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An exploratory analysis of the predictive value of immune cell on the outcome of locally advanced cervical cancer treated by concurrent chemoradiotherapy (with nab-paclitaxel/cisplatin) Followed by PD-1 inhibitor

An exploratory analysis of the predictive value of immune cell on the outcome of locally advanced cervical cancer treated by concurrent chemoradiotherapy (with nab-paclitaxel/cisplatin) Followed by PD-1 inhibitor

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200056704
Enrollment
Unknown
Registered
2022-02-10
Start date
2022-02-15
Completion date
Unknown
Last updated
2023-09-11

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

Conditions

Cervical cancer

Interventions

Treatment group:CCRT followed by PD-1 inhibitor

Sponsors

Renji Hospital, Shanghai Jiao Tong university, School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Aged 18 years old or more; 2. Patients must have histologically confirmed cervical cancer with adenocarcinoma, adenosquamous or squamous histology, and FIGO 2018 III-IVA. 3. ECOG score: 0-2; 4. No obvious signs of hematological diseases, ANC>=1.5*10^9/L, platelet count>=100*10^9/L, Hb>=90g/L, WBC>=3.0*10^9/L, and no bleeding tendency before enrollment; 5. Adequate hepato-renal function is needed, including Total bilirubin (TBIL)= 50mL/min 6. Patients voluntarily participated in the study and signed informed consent; 7. For patients with the possibility of pregnancy, blood or urine test should be taken to rule out pregnancy and should receive contraceptive measures during treatment.

Exclusion criteria

Exclusion criteria: 1. Patients with distant metastasis; 2. Previous treatment with nab-paclitaxel; 3. Previous abdomen or pelvic radiotherapy; 4. Suffering from mental illness, including epilepsy, dementia, severe depression, mania, etc; 5. Patients with other malignant tumors in the previous 5 years; 6. Patients with >= grade 2 peri-neural disease; 7. Patients with heart failure (NYHA class III or IV) and poor control of coronary artery disease or arrhythmia, or a history of myocardial infarction within 6 months prior to screening, despite appropriate drug treatment; 8. Uncontrolled diabetus; 9. Uncontrolled HBV infection; 10. HCV or HIV infection; 11. Active immunodeficiency diseases, which needs systemic immune inhibitor or steroids; 12. Autoimmune thyroiditis; 13. Previouse treatment of cancer-vacination, cytokine, anti CTLA-4, PD-1, PD-L1 inhibitor or analogs; 14. The researcher thinks that the patient is not suitable to participate in this experiment.

Design outcomes

Primary

MeasureTime frame
Predictive value of immune cell;—

Countries

china

Contacts

Public ContactYongrui Bai

Renji Hospital, Shanghai Jiao Tong university, School of Medicine

baiyongrui@renji.com+86 13301013916

Outcome results

None listed

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