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A prospective open single arm clinical study of evaluating the efficacy and safety of gp96 antigen peptide complex sensitized dendritic cells in the treatment of solid tumor

A prospective open single arm clinical study of evaluating the efficacy and safety of gp96 antigen peptide complex sensitized dendritic cells in the treatment of solid tumor

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONC-16008880
Enrollment
Unknown
Registered
2016-07-22
Start date
2016-08-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Solid tumors

Interventions

GPDC treatment group:basal treatment

Sponsors

The second people's hospital of Neijiang
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years old; 2. Histologically confirmed solid tumors; 3. Fresh tumor tissue =6g; 4. ECOG PS 0-2; 5. The main organ function properly and meet the following requirements: blood tests must meet(within 14 days without blood transfusion) HB=90g/L; ANC =1.5×10^9/L; PLT =80 ×10^9/L; biochemical tests subject to the following criteria: BIL <1.5 times the upper limit of normal (ULN); ALT and AST <2.5 ×ULN; if liver metastases, the ALT and AST <5 ×ULN; serum Cr=1 ×ULN, creatinine clearance =50ml / min (Cockcroft-Gault formula); 6. The expected survival = 6 months; 7. No active infection within two weeks; 8. Treating physician plans to use GPDC; 9. Patient volunteered to join the study and signed informed consent (ICF).

Exclusion criteria

Exclusion criteria: 1. patients with severe liver or kidney dysfunction or heart failure; 2. patients with autoimmune disease that need for systemic use of immunosuppressive agents or hormone therapy; 3. patients experienced adverse reactions, or serious adverse events; 4. abnormal coagulation function (INR>1.5 * ULN, ULN * APTT>1.5), with bleeding tendency or active bleeding patients; 5. there are active brain metastases; 6. tumor tissue < 6g, unable to prepare gp96 antigen peptide complex; 7. Contamination occurred during gp96 antigen peptide complex preparation(including bacteria, viruses, fungi, etc.); 8. Contamination occurred during DC extraction or in vitro sensitization DC(including bacteria, viruses, fungi, etc.); 9. storage transport of gp96 antigen peptide complex or DC is not in accordance with the requirements of the experiment; 10. patients voluntarily withdraw from this study; 11. pregnant or lactating women; 12. Other treating physician believes the patient is not fit for inclusion.

Design outcomes

Primary

MeasureTime frame
Fundus examination;Liver function damage;Renal function damage;Body temperature rise;Autologous antibody;Immunology index;

Secondary

MeasureTime frame
Disease control rate;Objective remission rate;Progression free survival;overallsurvival;Time To Progress;Quality of life;

Countries

China

Contacts

Public ContactOu Jiang

The second people's hospital of Neijiang

jiangou816@163.com+86 13990570757

Outcome results

None listed

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