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