the Predictive Value of Immune Cell in Locally Advanced Cervical Cancer

NCT ID: NCT06378840

Last Updated: 2024-04-23

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2024-12-30

Brief Summary

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

Detailed 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.

Conditions

Locally Advanced Cervical Carcinoma; Concurrent Chemoradiotherapy; Immunotherapy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Nab-paclitaxel/Platinum, Sintilimab

Sintilimab Combined With Concurrent Nab-paclitaxel/Platinum-based Chemoradiotherapy

Intervention Type: RADIATION

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

RenJi hospital

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Yongrui Bai, Dr.

Role: CONTACT

baiyongrui@renji.com

86-2-68383459

Facility Contacts

Haiyan Chen, Dr

Role: primary

chenhaiyan@renji.com

+862168383624

Other Identifiers

KY2021-268-B

Identifier Type: -

Identifier Source: org_study_id