the Predictive Value of Immune Cell in Locally Advanced Cervical Cancer

NCT06378840 | Recruiting FDA Device

• 1 other identifier: KY2021-268-B
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Locally Advanced Cervical Carcinoma; Concurrent Chemoradiotherapy; Immunotherapy

Outcome Measures

Primary Outcomes (3)

• the change of immune cells in the blood after chemoradiotherapy and immunotherapy

  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.

  1 year

• the predictive value of the changed immune cell subtype in the blood on the side effect of immunotherapy

  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.

  1 year

• the predictive value of the changed immune cell subtype in the blood on the effect of chemoradiotherapy and immunotherapy

  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)

  2 years

Secondary Outcomes (3)

• the change of immune cells in the tissue after chemoradiotherapy

  1 year

• the predictive value of the changed immune cell subtype in the tissue on the effect of chemoradiotherapy and immunotherapy

  2 years

• the predictive value of the changed immune cell subtype in the tumor microenvironment on the side effect of immunotherapy

  1 year

Interventions

Nab-paclitaxel/Platinum, Sintilimab RADIATION

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

locally advanced cervical carcinoma

You may qualify if:

• Age between 18 and 75;
• Untreated patients with pathologically proven locally advanced cervical cancer;
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
• Adequate hematological, renal and hepatic functions:
• 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
• Life expectancy \> 6 months
• Eligible for concurrent chemoradiotherapy assessed by principle investigator;
• No obvious active bleeding;
• Written informed consent must be available before study registration

You may not qualify if:

• Recurrent or distant metastatic disease;
• Prior malignancies (other than curable non-melanoma skin cancer) within 5 years;
• Active autoimmune diseases requiring systemic treatment or other diseases requiring long-term use of substantial amount of hormones or other immunosuppressants;
• 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;
• Vaccination of live attenuated vaccine 30 days before enrollment, or planned vaccination of live attenuated vaccine during the study;
• Previous organ transplantation or HIV patients;
• Allergic to macromolecular proteins /monoclonal antibodies, or to any test drug component;
• 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.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

RenJi hospital

Shanghai, 200127, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

tissue and blood sample

MeSH Terms

Interventions

130-nm albumin-bound paclitaxel; Platinum; sintilimab

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Central Study Contacts

Yongrui Bai, Dr.

CONTACT

86-2-68383459; baiyongrui@renji.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: April 23, 2024
• Study Start: January 1, 2022
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: April 23, 2024

Record last verified: 2024-04

Locations

CN (1)