Clinical Study on Optimization of Postoperative Adjuvant Therapy for Cervical Cancer Based on MRD

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This study is a prospective cohort clinical trial that aims to investigate the safety and efficacy of a combined chemoradiotherapy and immunotherapy treatment for early postoperative cervical cancer. Specifically, this study seeks to evaluate the ability of MRD-based screening to detect and monitor changes in MRD status at different stages of treatment, its potential for use in monitoring patient recurrence rates and in prognosis evaluation. In addition, this study will investigate the safety and effectiveness of chemoradiotherapy combined with immunotherapy as a postoperative adjuvant therapy for patients identified to be at risk of early cervical cancer based on MRD screening.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients with histopathological and clinical (FIGO 2018) stage ⅠB2 \

⁃ II A2 cervical cancer.

• Above the age of 18.

• General status: ECOG score 0-2.

• Be able to understand the research scheme, voluntarily participate in the study, and sign the informed consent.

• Good compliance, able to cooperate with the collection of specimens at each node and provide corresponding clinical information.

Locations
Other Locations
China
The Affiliated Suzhou Hospital of Nanjing Medical University
RECRUITING
Suzhou
Contact Information
Primary
jing xue
jxue@njmu.edu.cn
(+86)13771734347
Time Frame
Start Date: 2023-01-16
Estimated Completion Date: 2028-12-30
Participants
Target number of participants: 32
Treatments
Experimental: Arm A
Eligible subjects were assigned to high-risk or medium-risk groups based on Peter's criteria and Sedlis criteria. Patients with a high-risk classification or MRDc0 (+) status received a treatment consisting of conventional pelvic concurrent chemoradiotherapy, adjuvant chemotherapy, four courses of immunotherapy, continued immunotherapy with MRDIn(+), and follow-up monitoring with MRDIn(-)
Experimental: Arm B
Patients deemed intermediate risk and with MRDc0 (-) status received concurrent chemoradiotherapy in the small pelvic target volume, four courses of immunotherapy, continued immunotherapy with MRDIn(+), and follow-up monitoring with MRDIn(-)
Related Therapeutic Areas
Sponsors
Leads: Suzhou Municipal Hospital

This content was sourced from clinicaltrials.gov