction, and then re-administering them to the patients. This therapy utilizes biotechnology to culture the immune cells of cancer patients in vitro and then re-infuse them back into the body, stimulating and enhancing the body's own immune function, killing and inhibiting cancer cells, eliminating small and residual lesions, or achieving the goal of treating cancer by significantly inhibiting the proliferation of residual cancer cells.
Read the detailed description
This project focuses on the DC autologous immunocyte therapy based on the core technology of screening tumor antigen dominant CTL epitope peptides through independent patent technology. It is a cutting-edge research direction in the field of tumor immunotherapy in recent years. The non-engineered DC cells induced by special induction techniques can effectively overcome the shortcomings of the poor therapeutic effect of engineered gene editing technology on solid tumors, and effectively achieve targeted killing of tumors. The DC-CIK immunocyte therapy adopted in this project utilizes the original discovery of HLA-A molecule-restricted tumor-related antigen CTL epitope peptides to modify DC. On the one hand, through subcutaneous injection in vivo, it induces CD8+ T cells to produce CTL with memory function to play a role in eliminating and monitoring the protein with high expression of the tumor antigen source. On the other hand, it induces CD8+ T cells to produce CTL with memory function in vitro, and directly reinfuses CTL to exert the role of eliminating and monitoring the protein with high expression of the tumor antigen source. In the previous experimental studies, the CTL induced by G22 antigen-loaded DC has shown significant "identification" and targeted "killing" capabilities against various solid tumor cell lines and primary tumor cells isolated from tumor tissues. In animal experiments, it also shows the ability to induce the body to produce a strong immune response against various solid tumors such as breast cancer and non-small cell lung cancer, significantly inhibiting tumor growth, prolonging progression-free survival, and showing no obvious toxic side effects, having a promising application prospect. It has high individualization: customized based on the tumor mutation spectrum of patients, avoiding "off-target" damage to normal tissues. It has high safety: clinical studies have shown that the side effects are mild, mainly including injection site reactions or transient fever 37. Combined treatment potential: it can be used in combination with PD-1 inhibitors, chemotherapy or radiotherapy to enhance efficacy.
At present, self-active immune cell therapy based on tumor antigen-specific CTL epitope peptides has achieved significant progress in both research and clinical application in China. Personalized tumor vaccines, targeted immunoregulatory strategies for the tumor microenvironment, and combination treatment strategies are providing new concepts and methods for tumor therapy. In summary, the "Clinical Research on Safety and Effectiveness of Autologous Immune Cell Therapy for Advanced Solid Tumors" is expected to provide a clinical trial basis for the development of safe and effective clinical immunotherapies for patients with solid tumors.
- Conditions
- Lung Cancer (Locally Advanced or Metastatic), Liver Cancer (Locally Advanced or Metastatic), Colorectal Cancer (Locally Advanced or Metastatic), Breast Cancer (Locally Advanced or Metastatic), Advanced Solid Tumors
- Being tested
- Autologous immune Cells, Standard chemotherapy
- Keywords
- Advanced Solid Tumors, Metastatic Lung Cancer, Metastatic Liver Cancer, Metastatic Colorectal Cancer, Metastatic Breast Cancer, Autologous Immune Cell Therapy, Dendritic Cell Vaccine, CIK Cells, NK Cells
- Medical subject headings
- Lung Neoplasms, Neoplasm Metastasis, Liver Neoplasms, Colorectal Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous immune CellsBiological
- Autologous DC-CIK Cells：Dendritic Cells (DC) and Cytokine-Induced Killer (CIK) cells are manufactured ex vivo from the participant's own peripheral blood mononuclear cells (PBMCs). DC cells (>5x10⁶ cells) are administered via subcutaneous injection. CIK cells (>5x10⁹ cells) are administered via intravenous infusion.
- Autologous NK Cells：Natural Killer (NK) cells are manufactured ex vivo from the participant's own peripheral blood mononuclear cells (PBMCs). NK cells (≥3x10⁹ cells) are administered via intravenous infusion.
Standard chemotherapyDrug
Investigator's choice of standard chemotherapy regimen(s) appropriate for the participant's specific type of advanced solid tumor (lung, liver, colorectal, or breast cancer), administered according to local clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | This arm includes all participants who receive the investigational autologous immune cell therapy (either DC-CIK or NK cells), either alone or in combination with chemotherapy. It consolidates the following original arms:
Phase I - DC-CIK Therapy Arm Intervention Name: Autologous DC-CIK Cells
Phase I - NK Therapy Arm Intervention Name: Autologous NK Cells
Phase II - DC-CIK + Chemotherapy Arm Intervention Name: Autologous DC-CIK Cells+Standard Chemotherapy
Phase II - NK + Chemotherapy Arm Intervention Name:Autologous NK Cells+Standard Chemotherapy Receives: Biological: Autologous immune Cells; Drug: Standard chemotherapy |
| Control Group | Active comparator | This arm includes all participants who receive standard chemotherapy alone, without any investigational cell therapy. It consolidates the following original arms:
Phase II - Chemotherapy Control Arm (HLA-A Positive)
Phase II - Chemotherapy Control Arm (HLA-A Negative) Receives: Drug: Standard chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase II Primary Outcome: Objective Response Rate (ORR)
The proportion of participants who achieve a best overall response of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
Measured: From randomization until disease progression, assessed up to approximately 24 months
Phase I Primary Outcome: Incidence of Adverse Events (AEs)
The safety and tolerability of the autologous immune cell therapies (DC-CIK and NK) will be assessed by the incidence, type, and severity of adverse events. All AEs will be graded according to the NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0.
Measured: From cell infusion up to 3 months after the last infusion
Secondary outcomes (5)
Progression-Free Survival (PFS)
The length of time during which a participant remains alive and their disease does not progress.
Measured: From the start of treatment (Phase I) or randomization (Phase II) until disease progression or death from any cause, assessed up to approximately 24 months
Overall Survival (OS)
The length of time from the start of treatment that participants are still alive.
Measured: From the start of treatment (Phase I) or randomization (Phase II) until death from any cause, assessed up to approximately 36 months
Disease Control Rate (DCR)
The proportion of participants who achieve a best overall response of complete response (CR), partial response (PR), or stable disease (SD) according to RECIST 1.1.
Measured: From the start of treatment until the end of 4 treatment cycles, assessed up to 4 months
Duration of Response (DoR)
The length of time that a tumor continues to respond to treatment without the cancer growing or spreading.
Measured: From the first documented response (CR or PR) until disease progression or death, assessed up to approximately 24 months
Time to Recurrence (TTR)
The time from the start of treatment until the first documented recurrence of the cancer.
Measured: From the start of treatment until disease recurrence, assessed up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start1 Dec 2025 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer (Locally Advanced or Metastatic)Studies 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
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- This study employs a sequential, two-phase design that incorporates both non-randomized and randomized components: Phase I (Safety Lead-in): This initial phase is a non-randomized, biomarker-directed study. Participants are assigned to one of two autologous immune cell therapy regimens based on their HLA-A phenotype: HLA-A positive participants receive DC-CIK therapy. HLA-A negative participants receive NK cell therapy. The primary objective of this phase is to evaluate the safety and feasibility of the cell products. Phase II (Expansion): This subsequent phase is a randomized, parallel-group, controlled study. Following the HLA-A stratification: HLA-A positive participants are randomized to either the DC-CIK + Chemotherapy group or the Chemotherapy alone group. HLA-A negative participants are randomized to either the NK + Chemotherapy group or the Chemotherapy alone group. The primary objective of this phase is to evaluate the efficacy (Objective Response Rate) of the combinatio
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liaoning Medical Diagnosis and Treatment Technology Research and Development Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Liaoning Cancer Hospital & Institute
- Responsible party
- Sponsor
- Investigators
- Wei Minjie, Doctor, Study chair, Liaoning Medical Diagnosis and Treatment Technology Research and Development Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07260058
- Sponsor's protocol ID
- LNMDTC-Solid tumor
- Status last verified
- Sep 2025
- First submitted
- 28 Sep 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: What IPD? All of the individual participant data collected during the trial, after de-identification. When? Beginning 12 months after the primary publication and ending 36 months thereafter. With Whom? Researchers who provide a methodologically sound proposal. For What? To achieve aims in the approved proposal. Proposals should be directed to \[Corresponding Author Email\]. To gain access, data requestors will need to sign a data access agreement. Supporting Info? Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF)
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Safety and Efficacy of Autologous Immune Cell Therapy for Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07260058
- Acronym / sponsor ID
- LNMDTC-Solid tumor
- Conditions
- Lung Cancer (Locally Advanced or Metastatic), Liver Cancer (Locally Advanced or Metastatic), Colorectal Cancer (Locally Advanced or Metastatic), Breast Cancer (Locally Advanced or Metastatic), Advanced Solid Tumors
- Keywords
- Advanced Solid Tumors, Metastatic Lung Cancer, Metastatic Liver Cancer, Metastatic Colorectal Cancer, Metastatic Breast Cancer, Autologous Immune Cell Therapy, Dendritic Cell Vaccine, CIK Cells
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Liaoning Medical Diagnosis and Treatment Technology Research and Development Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Liaoning Cancer Hospital & Institute
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Dec 2025 (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.
The autologous immune cell induction technology used in this project involves transforming peripheral blood mononuclear cells (PBMC) into autologous DC cells, NK cells, CIK cells and other immune cells through cytokine induction, and then re-administering them to the patients. This therapy utilizes biotechnology to culture the immune cells of cancer patients in vitro and then re-infuse them back into the body, stimulating and enhancing the body's own immune function, killing and inhibiting cancer cells, eliminating small and residual lesions, or achieving the goal of treating cancer by significantly inhibiting the proliferation of residual cancer cells.
Detailed description
This project focuses on the DC autologous immunocyte therapy based on the core technology of screening tumor antigen dominant CTL epitope peptides through independent patent technology. It is a cutting-edge research direction in the field of tumor immunotherapy in recent years. The non-engineered DC cells induced by special induction techniques can effectively overcome the shortcomings of the poor therapeutic effect of engineered gene editing technology on solid tumors, and effectively achieve targeted killing of tumors. The DC-CIK immunocyte therapy adopted in this project utilizes the original discovery of HLA-A molecule-restricted tumor-related antigen CTL epitope peptides to modify DC. On the one hand, through subcutaneous injection in vivo, it induces CD8+ T cells to produce CTL with memory function to play a role in eliminating and monitoring the protein with high expression of the tumor antigen source. On the other hand, it induces CD8+ T cells to produce CTL with memory function in vitro, and directly reinfuses CTL to exert the role of eliminating and monitoring the protein with high expression of the tumor antigen source. In the previous experimental studies, the CTL induced by G22 antigen-loaded DC has shown significant "identification" and targeted "killing" capabilities against various solid tumor cell lines and primary tumor cells isolated from tumor tissues. In animal experiments, it also shows the ability to induce the body to produce a strong immune response against various solid tumors such as breast cancer and non-small cell lung cancer, significantly inhibiting tumor growth, prolonging progression-free survival, and showing no obvious toxic side effects, having a promising application prospect. It has high individualization: customized based on the tumor mutation spectrum of patients, avoiding "off-target" damage to normal tissues. It has high safety: clinical studies have shown that the side effects are mild, mainly including injection site reactions or transient fever 37. Combined treatment potential: it can be used in combination with PD-1 inhibitors, chemotherapy or radiotherapy to enhance efficacy.
At present, self-active immune cell therapy based on tumor antigen-specific CTL epitope peptides has achieved significant progress in both research and clinical application in China. Personalized tumor vaccines, targeted immunoregulatory strategies for the tumor microenvironment, and combination treatment strategies are providing new concepts and methods for tumor therapy. In summary, the "Clinical Research on Safety and Effectiveness of Autologous Immune Cell Therapy for Advanced Solid Tumors" is expected to provide a clinical trial basis for the development of safe and effective clinical immunotherapies for patients with solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study employs a sequential, two-phase design that incorporates both non-randomized and randomized components: Phase I (Safety Lead-in): This initial phase is a non-randomized, biomarker-directed study. Participants are assigned to one of two autologous immune cell therapy regimens based on their HLA-A phenotype: HLA-A positive participants receive DC-CIK therapy. HLA-A negative participants receive NK cell therapy. The primary objective of this phase is to evaluate the safety and feasibility of the cell products. Phase II (Expansion): This subsequent phase is a randomized, parallel-group, controlled study. Following the HLA-A stratification: HLA-A positive participants are randomized to either the DC-CIK + Chemotherapy group or the Chemotherapy alone group. HLA-A negative participants are randomized to either the NK + Chemotherapy group or the Chemotherapy alone group. The primary objective of this phase is to evaluate the efficacy (Objective Response Rate) of the combinatio
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Biological: Autologous immune Cells, Drug: Standard chemotherapyThis arm includes all participants who receive the investigational autologous immune cell therapy (either DC-CIK or NK cells), either alone or in combination with chemotherapy. It consolidates the following original arms: Phase I - DC-CIK Therapy Arm Intervention Name: Autologous DC-CIK Cells Phase I - NK Therapy Arm Intervention Name: Autologous NK Cells Phase II - DC-CIK + Chemotherapy Arm Intervention Name: Autologous DC-CIK Cells+Standard Chemotherapy Phase II - NK + Chemotherapy Arm Intervention Name:Autologous NK Cells+Standard Chemotherapy |
| Control Group | Active comparator | Drug: Standard chemotherapyThis arm includes all participants who receive standard chemotherapy alone, without any investigational cell therapy. It consolidates the following original arms: Phase II - Chemotherapy Control Arm (HLA-A Positive) Phase II - Chemotherapy Control Arm (HLA-A Negative) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- To be eligible to participate in this study, an individual must meet all of the following criteria:
- The participant must voluntarily participate in the study and provide written informed consent。
- Age ≥ 18 years, male or female.
- Histologically and/or cytologically confirmed locally advanced or metastatic solid tumor: lung cancer, liver cancer, colorectal cancer, or breast cancer.
- ECOG (Eastern Cooperative Oncology Group) performance status score ≤ 2.
Key exclusion criteria (13 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Prior receipt of any salvage chemotherapy, implanted intraperitoneal chemotherapy, targeted therapy, or biological immunotherapy (except: patients whose disease progressed more than 6 months after completing adjuvant, neoadjuvant, or radiosensitizing chemotherapy, or more than 1 month after intraperitoneal chemoperfusion/wash, are eligible, provided chemotherapy-related toxicities have recovered to Grade 1 or below, excluding alopecia).
- Major surgical procedure within 4 weeks prior to enrollment, with incomplete recovery from side effects.
- History of any active malignancy within 5 years, except for the specific cancer under investigation in this trial and cured localized tumors such as carcinoma in situ of the cervix, basal cell carcinoma of the skin, and prostate carcinoma in situ.
- Presence of more than a small amount of pericardial effusion, or uncontrolled pleural or peritoneal effusion, defined as: detectable by physical examination at screening, or requiring therapeutic paracentesis during the screening period.
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 |
|---|---|---|
| Autologous immune Cells1. Autologous DC-CIK Cells：Dendritic Cells (DC) and Cytokine-Induced Killer (CIK) cells are manufactured ex vivo from the participant's own peripheral blood mononuclear cells (PBMCs). DC cells (>5x10⁶ cells) are administered via subcutaneous injection. CIK cells (>5x10⁹ cells) are administered via intravenous infusion. 2. Autologous NK Cells：Natural Killer (NK) cells are manufactured ex vivo from the participant's own peripheral blood mononuclear cells (PBMCs). NK cells (≥3x10⁹ cells) are administered via intravenous infusion. | Biological | Experimental Group |
| Standard chemotherapyInvestigator's choice of standard chemotherapy regimen(s) appropriate for the participant's specific type of advanced solid tumor (lung, liver, colorectal, or breast cancer), administered according to local clinical practice. | Drug | Control Group, Experimental Group |
Primary outcome
Phase II Primary Outcome: Objective Response Rate (ORR)
Time frame: From randomization until disease progression, assessed up to approximately 24 months
The proportion of participants who achieve a best overall response of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
Phase I Primary Outcome: Incidence of Adverse Events (AEs)
Time frame: From cell infusion up to 3 months after the last infusion
The safety and tolerability of the autologous immune cell therapies (DC-CIK and NK) will be assessed by the incidence, type, and severity of adverse events. All AEs will be graded according to the NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0.
5 secondary outcomes
Progression-Free Survival (PFS)
Time frame: From the start of treatment (Phase I) or randomization (Phase II) until disease progression or death from any cause, assessed up to approximately 24 months
Overall Survival (OS)
Time frame: From the start of treatment (Phase I) or randomization (Phase II) until death from any cause, assessed up to approximately 36 months
Disease Control Rate (DCR)
Time frame: From the start of treatment until the end of 4 treatment cycles, assessed up to 4 months
Duration of Response (DoR)
Time frame: From the first documented response (CR or PR) until disease progression or death, assessed up to approximately 24 months
Time to Recurrence (TTR)
Time frame: From the start of treatment until disease recurrence, assessed up to approximately 24 months
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 2 Dec 2025.
- Individual participant dataSharing planned: Yes. What IPD? All of the individual participant data collected during the trial, after de-identification. When? Beginning 12 months after the primary publication and ending 36 months thereafter. With Whom? Researchers who provide a methodologically sound proposal. For What? To achieve aims in the approved proposal. Proposals should be directed to [Corresponding Author Email]. To gain access, data requestors will need to sign a data access agreement. Supporting Info? Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF)
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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.
Wei Minjie, Doctor study chair
Liaoning Medical Diagnosis and Treatment Technology Research and Development Co., Ltd.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Autologous immune Cells and Standard chemotherapy in people with Lung Cancer (Locally Advanced or Metastatic) and Liver Cancer (Locally Advanced or Metastatic), run by Liaoning Medical Diagnosis and Treatment Technology Research and Development Co., Ltd..
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 13 inclusion and 13 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: opening soon, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Chen Lin, Doctor (+86 024-88456888, jiaoxue@lnmdtc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase II Primary Outcome: Objective Response Rate (ORR) (time frame: From randomization until disease progression, assessed up to approximately 24 months). 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 2 Dec 2025.