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.
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.
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.
Sequential
Autologous immune Cells
Biological/Vaccine1. 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.
Standard chemotherapy
DrugInvestigator'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.
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.
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.
Progression-Free Survival (PFS)
The length of time during which a participant remains alive and their disease does not progress.
Overall Survival (OS)
The length of time from the start of treatment that participants are still alive.
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.
Duration of Response (DoR)
The length of time that a tumor continues to respond to treatment without the cancer growing or spreading.
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Liaoning Medical Diagnosis and Treatment Technology Research and Development Co., Ltd.
Lead sponsor
Liaoning Cancer Hospital & Institute
Collaborator
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