Actively Recruiting
Exploratory Study on the Safety and Efficacy of Disitamab Vedotin in Combination with Anlotinib Hydrochloride for HER-2-expressing Recurrent Platinum-resistant Ovarian Cancer
Led by Second Xiangya Hospital of Central South University · Updated on 2024-10-28
5
Participants Needed
1
Research Sites
6 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Ovarian cancer is a serious disease affecting the female reproductive system, with many patients experiencing recurrence despite surgery and chemotherapy. This trial focuses on patients with recurrent platinum-resistant ovarian cancer (PROC), a group with poor prognosis and limited treatment options. Researchers are studying a combination of two drugs, Disitamab Vedotin (RC48), a HER2-targeted antibody drug, and Anlotinib, an oral anti-angiogenic agent, to explore their safety and effectiveness in treating this condition. Participants will receive Disitamab Vedotin intravenously at a dose of 2.0 mg/kg every two weeks, along with Anlotinib capsules taken orally at 10 mg daily for two weeks followed by a one-week break, repeating every 21 days. This combination therapy aims to improve response rates and quality of life by targeting HER2-expressing tumors with different mechanisms and manageable side effects. Throughout the study, participants will undergo regular assessments including tumor measurements based on RECIST 1.1 criteria, survival tracking, and monitoring of side effects for up to two years. Researchers will evaluate objective response rate (ORR) as the primary outcome, along with progression-free survival, overall survival, disease control rate, and duration of response. This careful monitoring will help understand the treatment's impact on tumor control and patient well-being.
CONDITIONS
Brief Title
Exploratory Study on the Safety and Efficacy of Disitamab Vedotin in Combination with Anlotinib Hydrochloride for the Treatment of HER-2-expressing Recurrent Platinum-resistant Ovarian Cancer.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must voluntarily join and sign informed consent with good compliance
- Age 18 years or older
- Diagnosed with epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer by pathology
- Provide tumor tissue samples showing HER2 expression (IHC 1+, 2+, or 3+)
- ECOG performance status of 0 or 1
- Expected survival longer than 12 weeks
- Adequate heart, bone marrow, liver, and kidney function
- At least one measurable lesion based on RECIST 1.1 criteria
- Women of childbearing potential must be surgically sterile, menopausal for at least one year, or agree to use effective contraception during the study
- Negative pregnancy test before first medication and non-lactating
You will not qualify if you...
- Previous treatment with HER2 antibody drug conjugates or similar anti-angiogenic drugs like anlotinib
- Primary platinum refractory disease
- Untreated or active central nervous system metastases, including brain or leptomeningeal metastases
- Symptoms or signs of intestinal obstruction requiring parenteral nutrition
- Recent bleeding events or conditions increasing bleeding risk, including unhealed wounds or ulcers
- Arterial or venous thrombosis within 6 months prior to study start
- Serious cardiovascular or cerebrovascular disease such as heart failure, uncontrolled arrhythmia, angina, or poorly controlled hypertension
- Unresolved toxicities from prior anti-tumor treatments above mild levels
- Major surgery within 4 weeks before starting medication or planned surgery
- Other malignant tumors within 3 years except certain adequately treated cancers
- Tumor invading major blood vessels with risk of fatal bleeding
- Requiring repeated drainage for pleural, pericardial effusion, or ascites
- Known allergies to study drugs
- Pregnant or breastfeeding women
- Serious comorbidities or conditions deemed unsuitable by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until disease progression or discontinuation
Participants receive Disitamab Vedotin intravenously every 2 weeks and take Anlotinib Hydrochloride capsules orally daily for 2 weeks followed by 1 week off, repeated in 21-day cycles.
Visits every 2 weeks for Disitamab Vedotin infusion and weekly visits for monitoring
Duration - Up to 2 years after treatment ends
Participants are monitored for up to 2 years after treatment for response and survival outcomes.
Periodic visits for assessment of tumor response and survival
Trial Site Locations
Total: 1 location
1
Xiangya Second Hospital of Central South University
Changsha, Hunan, China
Actively Recruiting
Research Team
J
jingjing Wang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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