Actively Recruiting
RC48 Combined With Tislelizumab for Second-line Treatment of HER2 Expression in Recurrent Cervical Cancer
Led by Peking Union Medical College Hospital · Updated on 2023-10-02
30
Participants Needed
1
Research Sites
154 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
There is currently no standardized treatment for patients who have undergone first-line standard treatment. In this study, We investigated the efficacy and safty of RC48 combined with Tislelizumab in the second-line treatment of patients with HER2 expression in recurrent cervical cancer.
CONDITIONS
Official Title
RC48 Combined With Tislelizumab for Second-line Treatment of HER2 Expression in Recurrent Cervical Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female subjects aged 18 to 75 years old
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
- Life expectancy of at least 6 months as judged by the investigator
- Histologically or cytologically confirmed primary cervical squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma, or small cell (neuroendocrine) cervical cancer
- Measurable disease assessable by RECIST v1.1
- Adequate blood, liver, and kidney function as defined by the protocol
- Pathologically diagnosed HER2 expression (IHC 3+, 2+, or 1+) advanced cervical cancer, including prior test results confirmed by the investigator
- Negative blood pregnancy test for women of childbearing potential
- Use of highly effective contraception if there is a risk of pregnancy
You will not qualify if you...
- History of malignant tumors other than cervical cancer unless disease-free for 5 years after curative treatment or successful resection of certain skin or carcinoma in situ cancers
- Malignant disease other than cervical cancer within the last 5 years, excluding certain skin or carcinoma in situ cancers
- Previous stem cell allogeneic or organ transplant
- Anti-tumor systemic therapy less than 4 weeks before study or unresolved adverse events higher than grade 1 (except alopecia and pigmentation)
- Live vaccine received within 4 weeks before study dosing or planned vaccines (except COVID-19 vaccine) during study
- Previous or current congenital or acquired immunodeficiency
- Prior treatment with antibody-coupled drugs
- Not recovered from surgery or serious postoperative complications
- Known or suspected allergy to the study drug
- Heart failure classified as New York Heart Association (NYHA) grade 3 or above
- Severe active or poorly controlled infections including HIV, hepatitis B or C, tuberculosis, or other uncontrolled infections
- Other significant clinical or laboratory abnormalities affecting safety such as uncontrolled diabetes, chronic kidney disease, grade II or higher peripheral neuropathy, thyroid dysfunction
- Other conditions deemed unsuitable by the researchers
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
L
Lei Li, PhD
CONTACT
X
Xiao Shang, PhD
CONTACT
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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