Camrelizumab combined with chemotherapy as postoperative adjuvant therapy after radical surgery for cervical cancer patients with pathologically positive lymph nodes: a prospective multicenter phase II clinical trial.
Concurrent chemoradiotherapy is the standard adjuvant treatment for cervical cancer patients with pathologically confirmed lymph node metastases (International Federation of Gynecology and Obstetrics 2018 stage IIIC1p or IIIC2p) after radical surgery. Yet distant metastasis remains the predominant pattern of failure. In recent years, Immune checkpoint inhibitors combined with platinum-containing chemotherapy has been increasingly valued in the treatment of cervical cancer. Yet the role of postoperative chemo-immunotherapy in this setting remains unclear. There is no high-quality evidence-based evidence.
This multicenter, prospective, single-arm phase II clinical trial is to evaluate the safety and preliminary efficacy of postoperative chemo-immunotherapy in cervical cancer patients with pathologically confirmed lymph node metastasis after radical hysterectomy, and to explore potential biomarkers associated with treatment response. Fifty-nine carefully selected cervical cancer patients with pathologically confirmed lymph node metastases and programmed death ligand-1 positivity (combined positive score ≥1) after radical surgery will be enrolled. Postoperative treatment is initiated 2-3 weeks after surgery. Each treatment cycle is administered every 21-28 days and consists of chemotherapy (paclitaxel 175 mg/m², cisplatin 75-80 mg/m²) combined with camrelizumab (200 mg). Patients with 3 or more positive lymph nodes or para-aortic lymph node metastases receive 6 cycles of combined chemo-immunotherapy, whereas other patients receive 3 cycles. The primary outcome is 3-year disease-free survival rate. The secondary outcomes are overall survival rate, adverse events and health-related cancer-specific quality of life.
ClinicalTrials.gov identifier: NCT07167160.
This multicenter, prospective, single-arm phase II clinical trial is to evaluate the safety and preliminary efficacy of postoperative chemo-immunotherapy in cervical cancer patients with pathologically confirmed lymph node metastasis after radical hysterectomy, and to explore potential biomarkers associated with treatment response. Fifty-nine carefully selected cervical cancer patients with pathologically confirmed lymph node metastases and programmed death ligand-1 positivity (combined positive score ≥1) after radical surgery will be enrolled. Postoperative treatment is initiated 2-3 weeks after surgery. Each treatment cycle is administered every 21-28 days and consists of chemotherapy (paclitaxel 175 mg/m², cisplatin 75-80 mg/m²) combined with camrelizumab (200 mg). Patients with 3 or more positive lymph nodes or para-aortic lymph node metastases receive 6 cycles of combined chemo-immunotherapy, whereas other patients receive 3 cycles. The primary outcome is 3-year disease-free survival rate. The secondary outcomes are overall survival rate, adverse events and health-related cancer-specific quality of life.
ClinicalTrials.gov identifier: NCT07167160.