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Prospective, randomized, open, dual-arm, single-center clinical study of GI-DC/T cell immunotherapy for non-small cell lung cancer, breast cancer, and hepatocellular carcinoma

Prospective, randomized, open, dual-arm, single-center clinical study of GI-DC/T cell immunotherapy for non-small cell lung cancer, breast cancer, and hepatocellular carcinoma

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052023
Enrollment
Unknown
Registered
2021-10-14
Start date
2021-12-01
Completion date
Unknown
Last updated
2022-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small cell lung cancer, breast cancer, hepatocellular carcinoma

Interventions

Therapy group:Subcutaneous injection and infusion of autoimmune cells (GI-DC/T) combined with chemotherapy or intervention
Control group:Standard standard chemotherapy or standard traditional treatment

Sponsors

Foshan Traditional Chinese Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Non-small cell lung cancer group: 1. Aged 18-70 years, regardless of gender; 2. Primary non-small cell lung cancer diagnosed in accordance with the Guidelines for the Diagnosis and Treatment of Non-small Cell Lung Cancer 2020 designated by the Guidelines Working Committee of the Chinese Society of Clinical Oncology (CSCO); 3. Patients with intermediate/late stage primary non-small cell lung cancer; 4. There is at least one measurable (CT) lesion (1-5 cm); 5. Survival expected >= 3 months; follow-up compliance is good; 6. Sign the informed consent form voluntarily. Breast cancer group: 1. Aged 18-70 years, regardless of gender; 2. Patients with primary breast cancer who are diagnosed according to the Breast Cancer Diagnosis and Treatment Guidelines 2020 designated by the Guidelines Working Committee of the Chinese Society of Clinical Oncology (CSCO) or confirmed by histopathology/cytology; 3. Patients with intermediate/advanced breast cancer, no extensive remote metastasis or postoperative recurrence of breast cancer; 4. There is at least one measurable (MRI/ultrasound/CT) focus (1-5 cm); 5. Survival expected >= 3 months; follow-up compliance is good; 6. Sign the informed consent form voluntarily. Hepatocellular carcinoma group: 1. Aged 18-70 years, regardless of gender; 2. Patients with primary hepatocellular carcinoma (HCC) determined by pathological examinations or the Chinese National Health Commission's primary liver cancer diagnosis and treatment guidelines (2017 edition); 3. After intervention or hepatic artery chemoembolization (TACE) treatment, Child-Pugh class is graded A and B. Hepatocellular carcinoma patients without extensive distant metastasis (intermediate/late stage), at least one (CT/MRI) Measurable lesions (1-5 cm); 4. The postoperative period should be >= 2 weeks, and the expected survival period is >= 3 months; 5. Did not receive chemotherapy 14 days before the first treatment (if you are undergoing chemotherapy and need to end the chemotherapy 14 days before entering the group); 6. Sign the informed consent form voluntarily.

Exclusion criteria

Exclusion criteria: Non-small cell lung cancer group: 1. Combined with severe immune function (such as HIV infection) and cannot be improved in the short term; 2. Combined with HBV, HCV, tuberculosis (pulmonary tuberculosis, renal tuberculosis, etc.), syphilis and other infections; 3. The history of primary tumors in other organs; 4. ECOG classification (attached to the classification standard) >= 3; 5. The blood routine indexes and immune function of the body are obviously abnormal, and they cannot be improved after medical adjustment (white blood cell count 10 x 10^9/L, hemoglobin 1.5 times the upper limit of normal; liver function: transaminase exceeds 5 times the upper limit of normal); 6. A clinically significant cardio-cerebral blood disease episode occurred within 6 months before clinical registration, such as myocardial infarction, hemorrhagic or ischemic stroke, etc.; 7. Existence of pulmonary encephalopathy or combined with insufficiency, failure, or serious primary disease of important organs (heart, liver, kidney, etc.); 8. Combined with severe mental illness; 9. There is an active infection (virus or bacteria); 10. Women who are pregnant, breastfeeding or have a pregnancy plan within six months; 11. People with extreme allergies; 12. Are or will participate in other clinical trials; 13. The researcher believes that it is inappropriate to participate in this trial. Breast cancer group: 1. Combined with severe immune function (such as HIV infection); combined with HBV, HCV, tuberculosis (tuberculosis, renal tuberculosis, etc.), syphilis and other infections; 2. The history of primary tumors in other organs; 3. ECOG classification (attached to the classification standard) >= 3; 4. The blood routine index and immune function of the body are obviously abnormal, and they cannot be improved after medical adjustment (white blood cell count 10 x 10^9/L, hemoglobin 1.5 times the upper limit of normal; liver function: transaminase exceeds 5 times the upper limit of normal); 5. A clinically significant cardio-cerebral hemorrhage event occurred within 6 months before clinical registration, such as myocardial infarction, hemorrhagic or ischemic stroke; 6. Combined with insufficiency, failure, or serious primary disease of important organs (heart, lung, liver, kidney, blood, metabolism, etc.); 7. Combined with severe mental illness; 8. There are active infections (viruses or bacteria), such as lung infections, severe systemic infections, etc.; 9. Women who are pregnant, breastfeeding or have pregnancy plans within six months; 10. People with extreme allergies; 11. Are or will participate in other clinical trials; 12. The researcher believes that it is inappropriate to participate in this trial. Hepatocellular carcinoma group: 1. In the initial treatment, there are serious complications such as distant metastatic liver cancer, hepatic encephalopathy, gastrointestinal bleeding, massive ascites, other viral infections, alcoholic, drug-induced liver diseases; 2. Combined with se

Design outcomes

Primary

MeasureTime frame
Safety evaluation index;Effectiveness evaluation index;

Secondary

MeasureTime frame
Progression-free survival (PFS);Overall survival (OS);Immunological index;Tumor markers;

Countries

China

Contacts

Public ContactTian Huaqin

Foshan Traditional Chinese Medicine Hospital

13929969262@139.com+86 13929969262

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026