This is a single-arm study. The efficacy and safety of Disitamab Vedotin combined with Apalutamide and Toripalimab in the second-line treatment of HER2-expressing recurrent cervical cancer are evaluated based on the following indicators:
Primary evaluation indicator: Objective Response Rate (ORR)
Secondary evaluation indicators:
Efficacy-related indicators: Progression-Free Survival (PFS), Disease Control Rate (DCR), Duration of Response (DOR), Overall Survival (including median Overall Survival \[mOS\] and 1-year, 2-year, 3-year Overall Survival rates) Safety-related indicators: Adverse Events (AEs) and Serious Adverse Events (SAEs).
Voluntarily enroll in the study and sign a written informed consent form;
Female patients aged 18 to 75 years (inclusive);
Histologically or cytologically confirmed primary cervical squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma, or small cell (neuroendocrine) cervical cancer;
Progressive disease or recurrent disease after first-line treatment for recurrent cervical cancer;
Patients who have received potentially curative treatment and have no evidence of the disease for 5 years;
Basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, cervical carcinoma in situ, and other carcinoma in situ that have been successfully treated with resection;
Previous allogeneic stem cell or solid organ transplantation;
Previous systemic anti-tumor therapy (including traditional Chinese medicine with anti-tumor indications) completed less than 4 weeks before the first administration of the study drug, or patients whose adverse events caused by previous treatment have not recovered to ≤ Grade 1 according to the Common Terminology Criteria for Adverse Events (CTCAE) (except for alopecia and pigmentation);
Single group
RC48
DrugDisitamab Vedotin (RC48) : 2.5 mg/kg, administered once every 3 weeks (Q3w), via intravenous infusion on Day 1 of each treatment cycle
QL1706
DrugDrug: QL1706 Iparomlimab and Tuvonralimab (QL1706) : 5 mg/kg in total, administered once every 3 weeks (Q3w), via intravenous infusion on Day 1 of each treatment cycle
Objective Response Rate (ORR)
The proportion of subjects with complete response (CR) and partial response (PR) according RESIST 1.1 in total subjects.
Progression-Free Survival
The time elapsed from the enrollment date to the first occurrence of either tumor progression or death from any cause.
disease control rate (DCR)
The proportion of subjects with complete response (CR) and partial response (PR) and stable disease(SD) in total subjects
duration of response (DOR)
The time from the date for first documented response of complete response (CR) or partial response (PR) to the date of first documented of disease progression or death, whichever occurs first.
overall survival (OS)
The time from the starting date of study drug to the date of death due to any cause.
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