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.
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.
Suffering from other malignant tumors.
Do not receive the specified treatment or change the treatment regimen before the disease progresses.
The study cannot be followed up according to the defined clinical follow-up period.
Unable to accept or provide CT or other designated therapeutic evaluation means.
Parallel
Chemoradiotherapy + Adjuvant chemotherapy and Zimberelimab
Drug* Radiation therapy: 1\. Irradiation mode and dose: 6MV-X-ray (6Megavoltage-X-ray), IMRT or RapidArc-IMRT were used for external radiotherapy. External radiotherapy dose: PTV (Planning Target Volume) 45-50Gy/25 times. * Chemotherapy: 1. Concurrent chemotherapy: Cisplatin monotherapy: DDP 75 mg/m2 for 3 days, q3w. Carboplatin or nedaplatin may be used in patients that cannot tolerate cisplatin. 2. Adjuvant chemotherapy: After the concurrent chemoradiotherapy, 4 cycles of consolidation chemotherapy plus immunotherapy are recommended for patients with high risk or MRDc0 (+). Recommended chemotherapy regimen: liposome paclitaxel 135mg/m2 d1 +DDP 25 mg/m2 D1-3, Q21. * Zimberelimab injection: 240 mg, IV, q3w. Start the drug one day before the start of postoperative radiotherapy.
Chemoradiotherapy (small pelvic) + Zimberelimab
DrugRadiation therapy: 1\. Target volume of radiotherapy for small pelvis: CTVp includes tumor bed area, paracentral area and part of vagina; CTVn includes bilateral internal iliac, external iliac and obturator lymphatic drainage areas. Upper boundary to sacroiliac joint level, lower boundary to 2cm below vaginal stump. Chemotherapy: Concurrent chemotherapy: Cisplatin monotherapy: DDP 75 mg/m2 for 3 days, q3w. Carboplatin or nedaplatin may be used in patients that cannot tolerate cisplatin. Adjuvant chemotherapy: After the concurrent chemoradiotherapy, 4 cycles of adjuvant immunotherapy are recommended for patients in good general condition (ECOG: 0-1) with medium risk and MRDc0 (-). Zimberelimab injection: 240 mg, IV, q3w. Start the drug one day before the start of posterior radiotherapy.
3-year DFS in ITT population (intent-to-treat population)
DFS (disease-free survival) is the time between the start of enrollment and the recurrence of disease, or death from any cause.
3-year DFS with different MRD status and changes
DFS (disease-free survival) is the time between the start of enrollment and the recurrence of disease, or death from any cause
2-year DFS with different MRD status and changes
DFS (disease-free survival) is the time between the start of enrollment and the recurrence of disease, or death from any cause
1-year DFS with different MRD status and changes
DFS (disease-free survival) is the time between the start of enrollment and the recurrence of disease, or death from any cause
3-year OS rates in patients with different MRD status and changes
OS (overall survival) is the overall time from enrollment to death from any cause
Disease recurrence based on MRD monitoring methods
The time from MRD(-) to MRD(+)
Negative conversion rate of MRD (+) patients after intensive adjuvant therapy
Incidence of conversion from MRD(+) to MRD(-) after adjuvant therapy
To explore the correlations of genes detected by next-generation sequencing, MRI-based response patterns and biomarkers of peripheral blood with the efficacy of treatment.
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