Actively Recruiting
Neoadjuvant Chemoimmunotherapy Combined With Surgery Versus Concurrent Chemoradiotherapy for Locally Advanced Cervical Cancer: a Multicenter Randomized Controlled Clinical Trial
Led by Tongji Hospital · Updated on 2024-10-30
440
Participants Needed
12
Research Sites
N/A
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 investigating treatment options for locally advanced cervical cancer (LACC) in patients with PD-L1-positive tumors larger than 4 cm. This trial compares neoadjuvant chemoimmunotherapy followed by surgery against the current standard treatment of concurrent chemoradiotherapy (CCRT). The study aims to assess differences in clinical outcomes and side effects between these two approaches to provide better evidence for neoadjuvant immunotherapy use in cervical cancer. Participants will be randomly assigned to one of two groups. One group receives one cycle of cisplatin and nab paclitaxel chemotherapy combined with two cycles of camrelizumab before surgery. Patients who respond well will undergo radical hysterectomy and lymph node removal, while those with stable or progressing disease will receive CCRT. The other group will receive pelvic external beam radiation therapy plus weekly cisplatin chemotherapy and brachytherapy as standard care. Throughout the study, participants will be monitored with imaging to assess tumor response and will undergo various evaluations including physical exams, laboratory tests, and quality of life questionnaires. Researchers will track progression-free survival and objective response rate as primary outcomes, with additional measures such as overall survival, surgical complications, and treatment safety followed for up to seven years. The trial includes long-term follow-up to assess physical function and symptom changes over time.
CONDITIONS
Brief Title
Neoadjuvant Chemoimmunotherapy Versus Concurrent Chemoradiotherapy for LACC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with locally advanced cervical cancer (FIGO stage IB3, IIA2, or IIB) with tumor size greater than 4 cm
- At least one measurable tumor lesion based on MRI and RECIST 1.1 criteria
- Pathological confirmation of cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma
- Positive PD-L1 expression with Combined Positive Score (CPS) of 1 or higher
- Female patients aged 18 to 70 years
- ECOG performance status score of 0 or 1
- Adequate laboratory results including white blood cells, neutrophils, platelets, liver and kidney function within specified limits
- Willing to comply with follow-up and study requirements
- Willing to sign informed consent
- Agree to use effective contraception during the study and for specified months after treatment
You will not qualify if you...
- Active autoimmune disease or history requiring systemic treatment
- Prior treatment with immune checkpoint inhibitors or known allergy to study drugs
- History of HIV infection or active hepatitis B or C infection
- Use of immunosuppressive or systemic corticosteroid therapy within 2 weeks before dosing
- Diagnosis of another primary cancer within 5 years before study drug use
- Participation in other investigational drug trials within 4 weeks prior to randomization
- Pregnant or breastfeeding women
- Uncontrolled heart, brain, blood, or infectious conditions as specified
- Receipt of live or attenuated vaccines within 4 weeks prior to dosing
- Prior bone marrow or solid organ transplant
- Drug or alcohol abuse
- Any condition that might prevent compliance with study procedures or requirements
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 - Approximately 9 weeks (3 cycles, each 3 weeks)
Participants receive 1 cycle of cisplatin and nab paclitaxel chemotherapy followed by 2 cycles of camrelizumab combined neoadjuvant chemotherapy before surgery.
3 visits (in-person, every 3 weeks)
Duration - Single event
Participants who respond to chemotherapy undergo open radical hysterectomy and pelvic lymph node dissection.
1 visit (in-person, surgical procedure)
Duration - Approximately 5 weeks
Participants receive pelvic external beam radiation therapy combined with weekly cisplatin chemotherapy and brachytherapy according to standard care.
Weekly visits for 5 weeks
Duration - Up to 7 years
Participants are monitored for safety, disease progression, and quality of life after treatment.
Periodic visits as scheduled by the study
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
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3
The First Affiliated Hospital (Southwest Hospital), Army Medical University (Third Military Medical University)
Chongqing, Chongqing Municipality, China, 400038
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4
Gansu Provincial Maternity and Child-care Hospital
Lanzhou, Gansu, China, 730050
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5
The Affiliated Tumor Hospital of Guangxi Medical University
Nanning, Guangxi, China, 530021
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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
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8
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
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9
Second People's Hospital of Sichuan (Sichuan Cancer Hospital)
Chengdu, Sichuan, China, 610041
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10
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
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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
Jing Chen
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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