Actively Recruiting
Neoadjuvant Chemotherapy Plus Camrelizumab in PD-L1-negative Locally Advanced Cervical Cancer: a Multicentre, Single-arm, Phase 2 Trial
Led by Tongji Hospital · Updated on 2025-03-20
40
Participants Needed
12
Research Sites
258 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
Researchers are evaluating the combination of neoadjuvant chemotherapy and the PD-1 inhibitor camrelizumab (NACI) for women with PD-L1-negative locally advanced cervical cancer. This phase 2, multicenter, single-arm trial aims to assess the treatment's impact on tumor remission, surgical complications, positive margin rates, and survival. The study also explores changes in immune factors and tumor cells during treatment and seeks biomarkers that may affect therapy effectiveness. Participants first receive one cycle of platinum-based doublet priming chemotherapy. After three weeks, they receive two cycles of camrelizumab combined with chemotherapy every 21 days. Those with stable or progressive disease proceed to concurrent chemoradiotherapy, while patients showing complete or partial response undergo radical surgery including hysterectomy and lymphadenectomy. Throughout the study, participants undergo evaluations of tumor response, surgery outcomes, and survival for up to seven years. Researchers monitor pathologic complete response after surgery and track surgical complications, objective response rates, positive margin rates, and patient-reported outcomes. Safety and adverse events are assessed over long-term follow-up, with adherence and willingness to comply being key participation factors.
CONDITIONS
Brief Title
Neoadjuvant Immunochemotherapy in PD-L1-negative LACC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 70 years
- Diagnosed with FIGO 2018 stage IB3, IIA2, or IIB/IIIC1r cervical cancer with tumor size greater than 4 cm
- Have at least one measurable lesion per RECIST version 1.1 criteria
- Histologically confirmed squamous carcinoma, adenocarcinoma (common type), or adenosquamous carcinoma of the cervix
- Negative PD-L1 expression on preoperative pathology (combined positive score less than 1)
- Eastern Cooperative Oncology Group score of 0 or 1
- Adequate blood counts and organ function as specified
- Willing and able to comply with study procedures and provide informed consent
You will not qualify if you...
- Active or history of autoimmune disease except certain controlled conditions
- Prior treatment with immune checkpoint inhibitors or therapies targeting tumor immune mechanisms
- Known hypersensitivity to study drugs or excipients
- Use of immunosuppressive drugs or systemic corticosteroids within 2 weeks before dosing
- Use of herbs or drugs with immunomodulatory effects within 2 weeks before dosing
- Active systemic infection or serious recent infection
- Untreated or active hepatitis B or C, or active tuberculosis
- Immunodeficiency or HIV positive
- Active inflammatory bowel disease or severe gastrointestinal disorders
- Symptomatic interstitial lung disease
- Recent live or attenuated vaccine administration within 4 weeks
- Prior allogeneic bone marrow or solid organ transplant
- History of primary malignant tumor within last 5 years
- Recent major surgery or severe trauma within 28 days
- History of gastrointestinal or female genital fistula
- Uncontrolled co-morbidities including significant cardiovascular disease or bleeding disorders
- Pregnant or breastfeeding, or unwilling to use contraception during treatment
- Concurrent participation in other interventional clinical trials
- Any condition posing risk or interfering with study participation as judged by investigator
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.
screening and enrollment visit
Duration - Approximately 9 weeks
Participants receive one cycle of platinum-based doublet priming chemotherapy, followed by two cycles of camrelizumab combined with chemotherapy every 3 weeks.
3 treatment visits every 3 weeks
Duration - 1 day
Participants who respond to treatment proceed to radical surgery including radical hysterectomy and lymphadenectomy.
1 surgical visit (in-person)
Duration - Up to 7 years
Participants are monitored for surgical complications, treatment response, survival, and adverse events over several years.
Regular follow-up visits over 7 years
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
J
Jie Yang
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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