RC48 Treatment for Platinum Sensitive Recurrent Ovarian Cancer With HER2 Expression
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorPeking University Cancer Hospital & Institute
About this trial
The purpose of this study is to evaluate the efficacy, safety, and quality of life scores of patients with HER2-expressing platinum-sensitive recurrent epithelial ovarian cancer treated with the combination therapy regimen of RC48 plus platinum with or without bevacizumab.
Eligibility criteria
Qualifiers
Female subjects aged from 18 to 75 years old;
Pathology confirmed the diagnosis of primary epithelial ovarian/fallopian tube/peritoneal carcinoma;
Previous treatment lines ≥1 and ≤4, first-line treatment may include maintenance therapy after complete clinical or pathological response;Previously not receiving targeted HER2 drug therapy (including monoclonal antibodies and ADC drugs)
Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at trial entry;
Disqualifiers
The pathological type is non epithelial ovarian/fallopian tube/peritoneal cancer or metastatic ovarian cancer;
The patient has ≥ grade 2 peripheral neuropathy;
Patients with active bleeding or pathological conditions with high risk of bleeding, such as known hemorrhagic diseases, coagulation disorders, or tumors involving large blood vessels;
Suffering from central nervous system metastasis and/or cancerous meningitis. Except for stable brain metastases; 5.The toxicity caused by previous anti-tumor treatments has not yet recovered to CTCAE (version 5.0) level 0-1 (excluding 2nd degree hair loss);
Trial design
Treatments tested in this trial
- RC48+carboplatin±bevacizumab
Treatment groups
54 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov