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Phase I clinicalstudyof Immunotherapy Using Autologous Tumor Infiltrating Lymphocytes stimulated by dendritic cells for Patients with Solid Tumors

Phase I clinicalstudyof Immunotherapy Using Autologous Tumor Infiltrating Lymphocytes stimulated by dendritic cells for Patients with Solid Tumors

Status
Active, not recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OIN-17012386
Enrollment
Unknown
Registered
2017-08-16
Start date
2017-09-01
Completion date
Unknown
Last updated
2017-08-21

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

Conditions

Malignant solid tumor

Interventions

Intervention group:Autologous DC-TIL Immunotherapy

Sponsors

Gansu Provincial Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 70 years; 2. Histopathologically diagnosed as solid malignancy; 3. Availability of tumor tissueorLymph node, for maturing dendritic cells; 4. ECOG PS: 0-2; 5. Multiple organ function assessment: (without blood transfusion in 14 days) HB = 90g/L; ANC = 1.5 × 10^9/L; PLT = 80×10^9/L; BIL<1.5×upper limit of normal (ULN)and ALT <5×ULN and AST <2.5×ULN; if liver metastasis,serum Cr = 1×ULN, endogenous creatinine clearance =50ml/min (Cockcroft-Gault formula); 6. Life expectancy of greater than six months; 7. No active infection within two weeks; 8. Physician plans to use TIL treatment; 9. Consent to participate in clinical trials, Having full capacity for civil conduct.

Exclusion criteria

Exclusion criteria: 1. patients with severe liver and kidney dysfunction; 2. patients with heart failure; 3. severe pulmonary dysfunction; 4. Having an autoimmune disease, need immunosuppressive agents or hormone therapy; 5. Serious uncontrolled infection, or other serious uncontrolled concomitant disease; 6. The HIV positive; 7. Coagulation dysfunction (INR> 1.5 ULN, APTT> 1.5 ULN), with bleeding tendency or active bleeding patients; 8. active brain metastases; 9. Allergy to any interferon, interleukin 2 and other drug ingredients in the study; 10. Pregnancy or nursing females; 11. T cell-associated lymphoma and leukemia patients; 12. Physicians believe that patients are not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
progression-free survival;disease control rate;

Secondary

MeasureTime frame
Overall survival;

Countries

China

Contacts

Public ContactXue Xiaodong

Gansu Provincial Hospital

xiaodongxue@hotmail.com+86 0931-8281913

Outcome results

None listed

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