Advanced solid tumors
Conditions
Interventions
Experimental Group:Dual blockade combined DC-T cells
Sponsors
Army Medical Center of PLA
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients with advanced solid tumors diagnosed by pathology who cannot be operated on or surgically removed. The patients have previously received >= first-line standard systemic treatment, and who do not have a standard treatment plan according to the current Guidelines of the Chinese Association of Clinical Oncology (CSCO) or the consensus of Chinese experts (if special patients cannot be determined by referring to the existing guidelines, they need to be decided through the MDT team composed of doctors of oncology, surgery, radiotherapy and tumor immunotherapy group); 2. According to the RECIST 1.1 standard, the patient should have at least one target lesion with measurable diameter (CT scan length and diameter of tumor lesions >= 10 mm, the short diameter of lymph node lesions >= 15 mm; the scan layer thickness is not more than 5 mm; and no local treatment has been received); 3. The patient is willing to undergo re-biopsy and can provide more than 20 fresh thick needle puncture specimens or FFPE slices; 4. Age: range from 18 to 75 years; 5. ECOG score: 0-2 points; 6. Expected survival time >= 3 months; 7. The damaged lesions caused by receiving other treatments have restored, of which the interval period between receiving nitroso or mitomycin should be or more than 6 weeks, or receiving other cytotoxic drugs, radiotherapy or surgery should be or more than 4 weeks, and the wounds have completely healed.
Exclusion criteria
Exclusion criteria: 1. Suffering from other malignant tumors in the past or at the same time, except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix; 2. Tumor patients with positive driver genes who have not received standard targeted drug therapy, non-small cell lung cancer including EGFR, ALK, ROS-1, melanoma including BRAF, etc. The remaining positive driver genes need to be confirmed by the test doctor exclude; 3. Patients who have previously received cell therapy or including but not limited to CAR-T therapy; 4. Subjects with active, known or suspected autoimmune diseases. Subjects with type 1 diabetes, hypothyroidism requiring only hormone replacement therapy, skin disorders that do not require systemic therapy (such as vitiligo, psoriasis, or alopecia) or diseases that are not expected to recur without external stimuli may selected; 5. Subjects who need systemic treatment with glucocorticoids (> 10 mg prednisone equivalent per day) or other immunosuppressive drugs within 14 days before randomization. If there is no active autoimmune disease, the use of inhaled or topical steroids and adrenal hormone replacement therapy at a dose equivalent to > 10 mg prednisone per day are allowed; 6. The subject has interstitial lung disease, which is symptomatic or may hinder the detection or management of drug-related pulmonary toxicity; 7. Known human immunodeficiency virus (HIV) positive medical history or known acquired immunodeficiency syndrome (AIDS). Any positive test result for hepatitis B virus or hepatitis C virus, suggesting acute or chronic infection; 8. Those with allergic constitution or history of allergy to protein biological products; 9. Patients with evidence of central nervous system metastasis or previous history of central nervous system metastasis at baseline. For patients with clinically suspected central nervous system metastases, CT or MRI scans must be performed within 14 days before randomization to exclude central nervous system metastases; 10. The main organ function is abnormal, that is, the relevant inspection indicators reach the following levels: (1) Blood routine examination: 1) HB = 1.25 x ULN (upper limit of normal value); 2) ALT or AST >= 1.5 x ULN; if there is liver metastasis, ALT or AST >= 2.5 x ULN; 3) Endogenous creatinine clearance 1.5 x ULN; Triglyceride > 2.5 x ULN; (3) Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) 140 mmHg, diastolic blood pressure > 90 mmHg), suffering from grade I or above myocardial ischemia or myocardial infarction, arrhythmia (including QTcF: male >= 450 ms, women >= 47 0ms) and cardiac insufficiency; 12. Urine routine prompts urine protein >= ++ and confirmed 24-hour urine protein quantity > 1.0 g; 13. Long-term unhealed wounds or incompletely healed fractures; 14. Abnormal blood coagulation function and bleeding tendency (14 days before randomization must meet: INR is within the normal range without using anticoagulants); 15. Hyperactive/venous thrombosis events occurred within one year before screening, such as cerebrovascular accidents (including transient ischemic attacks), deep vein
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vital Sign monitoring;Disease control rate, DCR;Physical Examination;Laboratory Testing;Adverse Events;Progression-Free Srvival, PFS; | — |
Countries
China
Contacts
Public ContactXiang Xu
Army Medical Center of PLA
Outcome results
None listed