Actively Recruiting
Neoadjuvant Chemoimmunotherapy and Extrafascial Hysterectomy for IB2 Cervical Cancer
Led by Tongji Hospital · Updated on 2024-09-19
50
Participants Needed
2
Research Sites
330 weeks
Total Duration
On this page
Sponsors
T
Tongji Hospital
Lead Sponsor
T
The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is an exploratory clinical trial to investigate the feasibility of neoadjuvant chemoimmunotherapy plus extrafascial hysterectomy and pelvic lymph node dissection in patients with stage IB2 (2018 FIGO) cervical cancer and to observe the response rate to treatment, adverse effects and complications, and to assess the survival rate of patients.
CONDITIONS
Official Title
Neoadjuvant Chemoimmunotherapy and Extrafascial Hysterectomy for IB2 Cervical Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of untreated stage IB2 cervical cancer confirmed by imaging and gynecologic examination
- At least one measurable tumor lesion based on MRI using RECIST 1.1 criteria
- Pathologically confirmed cervical cancer: squamous cell carcinoma (any grade), usual type adenocarcinoma (G1 or G2 / Silva A or B), or adenosquamous carcinoma (G1 or G2)
- Positive PD-L1 expression with Combined Positive Score (CPS) of 1 or more
- Female patients aged 18 to 70 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Laboratory tests showing adequate blood counts and organ function within specified limits
- Willingness to comply with study follow-up and procedures
- Ability and willingness to sign informed consent
You will not qualify if you...
- Active, known, or suspected autoimmune disease requiring systemic therapy, except specified controlled conditions
- Prior treatment with immune checkpoint inhibitors or other immunotherapies targeting tumor immune mechanisms
- Known allergy to study medications or their components
- Use of immunosuppressive drugs or systemic corticosteroids above specified doses within 2 weeks before treatment
- Use of herbs or drugs with immunomodulatory effects within 2 weeks before treatment
- Active systemic infection or serious infection requiring hospitalization within 4 weeks before treatment
- Untreated or active hepatitis B or C infection not meeting stability criteria
- Known active tuberculosis or suspected active tuberculosis
- Immunodeficiency or HIV positive status
- Active inflammatory bowel disease or related gastrointestinal disorders that interfere with drug intake
- Symptomatic interstitial lung disease or conditions that may interfere with pneumonia detection or treatment
- Live or attenuated vaccine administration within 4 weeks before treatment (except inactivated influenza vaccine)
- History of allogeneic bone marrow or solid organ transplant
- History of primary malignant tumor within the last 5 years
- Major surgery or severe trauma within 28 days before treatment
- History of gastrointestinal or female genital fistula
- Uncontrolled cardiovascular disease, bleeding disorders, or other significant comorbidities
- Pregnant or breastfeeding women or women not agreeing to contraception during treatment
- Participation in other interventional clinical trials
- Any condition judged by the investigator to pose excessive risk or interfere with study evaluation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Actively Recruiting
2
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012
Actively Recruiting
Research Team
G
Gang Chen
CONTACT
J
Jing Chen
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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