Exploring immune cell predictors in advanced cervical cancer treatment

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

This study is trying to see if changes in immune cells can help predict how well treatment works for people with advanced cervical cancer who are receiving chemotherapy and a new type of immunotherapy.

Quick facts

• Study type: Observational
• Enrollment: 20 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: RenJi Hospital (Academic / other)
• Drugs / interventions: prednisone, pembrolizumab, chemotherapy, Immunotherapy
• Locations: 1 site (Shanghai)
• Trial ID: NCT06378840 on ClinicalTrials.gov

What this trial studies

This observational study investigates the predictive value of immune cells in patients with locally advanced cervical cancer undergoing concurrent chemoradiotherapy followed by a PD-1 inhibitor. The research aims to understand how changes in immune cells during treatment relate to treatment outcomes and side effects. By utilizing single-cell sequencing, the study seeks to provide insights into the tumor microenvironment and the effectiveness of immunotherapy in this patient population.

Who should consider this trial

Good fit: Ideal candidates are untreated patients aged 18 to 75 with pathologically confirmed locally advanced cervical cancer and an ECOG performance status of 0-1.

Not a fit: Patients with recurrent or metastatic disease or those with active autoimmune diseases requiring systemic treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance treatment strategies for locally advanced cervical cancer by identifying immune cell profiles that predict better outcomes.

How similar studies have performed: Previous studies have shown promising results with immunotherapy in cervical cancer, indicating potential for success with this approach.

Eligibility criteria

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.

Where this trial is running

Shanghai

• RenJi hospital — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Yongrui Bai, Dr.

Conditions Locally Advanced Cervical Carcinoma; Concurrent Chemoradiotherapy; Immunotherapy