Optimizing postoperative therapy for cervical cancer using MRD screening
Clinical Study on Optimization of Postoperative Adjuvant Therapy for Cervical Cancer Based on MRD
This study is testing a new treatment plan that combines chemotherapy and immunotherapy for patients with early cervical cancer to see if it helps them recover better and reduces the chance of cancer coming back.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Suzhou Municipal Hospital Academic / other |
| Drugs / interventions | immunotherapy, chemotherapy |
| Locations | 1 site (Suzhou, Jiangsu) |
| Trial ID | NCT05872724 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and efficacy of a combined treatment approach involving chemoradiotherapy and immunotherapy for patients with early postoperative cervical cancer. It focuses on using MRD (Minimal Residual Disease) screening to detect and monitor changes in MRD status throughout treatment, aiming to improve prognosis and recurrence monitoring. The study is structured into three periods: screening, treatment, and follow-up, with participants categorized into high-risk and intermediate-risk groups based on specific criteria. Treatment regimens vary according to risk classification, incorporating conventional therapies and immunotherapy.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with stage ⅠB2 to II A2 cervical cancer and an ECOG score of 0-2.
Not a fit: Patients with other malignant tumors, autoimmune diseases, or those unable to comply with the study's follow-up requirements may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment outcomes and reduce recurrence rates for patients with cervical cancer.
How similar studies have performed: While the use of MRD screening in cervical cancer is a novel approach, similar methodologies in other cancers have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with histopathological and clinical (FIGO 2018) stage ⅠB2 \~II A2 cervical cancer. 2. Above the age of 18. 3. General status: ECOG score 0-2. 4. Be able to understand the research scheme, voluntarily participate in the study, and sign the informed consent. 5. Good compliance, able to cooperate with the collection of specimens at each node and provide corresponding clinical information. Exclusion Criteria: 1. Suffering from other malignant tumors. 2. Do not receive the specified treatment or change the treatment regimen before the disease progresses. 3. The study cannot be followed up according to the defined clinical follow-up period. 4. Unable to accept or provide CT or other designated therapeutic evaluation means. 5. Have an autoimmune disease.
Where this trial is running
Suzhou, Jiangsu
- The Affiliated Suzhou Hospital of Nanjing Medical University — Suzhou, Jiangsu, China (Recruiting)
Study contacts
- Principal investigator: jing xue — The Affiliated Suzhou Hospital of Nanjing Medical University
- Study coordinator: jing xue
- Email: jxue@njmu.edu.cn
- Phone: (+86)13771734347
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.