Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
40 participants
INTERVENTIONAL
2024-09-12
2030-12-12
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Neoadjuvant Chemoimmunotherapy Versus Concurrent Chemoradiotherapy for LACC
NCT06288373
Neoadjuvant Chemotherapy Plus Camrelizumab for FIGO Stage IB1 Cervical Cancer
NCT06289062
Neoadjuvant Immunochemotherapy for Locally Advanced Cervical Cancer: a Prospective, Single-arm, Phase II Clinical Trial
NCT07003620
Neoadjuvant Chemotherapy Plus Cadonilimab for Locally Advanced Cervical Cancer
NCT07104149
Immunotherapy for Recurrent Cervical Cancer Refractory to Platinum-based Chemotherapy
NCT04188860
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Neoadjuvant chemotherapy plus camrelizumab (NACI)
Patients first received one cycle of platinum-based doublet priming chemotherapy. After 3 weeks, participants received two cycles of the PD-1 inhibitor camrelizumab combined with chemotherapy every 3 weeks. Patients with stable disease or progressive disease received concurrent chemoradiotherapy, and patients with a complete response or partial response proceeded to radical surgery.
Camrelizumab
200 mg, intravenously, 20-60 min. 2 times, every 21 days
Paclitaxel-albumin
260 mg/m² over 30 min, 3 times, every 21 days
Cisplatin
4 h, 75-80 mg/m², 3 times, every 21 days
radical surgery
Radical hysterectomy + pelvic lymphadenectomy 士 para-aortic lymphadenectomy
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Camrelizumab
200 mg, intravenously, 20-60 min. 2 times, every 21 days
Paclitaxel-albumin
260 mg/m² over 30 min, 3 times, every 21 days
Cisplatin
4 h, 75-80 mg/m², 3 times, every 21 days
radical surgery
Radical hysterectomy + pelvic lymphadenectomy 士 para-aortic lymphadenectomy
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Has at least one measurable lesion based on Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. In principle, the size of the lesion as shown by the magnetic resonance imaging examination is used as the criterion.
3. Histologically confirmed squamous carcinoma, adenocarcinoma (common type) or adenosquamous carcinoma of the cervix;
4. Negative PD-L1 expression on preoperative pathological examination (Combined positive score \< 1);
5. 18-70 years of age;
6. Eastern Cooperative Oncology Group score ≤ 1;
7. WBC≥3.5\*10\^9/L, NEU≥1.5\*10\^9/L, Platelet≥100×10\^9 /L; AST and ALT ≤1.5 times normal upper limit; Total bilirubin ≤1.5 times the upper limit of normal value; serum creatinine and blood urea nitrogen ≤the upper limit of normal value;
8. Well-compliance and willing to keep in touch;
9. Willing to participate in this study, sign the informed consent, and comply with the requirements and limitations outlined in the Informed Consent Form (ICF) and this form.
Exclusion Criteria
2. Prior treatment with immune checkpoint inhibitors, including, but not limited to, other anti-PD-1, anti-PD-L1 antibodies, CTLA-4 antibodies, or antibodies against immune co-stimulators (e.g., antibodies against ICOS, CD40, CD137, GITR, OX40 targets, etc.), or any other therapy targeting a tumor's immune mechanism of action;
3. Known hypersensitivity to any component and/or any excipient of the trial prescribed medication;
4. Immunosuppressive drugs or systemic corticosteroids for immunosuppression (\> mg/day of prednisone or other equivalent) within 2 weeks prior to trial dosing; topical, ophthalmic, intra-articular, intranasal, and inhaled corticosteroids are permitted;
5. Received herbs with antitumor effects or drugs with immunomodulatory effects (e.g., thymidine, interferon, interleukin-2) within 2 weeks prior to the trial;
6. Active systemic infection requiring systemic treatment;
7. Serious infection within 4 weeks prior to the first dose, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia;
8. Patients with untreated chronic hepatitis B, or HBV carriers with chronic hepatitis B virus (HBV) DNA greater than 1,000 IU/mL, or patients with active hepatitis C. Inactive HBsAg carriers, patients with hepatitis B who have received treatment and are in stable condition (HBV \< 1000 IU/mL), and patients with cured hepatitis C are eligible for enrollment. HCV antibody-positive subjects will be eligible for the study only if they have a negative HCV RNA test;
9. Known active tuberculosis (TB), patients with suspected active TB should undergo chest X-ray and sputum examination in conjunction with clinical signs and symptoms for exclusion;
10. Immunodeficiency or human immunodeficiency virus (HIV antibody positive);
11. Subjects with active inflammatory bowel disease or a history of such disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea). Subjects who are unable to swallow or who have malabsorption syndrome, uncontrolled nausea, vomiting, diarrhea, or other gastrointestinal disorders that severely interfere with drug intake and absorption;
12. Known interstitial lung disease that is symptomatic or may interfere with detection or treatment of immune-associated pneumonia;
13. Treatment with a live or attenuated vaccine administered within 4 weeks prior to the first trial dose, inactivated seasonal influenza virus vaccine is permitted;
14. Have received a prior allogeneic bone marrow transplant or solid organ transplant;
15. History of primary malignant tumor within the last 5 years;
16. Have undergone major surgery (e.g., open abdomen, open chest, organ resection, etc.) and severe trauma within 28 days prior to the first dose of the implantable infusion device is permitted;
17. With a history of gastrointestinal perforation, gastrointestinal fistula, or female genital fistula;
18. Uncontrolled other co-morbidities, symptoms, or medical history, including (i) persons with one of the following cardiovascular diseases or cardiovascular risk factors: myocardial infarction, unstable angina, pulmonary embolism, acute/continuous myocardial ischemia, cerebral vascular accident, transient ischemic attack, or other arterial or venous thrombosis, embolism, or cerebral ischemic event of clinical significance/requiring pharmacologic intervention; and persons who have had, within 6 months, a symptoms of congestive heart failure (New York Heart Association (NYHA) class III and above); (ii) clinically significant bleeding symptoms or a history of significant bleeding characteristics such as gastrointestinal bleeding, gastric ulcer bleeding, or vasculitis within 1 month prior to the first dose; (iii) clinically active hemoptysis, active diverticulitis, abdominal abscesses, and gastrointestinal obstruction; and (iv) uncontrolled pleural effusion, pericardial effusion, or ascites requiring Repeated drainage of ascites; ⑤ Abnormal liver or kidney development or history of surgery;
19. Pregnant or breastfeeding female patients; women of childbearing age who refuse to accept contraceptive measures during neoadjuvant immunotherapy;
20. Concurrent participation in other interventional clinical trials; participation in observational and non-interventional clinical trials is permitted;
21. Any condition that, in the judgment of the investigator, may result in risk in the receipt of the study drug or that would interfere with the evaluation of the safety of the study drug or the interpretation of the study results. Patients who, in the judgment of the Investigator, are unlikely to comply with the study steps, restrictions, and requirements are not permitted to participate in this study.
18 Years
70 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Southwest Hospital, China
OTHER
Women's Hospital School Of Medicine Zhejiang University
OTHER
Anhui Provincial Cancer Hospital
OTHER
Sichuan Cancer Hospital and Research Institute
OTHER
Gansu Provincial Maternal and Child Health Care Hospital
OTHER
Beijing Friendship Hospital
OTHER
Tianjin Medical University General Hospital
OTHER
Xiangya Hospital of Central South University
OTHER
West China Second University Hospital
OTHER
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Zhejiang Cancer Hospital
OTHER
Shengjing Hospital
OTHER
Qilu Hospital of Shandong University
OTHER
Cancer Hospital of Guangxi Medical University
OTHER
Tongji Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Kezhen Li
Prof
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ding Ma
Role: STUDY_CHAIR
Tongji Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Anhui Provincial Cancer Hospital
Hefei, Anhui, China
Beiing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
The First Affiliated Hospital (Southwest Hospital), Army Medical University (Third Military Medical University)
Chongqing, Chongqing Municipality, China
Gansu Provincial Maternity and Child-care Hospital
Lanzhou, Gansu, China
The Affiliated Tumor Hospital of Guangxi Medical University
Nanning, Guangxi, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Xiangya Hospital, Central South University
Changsha, Hunan, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Second People's Hospital of Sichuan (Sichuan Cancer Hospital)
Chengdu, Sichuan, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Women's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital, Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences
Hangzhou, Zhejiang, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Yun Dang, PhD
Role: primary
Ying Long, PhD
Role: primary
Dengfeng Wang, PhD
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MA-CervC-II-007
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
[2024](S019)
Identifier Type: OTHER
Identifier Source: secondary_id
NACI-CERV-002
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.