Actively Recruiting
Phase II Study on Neoadjuvant Therapy of AK104 Combined With Nab-paclitaxel/Carboplatin in Fertility Preserving Surgery
Led by Xiaohua Wu · Updated on 2024-01-17
30
Participants Needed
1
Research Sites
278 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase II study of neoadjuvant therapy of AK104 combined with nab-paclitaxel/carboplatin in fertility saving surgery for stage IB2-IB3 cervical cancer (FIGO 2018). The main questions it aims to answer are: * · Evaluate the safety of AK104 combined with nab-paclitaxel/carboplatin in the neoadjuvant treatment of cervical cancer * · Evaluate the tumor regression and Major Pathological Response(MPR) of AK104 combined with nab-paclitaxel/carboplatin as neoadjuvant therapy for cervical cancer.
CONDITIONS
Official Title
Phase II Study on Neoadjuvant Therapy of AK104 Combined With Nab-paclitaxel/Carboplatin in Fertility Preserving Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign a written informed consent form.
- Female aged 18 to 45 years at enrollment.
- ECOG performance status score of 0 or 1.
- Histologically confirmed stage IB2-IB3 cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma.
- Imaging shows no distant or regional lymph node metastasis; tumor limited to cervix.
- No prior systemic or local anti-tumor treatment for cervical cancer before first medication.
- Desire to preserve reproductive function and medically suitable for fertility-sparing surgery.
- At least one untreated measurable lesion per RECIST v1.1.
- Agree to tumor tissue and blood sample collection during screening and study.
- Adequate organ function as defined by specific hematology, kidney, liver, coagulation, and heart function criteria.
- Negative pregnancy test within 3 days before first drug administration.
- Use of effective contraception from screening through 120 days after last dose if of childbearing potential.
- Willing and able to comply with study visits, treatment, and tests.
You will not qualify if you...
- Histopathological types of small cell carcinoma, gastric adenocarcinoma, or others not specified.
- Other malignant tumors within 3 years prior to enrollment, except certain cured localized cancers.
- Participation in another interventional clinical trial concurrently.
- Presence of distant metastasis or regional lymph node metastasis.
- Use of non-specific immunomodulatory therapy within specified time frames before first medication.
- Active autoimmune diseases requiring systemic treatment.
- History of non-infectious pneumonia requiring steroids or current interstitial lung disease.
- History of severe bleeding or coagulation disorders.
- Uncontrolled comorbid diseases or conditions affecting study participation or consent.
- Significant cardiovascular diseases or recent serious cardiac events.
- Recent gastrointestinal conditions such as ulcers, perforations, or bleeding.
- Recent thromboembolic events or acute exacerbation of COPD.
- Active or history of inflammatory bowel disease.
- Serious infections within 4 weeks or active infections treated within 10 days before first dose.
- Major surgery or serious trauma within 30 days before first medication.
- History of immunodeficiency, positive HIV test, or long-term immunosuppressant use.
- Active pulmonary tuberculosis or syphilis.
- History of allogeneic organ or stem cell transplantation.
- Untreated active hepatitis B or active hepatitis C.
- Receipt or planned receipt of live vaccines within 30 days before first dose.
- Hypersensitivity to study drug components or severe monoclonal antibody reactions.
- History of mental illness, substance abuse, alcoholism, or drug abuse.
- Pregnant or lactating women.
- Any condition that may interfere with study results or participant's full involvement.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
J
Jin Li
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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