Clinical trial · Interventional
Optimization of Postoperative Adjuvant Therapy for Cervical Cancer Based on MRD(Minimal Residual Disease)
Clinical Study on Optimization of Postoperative Adjuvant Therapy for Cervical Cancer Based on MRD
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemoradiotherapy + Adjuvant chemotherapy and Zimberelimab | Drug | — | UNRESOLVED |
| Chemoradiotherapy (small pelvic) + Zimberelimab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- 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(-)
- interventionNames
- Drug: Chemoradiotherapy + Adjuvant chemotherapy and Zimberelimab
- type
- EXPERIMENTAL
- label
- Arm B
- description
- 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(-)
- interventionNames
- Drug: Chemoradiotherapy (small pelvic) + Zimberelimab
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available