To hear about similar clinical trials, please enter your email below

Trial Title: Neoadjuvant Immunochemotherapy in PD-L1-negative LACC

NCT ID: NCT06288360

Condition: Cervical Cancer
Locally Advanced Cervical Cancer
PD-L1 Negative
Neoadjuvant Chemoimmunotherapy

Conditions: Official terms:
Uterine Cervical Neoplasms
Paclitaxel
Albumin-Bound Paclitaxel
Cisplatin

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Camrelizumab
Description: 200 mg, intravenously, 20-60 min. 2 times, every 21 days
Arm group label: Neoadjuvant chemotherapy plus camrelizumab (NACI)

Other name: SHR-1210

Intervention type: Drug
Intervention name: Paclitaxel-albumin
Description: 260 mg/m² over 30 min, 3 times, every 21 days
Arm group label: Neoadjuvant chemotherapy plus camrelizumab (NACI)

Other name: Injectable paclitaxel (albumin bound)

Intervention type: Drug
Intervention name: Cisplatin
Description: 4 h, 75-80 mg/m², 3 times, every 21 days
Arm group label: Neoadjuvant chemotherapy plus camrelizumab (NACI)

Other name: Cisplatin injection

Intervention type: Procedure
Intervention name: radical surgery
Description: Radical hysterectomy + pelvic lymphadenectomy 士 para-aortic lymphadenectomy
Arm group label: Neoadjuvant chemotherapy plus camrelizumab (NACI)

Summary: 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.

Detailed description: This multicenter, prospective, single-arm clinical trial is designed to enroll patients with PD-L1-negative, locally advanced cervical cancer. Patients will receive an initial course of priming neoadjuvant chemotherapy, followed by two courses of neoadjuvant immunochemotherapy. The study aims to evaluate the effects of combining neoadjuvant chemotherapy with a PD-1 inhibitor on tumor remission rates, surgical complications, positive margin rates, and patient survival. Additionally, the trial will investigate changes in local immune-related factors and tumor cells during treatment, as well as identify biomarkers that may influence the efficacy of neoadjuvant immunochemotherapy.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. FIGO 2018 stage IB3, IIA2, or IIB/IIIC1r (tumor size≥4cm) cervical cancer and without any treatment (After undergoing gynecological examinations by two associate chief physicians or above, the staging of the patients was determined); 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: 1. Active, known, or suspected autoimmune disease, or a history of an autoimmune disease, except for the following: vitiligo, alopecia areata, Graves's disease, psoriasis, or eczema that has not required systemic therapy within the last 2 years, hypothyroidism that is asymptomatic or requires only stable doses of hormone replacement therapy (due to autoimmune thyroiditis), type 1 diabetes that requires only stable doses of insulin replacement therapy, asthma that subsides completely in childhood and does not require intervention in adulthood, or diseases that do not recur in the absence of external triggers; 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.

Gender: Female

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Locations:

Facility:
Name: Anhui Provincial Cancer Hospital

Address:
City: Hefei
Zip: 230000
Country: China

Status: Recruiting

Contact:
Last name: Bairong Xia, PhD
Email: xiabairong@ustc.edu.cn

Investigator:
Last name: Bairong Bairong, PhD
Email: Principal Investigator

Facility:
Name: Beiing Friendship Hospital, Capital Medical University

Address:
City: Beijing
Country: China

Status: Recruiting

Contact:
Last name: Zhiqi Wang, PhD
Email: wangzqnet@sina.com

Investigator:
Last name: Zhiqi Wang, PhD
Email: Principal Investigator

Facility:
Name: The First Affiliated Hospital (Southwest Hospital), Army Medical University (Third Military Medical University)

Address:
City: Chongqing
Zip: 400038
Country: China

Status: Recruiting

Contact:
Last name: Yanzhou Wang, PhD
Email: w.y.z@foxmail.com

Investigator:
Last name: Yanzhou Wang, PhD
Email: Principal Investigator

Facility:
Name: Gansu Provincial Maternity and Child-care Hospital

Address:
City: Lanzhou
Zip: 730050
Country: China

Status: Recruiting

Contact:
Last name: Yun Dang, PhD

Investigator:
Last name: Yun Dang, PhD
Email: Principal Investigator

Facility:
Name: The Affiliated Tumor Hospital of Guangxi Medical University

Address:
City: Nanning
Zip: 530021
Country: China

Status: Recruiting

Contact:
Last name: Ying Long, PhD

Investigator:
Last name: Ying Long, PhD
Email: Principal Investigator

Facility:
Name: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Address:
City: Wuhan
Zip: 430030
Country: China

Status: Recruiting

Contact:
Last name: Jing Chen

Phone: 086-027-8362
Email: chenjing3223@126.com

Investigator:
Last name: Kezhen Li
Email: Principal Investigator

Investigator:
Last name: Gang Chen
Email: Principal Investigator

Facility:
Name: Xiangya Hospital, Central South University

Address:
City: Changsha
Zip: 410008
Country: China

Status: Recruiting

Contact:
Last name: Yu Zhang, PhD
Email: xyzhangyu@csu.edu.cn

Investigator:
Last name: Yu Zhang, PhD
Email: Principal Investigator

Facility:
Name: Shengjing Hospital of China Medical University

Address:
City: Shenyang
Country: China

Status: Recruiting

Contact:
Last name: Tingting Gong, PhD
Email: gongtt@sj-hospital.org

Investigator:
Last name: Tingting Gong
Email: Principal Investigator

Facility:
Name: Second People's Hospital of Sichuan (Sichuan Cancer Hospital)

Address:
City: Chengdu
Zip: 610041
Country: China

Status: Recruiting

Contact:
Last name: Dengfeng Wang, PhD

Investigator:
Last name: Dengfeng Wang, PhD
Email: Principal Investigator

Facility:
Name: Tianjin Medical University General Hospital

Address:
City: Tianjin
Country: China

Status: Recruiting

Contact:
Last name: Yingmei Wang, PhD
Email: wangyingmei@tmu.edu.cn

Investigator:
Last name: Yingmei Wang, PhD
Email: Principal Investigator

Facility:
Name: Women's Hospital, Zhejiang University School of Medicine

Address:
City: Hangzhou
Zip: 310022
Country: China

Status: Recruiting

Contact:
Last name: Yuanming Shen, PhD
Email: 5312010@zju.edu.cn

Investigator:
Last name: Yuanming Shen, PhD
Email: Principal Investigator

Facility:
Name: Zhejiang Cancer Hospital, Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences

Address:
City: Hangzhou
Zip: 310022
Country: China

Status: Recruiting

Contact:
Last name: Yingli Zhang, PhD
Email: zhangyl@zjcc.org.cn

Investigator:
Last name: Yingli Zhang, PhD
Email: Principal Investigator

Start date: September 12, 2024

Completion date: December 12, 2030

Lead sponsor:
Agency: Tongji Hospital
Agency class: Other

Collaborator:
Agency: Southwest Hospital, China
Agency class: Other

Collaborator:
Agency: Women Hospital, School of Medicine, Zhejiang University
Agency class: Other

Collaborator:
Agency: Anhui Provincial Cancer Hospital
Agency class: Other

Collaborator:
Agency: Sichuan Cancer Hospital and Research Institute
Agency class: Other

Collaborator:
Agency: Gansu Provincial Maternal and Child Health Care Hospital
Agency class: Other

Collaborator:
Agency: Beijing Friendship Hospital
Agency class: Other

Collaborator:
Agency: Tianjin Medical University General Hospital
Agency class: Other

Collaborator:
Agency: Xiangya Hospital of Central South University
Agency class: Other

Collaborator:
Agency: West China Second University Hospital
Agency class: Other

Collaborator:
Agency: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Agency class: Other

Collaborator:
Agency: Zhejiang Cancer Hospital
Agency class: Other

Collaborator:
Agency: Shengjing Hospital
Agency class: Other

Collaborator:
Agency: Qilu Hospital of Shandong University
Agency class: Other

Collaborator:
Agency: Cancer Hospital of Guangxi Medical University
Agency class: Other

Source: Tongji Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06288360

Login to your account

Did you forget your password?