This is a Randomized, Open-Label, Controlled, Multicenter Phase III Clinical Study to evaluate the efficacy of WX390 in combination with toripalimab versus investigator's choice of therapy in patients with recurrent or metastatic cervical cancer who have failed at least one prior platinum-based systemic therapy, as assessed by overall survival (OS).
The subject voluntarily participates in this clinical study, has provided signed informed consent prior to the initiation of any screening procedures, and is able to understand and comply with the study requirements.
Aged 18 to 75 years (inclusive, calculated on the day of signing the informed consent form).
Histologically or cytologically confirmed cervical cancer, including squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma.
Not eligible for curative treatment with surgery, radiotherapy, or chemoradiotherapy.
Previous treatment with any PI3K, AKT, or mTOR inhibitor, or prior treatment with toripalimab.
Patients with type 1 or type 2 diabetes mellitus.
History of interstitial lung disease, drug-induced pneumonitis, pulmonary fibrosis, pneumoconiosis, or radiation pneumonitis (patients with only radiographic evidence of radiation pneumonitis and not requiring corticosteroid therapy may be enrolled). Patients with active pneumonia during screening, severely impaired lung function, or other conditions that may interfere with the detection and management of suspected drug-related pulmonary toxicity.
Radiographic evidence of tumor invasion into the bladder or rectum, deemed by the investigator to pose a risk of perforation; or a known history of female reproductive tract fistula (e.g., vesicovaginal fistula, urethrovaginal fistula, cervicovesical fistula, etc.). Patients may be enrolled if the perforation or fistula has been treated with diversion surgery, resection, or repair, and the condition is considered resolved or controlled by the investigator.
Parallel
WX390 1.1mg + Toripalimab 240mg
DrugParticipants will receive WX390 continuous oral dosing (1.1 mg once a day) and Toripalimab fixed dose (240mg, intravenous, Day 1, every 3 weeks).
Investigator's Choice of Chemotherapy
DrugRandomization for these two strata will be closed upon reaching the total enrollment of 310 subjects who are immunotherapy-naïve or have tumors with PIK3CA wild-type status confirmed by the central laboratory.
Overall survival in cervical cancer patients who have failed at least one prior line of platinum-based therapy
Efficacy including ORR was assessed by both the investigator and a Blinded Independent Central Review committee according to RECIST v1.1 criteria.
Adverse Events (AEs), including type, incidence, grading (assessed according to the NCI-CTCAE v5.0 criteria), severity, and relationship to the investigational drug, among others.
Efficacy including DCR was assessed by both the investigator and a Blinded Independent Central Review committee according to RECIST v1.1 criteria.
Efficacy including DoR was assessed by both the investigator and a Blinded Independent Central Review committee according to RECIST v1.1 criteria.
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