the Predictive Value of Immune Cell in Locally Advanced Cervical Cancer

• ClinicalTrials.gov Identifier: NCT06378840
• Recruitment Status: Recruiting
• First Posted: April 23, 2024
• Last Update Posted: April 23, 2024
• Sponsor: RenJi Hospital
• Information provided by (Responsible Party): RenJi Hospital

Tracking Information

• First Submitted Date: April 10, 2024
• First Posted Date: April 23, 2024
• Last Update Posted Date: April 23, 2024
• Actual Study Start Date: January 1, 2022
• Estimated Primary Completion Date: December 30, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 18, 2024)

• the change of immune cells in the blood after chemoradiotherapy and immunotherapy [ Time Frame: 1 year ]
  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.
• the predictive value of the changed immune cell subtype in the blood on the side effect of immunotherapy [ Time Frame: 1 year ]
  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.
• the predictive value of the changed immune cell subtype in the blood on the effect of chemoradiotherapy and immunotherapy [ Time Frame: 2 years ]
  through statistical analysis, the investigators try to figure out if there is any immune subtype or any special molecular to a possible biomarker of disease control (disease progression or not accordingly to the RECIST criterion)

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: April 18, 2024)

• the change of immune cells in the tissue after chemoradiotherapy [ Time Frame: 1 year ]
  through single-cell sequence and data analysis, the investigators will focus on the percentage of each sub-type of immune cells in the tumor microenvironment and differential gene expression profiles in special cell type after chemoradiotherapy.
• the predictive value of the changed immune cell subtype in the tissue on the effect of chemoradiotherapy and immunotherapy [ Time Frame: 2 years ]
  through statistical analysis, the investigators try to figure out if there is any immune subtype or any special molecular in the tumor tissue to a possible biomarker of disease control (disease progression or not accordingly to the RECIST criterion)
• the predictive value of the changed immune cell subtype in the tumor microenvironment on the side effect of immunotherapy [ Time Frame: 1 year ]
  through statistical analysis, the investigators try to figure out if there is any immune subtype or any special molecular in the tumor tissue to a possible biomarker of the occurrence of any immunotherapy-related side effect.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: the Predictive Value of Immune Cell in Locally Advanced Cervical Cancer
• Official Title: 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
• 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.
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples With DNA

Description:

tissue and blood sample

• Sampling Method: Non-Probability Sample
• Study Population: locally advanced cervical carcinoma

Condition

• Locally Advanced Cervical Carcinoma
• Concurrent Chemoradiotherapy
• Immunotherapy

Intervention

Radiation: Nab-paclitaxel/Platinum, Sintilimab

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

• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 18, 2024): 20
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 30, 2024
• Estimated Primary Completion Date: December 30, 2024 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Yongrui Bai, Dr.; 86-2-68383459; baiyongrui@renji.com

• Listed Location Countries: China

Administrative Information

• NCT Number: NCT06378840
• Other Study ID Numbers: KY2021-268-B
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: RenJi Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: RenJi Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: RenJi Hospital
• Verification Date: April 2024