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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
RC48+carboplatin±bevacizumab
DrugRC48 (2.5mg/kg iv on d1 , every 21d for 6 cycles) + Carboplatin (AUC5 iv on d1 every 21d for 6 cycles)±Bevacizumab (7.5-15mg/kg iv on d1 every 21d for 6 cycles) for treatment followed by RC48 (2.5mg/kg iv on d1 , every 21d for 8 cycles)±Bevacizumab (7.5-15mg/kg iv on d1 every 21d for progress ) maintenance therapy.
Treatment groups
54 Participants
are divided into 1 treatment groupGroup A: RC48+carboplatin±bevacizumabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Progression-Free Survival (PFS)
PFS is defined as time (in months) from date of randomization to the date of the first documentation of objective progressive disease (PD) or death due to any cause in the absence of documented PD (whichever occurs first). PFS will be determined according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) based on investigator response assessment.
Time frame
Up to approximately 2 yearsSecondary outcomes
1
Objective Response Rate（ORR）
ORR is defined as Investigator-assessed CR + PR, per RECIST 1.1
Time frame
Up to approximately 2 years2
Disease Control Rate (DCR)
DCR is defined as the percentage of cases with remission (PR+CR) and stable disease (SD) after treatment in the evaluable cases.
Time frame
Up to approximately 2 years3
Overall Survival（OS）
OS is defined as the time (in months) from randomization to the date of death, regardless of the actual cause of the subject's death.
Time frame
Up to approximately 2 years4
Number of Participants With Adverse Events (AEs)
Assessment of the toxicity profile of regimen according to the National Cancer Institute Common Toxicity Criteria version 5.0 (NCI CTCAE v 5.0).
Time frame
Up to approximately 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov