The Efficacy and Safety RC48 Plus QL1706 in Second-Line Treatment of HER2-Expressing Recurrent CC
Clinical Study on the Efficacy and Safety of Disitamab Vedotin Combined With Iparomlimab and Tuvonralimab in the Second-Line Treatment of HER2-Expressing Recurrent Cervical Cancer
Sponsor: Qilu Hospital of Shandong University
No open prediction endpoints
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Primary Endpoints (CT.gov)
Objective Response Rate (ORR)
Time frame: 6 months after the last subject participating in
Secondary Endpoints
Progression-Free Survival
disease control rate (DCR)
duration of response (DOR)
Eligibility Criteria
Inclusion Criteria: * 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; * Subjects can provide tumor specimens (paraffin blocks, formalin-fixed paraffin-embedded \[FFPE\] sections, or fresh tissue sections) from the primary or metastatic site for HER2 detection, with HER2 immunohistochemistry (IHC) test results of IHC 1+, 2+, or 3+ (previous test results confirmed by the investigator are also acceptable); * Presence of at least one evaluable lesion (per RECIST 1.1 criteria); * Expected survival time ≥ 6 months; * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 to 1; * For female patients of childbearing potentia…
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