Actively Recruiting
Neoadjuvant Immunochemotherapy in PD-L1-negative LACC
Led by Tongji Hospital · Updated on 2025-03-20
40
Participants Needed
12
Research Sites
326 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
This is a multicenter, prospective, single-arm, phase 2 clinical trial designed to evaluate the therapeutic efficacy of the NACI (neoadjuvant chemotherapy plus Camrelizumab) for PD-L1-negative locally advanced cervical cancer.
CONDITIONS
Official Title
Neoadjuvant Immunochemotherapy in PD-L1-negative LACC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 70 years
- Diagnosed with FIGO 2018 stage IB3, IIA2, or IIB/IIIC1r cervical cancer with tumor size greater than 4 cm and no prior treatment
- At least one measurable lesion based on RECIST version 1.1 using MRI
- Histologically confirmed squamous carcinoma, common adenocarcinoma, or adenosquamous carcinoma of the cervix
- Negative PD-L1 expression (Combined positive score < 1) on preoperative pathology
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate blood counts and liver, kidney function within specified limits
- Able to comply with study requirements and willing to sign informed consent
You will not qualify if you...
- Active, known, or suspected autoimmune disease requiring systemic therapy within the last 2 years except specified stable conditions
- Prior treatment with immune checkpoint inhibitors or therapies targeting tumor immune mechanisms
- Known allergy to any study medication or excipients
- Use of immunosuppressive drugs or systemic corticosteroids above specified doses within 2 weeks before study
- Use of herbs or drugs with immunomodulatory effects within 2 weeks before study
- Active systemic infection or serious infections within 4 weeks before study
- Untreated or uncontrolled hepatitis B or C infection
- Known active tuberculosis or suspected active TB
- Immunodeficiency or HIV positive status
- Active inflammatory bowel disease or severe gastrointestinal disorders affecting drug intake
- Symptomatic interstitial lung disease
- Live or attenuated vaccine within 4 weeks prior to study dosing
- Prior allogeneic bone marrow or solid organ transplant
- History of primary malignant tumor within last 5 years
- Major surgery or severe trauma within 28 days before first dose
- History of gastrointestinal or female genital fistula or perforation
- Uncontrolled cardiovascular diseases, bleeding disorders, or other serious co-morbidities
- Pregnant or breastfeeding or unwilling to use contraception during treatment
- Concurrent participation in other interventional clinical trials
- Any condition that may increase risk or interfere with study evaluations as judged by investigator
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
Jie Yang
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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