Cervical Cancer
Conditions
Interventions
Group 2:autologous cellular immunotherapy + Radio-chemotherapy
Group 1:Radio-chemotherapy
Sponsors
Beijing Hospital
Eligibility
Sex/Gender
Female
Age
25 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Be willing and able to provide written informed consent for the trial; 2. Female subjects aged 25-75 years; 3. Subjects are able to complete three autogenous CentricT cellular immunotherapy; 4. Subjects with pathologically and radiographically confirmed stage IIB-IV, recurrent or metastatic cervical cancer with pathologically confirmed new local lesions or metastatic lesions after radiotherapy or chemotherapy (CR, PR or SD); 5. At least one measurable lesion (per RECIST 1.1 criteria, tumor CT scan length diameter =10 mm, lymph node CT scan short diameter =15 mm); 6. Subjects who have not received cellular immunotherapy within 6 months; 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 3; 8. Subjects without significant cardiovascular and lung disease, and can tolerate radiotherapy or chemotherapy; 9. Adequate Liver and kidney function: (1) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) = 2.5 the upper limit of normal (ULN) for the institution; (2) Total bilirubin (TBIL) = 1.5 the upper limit of ULN; (3) Serum creatinine (CREA) = 1.5 the upper limit of ULN; 10. Subjects meet the indications of CentricT cellular immunotherapy; 11. Female subjects of child-bearing age must have been using reliable contraception, or have had a negative blood pregnancy test within 1 week, and be willing to use appropriate contraception during the trial and 8 weeks after the last administration of immunotherapy.
Exclusion criteria
Exclusion criteria: 1. Subjects with severe abnormality of coagulation; 2. Subjects with thrombotic diseases; 3. Subjects with hematological malignancy; 4. Subjects meet the contraindications of CentricT cellular immunotherapy; 5. Autologous bone marrow transplantation (ABMT) < 4 weeks of starting study treatment; 6. Concurrent treatment on another clinical trial or treatment on another clinical trial < 4 weeks of starting study treatment; 7. There are drug abuse, medical treatment, mental illness and social disorders that would interfere with subjects' participation, or confound the results of the trial; 8. Subjects with concomitant diseases that are serious hazards to the safety of patients or affec patients to complete the study; 9. Any condition that would interfere with or endanger the safety and compliance of subjects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| one year survival rate;two year survival rate; | — |
Countries
China
Contacts
Public ContactQiubo Lu
Beijing Hospital
Outcome results
None listed