the Predictive Value of Immune Cell in Locally Advanced Cervical Cancer

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Locally Advanced Cervical Carcinoma; Immunotherapy; Concurrent Chemoradiotherapy

Treatments: Radiation: Nab-paclitaxel/Platinum, Sintilimab

Study type: Observational

Funder types: Other

Identifiers

NCT06378840

KY2021-268-B

Details and patient eligibility

About

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

Full description

Concurrent chemoradiotherapy is the standard treatment for patients with locally advanced cervical cancer, but the treatment failure rate is up to 40% in previous studies. Immunotherapy using PD-1 inhibitor showed an objective response rate of 12-50% in studies, and pembrolizumab was approved by the US Food and Drug Administration for patients with advanced PD-L1-positive cervical cancer who experienced progression during or after chemotherapy. And according to KEYNOTE-A18, the addition of PD-1 inhibitor Pembrolizumab to the current concurrent chemoradiotherapy improved the PFS of such group of patients. But the detailed change of immune cells (tumor microenvironment and PBMC) during treatment is unknown, and studies on the relationship between immune cells and treatment-related side effect and efficiency is also in need.

Enrollment: 20 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.