Clinical trial · Observational
the Predictive Value of Immune Cell in Locally Advanced Cervical Cancer
An Exploratory Analysis of the Predictive Value of Immune Cell Using Single-cell Sequencing on the Outcome of Locally Advanced Cervical Cancer Treated by Concurrent Chemoradiotherapy Followed by PD-1 Inhibitor
NCT06378840CI-TRIAL-00076361unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To explore the predictive value of immune cells by single-cell sequencing on the outcome of locally advanced cervical cancer treated by concurrent chemoradiotherapy Followed by PD-1 inhibitor
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Concurrent Chemoradiotherapy | — | UNRESOLVED | — |
| Immunotherapy | — | UNRESOLVED | — |
| Locally Advanced Cervical Carcinoma | Cervical Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nab-paclitaxel/Platinum, Sintilimab | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- the change of immune cells in the blood after chemoradiotherapy and immunotherapy
- timeFrame
- 1 year
- description
- through single-cell sequence and data analysis, the investigators will focus on the percentage of each sub-type of immune cells after treatment, differential gene expression profiles in special cell type after chemoradiotherapy and immunotherapy.
- measure
- the predictive value of the changed immune cell subtype in the blood on the side effect of immunotherapy
- timeFrame
- 1 year
- description
- the investigators will focus on the occurrence and grade of side effect from immunotherapy according to the NCCN clinical practice guidelines in the evaluation and management of immunotherapy-related toxicity (through the symptoms, physical examination, and also through blood/image/endoscopy examination, such as blood routine, liver and renal function, TSH/T3/T4/ACTH concentration, myocardial enzymes concentration, EKG, echocardiography, CT/MRI, et al). And through statistical analysis, the investigators try to figure out if there is any immune subtype or any special molecular to a possible biomarker of the occurrence of any immunotherapy-related side effect.
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion criteria: 1. Age between 18 and 75; 2. Untreated patients with pathologically proven locally advanced cervical cancer; 3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 4. Adequate hematological, renal and hepatic functions: 4.1 Hemoglobin \> 8.0 g/dl 4.2 Neutrophils \> 2000 cells/μl; Leukocytes \> 4 × 109/L 4.3 Platelets \> 100 × 109/Lg. 4.4 Serum urea nitrogen (BUN) ≤ 1.5 × upper normal limit (UNL) 4.5 Serum creatinine (Cr) ≤ 1.5 × upper normal limit (UNL) 4.6 Serum ALT/AST ≤ 2.5× UNL 4.7 Serum Total bilirubin ≤ 1.5× UNL 5. Life expectancy \> 6 months 6. Eligible for concurrent chemoradiotherapy assessed by principle investigator; 7. No obvious active bleeding; 8. Written informed consent must be available before study registration Exclusion criteria: 1. Recurrent or distant metastatic disease; 2. Prior malignancies (other than curable non-melanoma skin cancer) within 5 years; 3. Active autoimmune diseases requiring systemic treatment or other diseases requiring long-term use of substantial amount of hormones or other immunosuppressants; 4. Patients who need to receive systemic corticosteroids (dose equivalent to or higher than prednisone 10mg qd) or other immunosuppressants within 14 days before enrollment or during the study; 5. Vaccination of live attenuated vaccine 30 days before enrollment, or planned vaccination of live attenuated vaccine during the study; 6. Previous organ transplantation or HIV patients; 7. Allergic to macromolecular proteins /monoclonal antibodies, or to any test drug component; 8. Active acute or chronic viral hepatitis B or C. Hepatitis B virus (HBV) DNA\> 2000IU/ml or 104 copies/ml; hepatitis C virus (HCV) RNA\> 103 copies/ml.
References
Publications (0)
Data not yet available
No reference posted for this study.