Actively Recruiting
Neoadjuvant Treatment of Neuroendocrine Cervix Carcinoma With Karelizumab Combined With Etoposide and Cisplatin
Led by Fujian Cancer Hospital · Updated on 2024-03-06
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of karelizumab combined with etoposide and cisplatin as a neoadjuvant treatment for neuroendocrine cervix carcinoma. This is an exploratory, single-arm Phase 2 clinical study focusing on patients with stage I-II cervical neuroendocrine carcinoma. The study aims to see how well this combination works before surgery and further treatment. Participants will receive treatment cycles where karelizumab is given first, followed by cisplatin and then etoposide, with at least 30 minutes between each drug. Patients who show complete or partial response will proceed to radical surgery and receive additional therapy afterward. Those with stable or progressive disease, or who are not suitable for surgery, will be treated with concurrent chemoradiotherapy. Throughout the study, participants will be monitored for tumor response using imaging to measure target lesions. The primary outcome is the objective response rate at 6 months. Secondary outcomes include progression-free survival, disease-free survival, overall survival rates at 1 and 3 years, disease control rates, and the incidence of adverse events over 5 years. Participants will undergo regular assessments of organ function, blood tests, and clinical evaluations to track safety and effectiveness during and after treatment.
CONDITIONS
Brief Title
Neoadjuvant Treatment of Neuroendocrine Cervix Carcinomar With Camrelizumab Combined With Etoposide and Cisplatin
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 75 years
- Diagnosis of cervical neuroendocrine carcinoma confirmed by histopathology or cytology with more than 60% neuroendocrine composition if mixed
- FIGO stage I or II disease suitable for surgery by an experienced gynecological oncologist
- At least one measurable tumor lesion with specific size criteria on CT scan
- ECOG performance status of 0 or 1
- Estimated postoperative survival time greater than 3 months
- Normal organ function meeting defined blood and biochemical test thresholds
- No participation in other clinical studies before or during this treatment
- Negative pregnancy test for women of childbearing age within 7 days before first treatment
- Agreement to contraception during treatment and for 24 weeks after last drug administration
- Ability and willingness to provide informed consent and comply with follow-up
You will not qualify if you...
- Previous chemotherapy, radiation, targeted therapy, or immunotherapy
- Contraindications to surgery or chemotherapy or poor physical condition preventing major abdominal surgery
- Presence of distant metastasis
- Active or history of autoimmune diseases except specific stable conditions
- History of immune deficiency or organ/bone marrow transplantation
- Severe heart, lung, liver, kidney diseases, neurological or mental illness
- Jaundice, gastrointestinal obstruction, or severe infections
- Pregnant or breastfeeding women
- Coronary heart disease grade I or above, arrhythmia, or cardiac dysfunction
- Abnormal coagulation function
- Poorly controlled cardiovascular symptoms or diseases
- History of interstitial lung disease or non-infectious pneumonia
- Allergy to karelizumab or any study medication components
- Considered unsuitable for inclusion 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 3-week cycles until surgery or treatment discontinuation
Participants receive neoadjuvant treatment with karelizumab combined with etoposide and cisplatin before surgery.
1 visit every 3 weeks for drug administration
Duration - Up to 1 week
Participants who respond to treatment undergo radical surgery.
1 surgical visit
Duration - Variable depending on treatment plan
Participants receive additional therapy based on their response and suitability for surgery.
Visit schedule varies based on therapy type
Duration - Up to 5 years
Participants are monitored for disease progression, survival, and adverse events after treatment completion.
Periodic visits for assessments over 5 years
Trial Site Locations
Total: 1 location
1
Fujian Cancer Hospital
Fuzhou, Fujian, China, 350014
Actively Recruiting
Research Team
H
He Hai Xin
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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