Gastric-type adenocarcinoma of the cervix is the most commonly diagnosed HPV-independent subtype of cervical cancer, characterized by a poor prognosis and limited responsiveness to existing therapies. Therefore, the exploration of new treatment modalities is critically important. This is an open-label, single-arm, multi-center clinical trial to evaluate the efficacy and safety of IN10018 plus nab-paclitaxel and cadonilimab in the treatment of adult women with metastatic, recurrent, or persistent gastric-type adenocarcinoma of the cervix.
Subjects will receive IN10018 at a dose of 100 mg orally once daily, in combination with nab-paclitaxel at 260 mg/m² and cadonilimab at 10 mg/kg, both administered via intravenous infusion on Day 1 of each 3-week cycle. Tumor assessments will be conducted every 2 cycles throughout the treatment period. If the therapy proves effective, chemotherapy will continue for up to 6 cycles. Upon completion of chemotherapy, maintenance therapy with cadonilimab and IN10018 will begin and continue until either disease progression or the emergence of intolerable toxicity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
100 mg, orally, once daily
260 mg/m², IV infusion, Q3W
10 mg/kg, IV infusion, Q3W
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGXiangyang Central Hospital
Xiangyang, Hubei, China
RECRUITINGObjective Response Rate (ORR)
ORR is defined as the percentage of the participants in the ITT population who have a complete response (CR) or partial response (PR). The ORR will be assessed by a blind independent central reviewer per RECIST 1.1
Time frame: Every 6 weeks from the time of the first dose of the study drug until the completion of treatment, lasting approximately 18 weeks.
Progression-free survival (PFS)
PFS is defined as the time from the first dose of study treatment/randomization to the first documentation of disease progression or death due to any cause, whichever comes first
Time frame: 2 years
Disease Control Rate (DCR)
DCR is defined as the proportion of patients who achieve complete response (CR), partial response (PR), or stable disease (SD) following treatment. The DCR will be assessed by a blind independent central reviewer per RECIST 1.1
Time frame: Every 6 weeks from the time of the first dose of the study drug until the completion of treatment, lasting approximately 18 weeks.
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