Actively Recruiting
Neoadjuvant Chemoimmunotherapy Versus Concurrent Chemoradiotherapy for LACC
Led by Tongji Hospital · Updated on 2024-10-30
440
Participants Needed
12
Research Sites
357 weeks
Total Duration
On this page
Sponsors
T
Tongji Hospital
Lead Sponsor
S
Southwest Hospital, China
Collaborating Sponsor
AI-Summary
What this Trial Is About
It is a prospective, open-label, randomized, controlled phase II/III clinical trial in which patients with PD-L1-positive FIGO stage IB3, IIA2 and IIB（tumors \>4 cm in diameter）will be enrolled and randomly divided into the neoadjuvant chemoimmunotherapy plus surgery group and the CCRT group.
CONDITIONS
Official Title
Neoadjuvant Chemoimmunotherapy Versus Concurrent Chemoradiotherapy for LACC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 70 years
- Diagnosed with locally advanced cervical cancer (FIGO stage IB3, IIA2, or IIB) with tumor size greater than 4 cm
- At least one measurable lesion at baseline according to RECIST 1.1 criteria assessed by MRI
- Pathologically confirmed cervical squamous cell carcinoma, adenocarcinoma (common type), or adenosquamous carcinoma
- Positive PD-L1 expression with Combined Positive Score (CPS) of 1 or higher
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Laboratory test results within specified limits: WBC ≥ 3.5×10⁹/L, neutrophils ≥ 1.5×10⁹/L, platelets ≥ 100×10⁹/L, total bilirubin ≤ 1.5 times upper normal limit, ALT and AST ≤ 1.5 times upper normal limit, serum creatinine or creatinine clearance within defined thresholds
- Willing to comply with follow-up and study procedures
- Signed informed consent and agreement to study requirements
- Agree to use effective contraception during the trial and for 5 months after last pembrolizumab dose or 6 months after chemotherapy (whichever is longer)
You will not qualify if you...
- Active autoimmune disease or history of autoimmune disease requiring systemic treatment
- Previous treatment with immune checkpoint inhibitors or hypersensitivity to study drugs
- History of HIV infection or active hepatitis B or C infections
- Use of immunosuppressive drugs or systemic corticosteroids within 2 weeks before study dosing
- Diagnosis of another primary cancer within 5 years before study drug use
- Participation in other investigational drug trials within 4 weeks before randomization
- Pregnant or breastfeeding women
- Uncontrolled serious heart, vascular, neurological, blood, liver, or kidney conditions
- Recent active infection requiring systemic treatment within 14 days before first dose
- Live or attenuated vaccine within 4 weeks before first dose (except seasonal flu vaccine)
- History of allogeneic bone marrow or solid organ transplant
- Drug or alcohol abuse
- Investigator judgment that patient may not comply with study requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
Anhui Provincial Cancer Hospital
Hefei, Anhui, China, 230000
Actively Recruiting
2
Beiing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Actively Recruiting
3
The First Affiliated Hospital (Southwest Hospital), Army Medical University (Third Military Medical University)
Chongqing, Chongqing Municipality, China, 400038
Actively Recruiting
4
Gansu Provincial Maternity and Child-care Hospital
Lanzhou, Gansu, China, 730050
Actively Recruiting
5
The Affiliated Tumor Hospital of Guangxi Medical University
Nanning, Guangxi, China, 530021
Actively Recruiting
6
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Actively Recruiting
7
Xiangya Hospital, Central South University
Changsha, Hunan, China, 410008
Actively Recruiting
8
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Actively Recruiting
9
Second People's Hospital of Sichuan (Sichuan Cancer Hospital)
Chengdu, Sichuan, China, 610041
Actively Recruiting
10
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
11
Women's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
12
Zhejiang Cancer Hospital, Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
Research Team
K
Kezhen Li
CONTACT
J
Jing Chen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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