Cervical cancer
Conditions
Interventions
Experimental group:QL1706 and CCRT
Sponsors
Qilu Hospital of Shandong University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1)Female patients aged 18 to 75 years (inclusive). 2)Histologically confirmed cervical cancer, including squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma. 3)Disease staged according to the FIGO 2018 classification. 4)At least one evaluable lesion according to RECIST v1.1. 5)ECOG performance status of 0–1. 6)No prior curative-intent surgery, radiotherapy, or systemic therapy for cervical cancer, and no prior treatment with immune checkpoint inhibitors. Note: Prior surgical procedures for local cervical tumors are permitted. 7)Female participants must not be pregnant or breastfeeding. 8)Provision of written informed consent prior to study initiation.
Exclusion criteria
Exclusion criteria: 1)Histological subtypes including sarcoma, small cell carcinoma with neuroendocrine differentiation, or other non-epithelial malignancies. 2)History of severe (>= Grade 3) hypersensitivity reactions to Epalolizumab-Tovrilimab and/or any of its excipients. 3)Prior total hysterectomy, or planned total hysterectomy as part of initial treatment for cervical cancer. 4)Bilateral hydronephrosis, unless at least one side has been adequately managed by ureteral stenting or percutaneous nephrostomy. 5)Inability to receive intracavitary brachytherapy or a combined intracavitary and interstitial brachytherapy approach. 6)Pregnancy, breastfeeding, or intention to become pregnant during the expected study period. 7)Known additional malignancy that has progressed or required active treatment within the past 3 years. 8)Active autoimmune disease requiring systemic treatment (e.g., disease-modifying agents, corticosteroids, or immunosuppressive drugs) within the past 2 years; history of (non-infectious) pneumonitis requiring steroid treatment, or current pneumonitis. 9)Active infection requiring systemic therapy. 10)Any other condition that, in the investigator’s judgment, renders the patient unsuitable for participation in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 18-month progression-free survival rate;Objective response rate;Disease Control Rate;Progression-Free Survival;Safety and Tolerability; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival(OS); | — |
Countries
China
Contacts
Public ContactZhihua Wen
Qilu Hospital of Shandong University
Outcome results
None listed