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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
200 mg, intravenously, 20-60 min. 2 times, every 21 days
260 mg/m² over 30 min, 3 times, every 21 days
4 h, 75-80 mg/m², 3 times, every 21 days
Anhui Provincial Cancer Hospital
Hefei, Anhui, China
RECRUITINGBeiing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Pathologic complete response
Pathologic complete response (pCR) refers to the absence of invasive/in situ cancer in the uterine cervix and/or lymph nodes
Time frame: undergoing surgery; up to 2 years.
Surgical Complications
Intraoperative bleeding, vascular injuries, bladder injuries, rectal injuries, and ureteral injuries were measured by the need for suture repair; occlusive nerve injuries were measured by complete severance, and vascular injuries required documentation of the site of injury. Postoperative complications included: cervical stenosis, cervical insufficiency, ureteral/bladder/rectal/vaginal fistula, internal hemorrhage, pelvic infection, lymphocyst, lymphatic fistula, lower extremity edema, lower extremity venous thrombosis, urinary retention, nerve injury, and bowel obstruction.
Time frame: during and after surgery; an average of 3 years.
Objective response rate
the proportion of patients who had either complete response or partial response, assessed by independent central reviewers according to RECIST, version 1.1.
Time frame: measured 3 weeks after the last dose of neoadjuvant treatment and before surgery; up to 2 years.
Positive surgical margin rate
A positive surgical margin means that cancer cells are present at the edge of the resection specimen.
Time frame: undergoing surgery; 2 years
event-free survival
Event-free survival (EFS) refers to the possibility of experiencing a defined set of events (including progression such as metastasis, death, etc.) following NACI treatment.
Time frame: 7 years
overall survival
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Radical hysterectomy + pelvic lymphadenectomy 士 para-aortic lymphadenectomy
The First Affiliated Hospital (Southwest Hospital), Army Medical University (Third Military Medical University)
Chongqing, Chongqing Municipality, China
RECRUITINGGansu Provincial Maternity and Child-care Hospital
Lanzhou, Gansu, China
RECRUITINGThe Affiliated Tumor Hospital of Guangxi Medical University
Nanning, Guangxi, China
RECRUITINGTongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGXiangya Hospital, Central South University
Changsha, Hunan, China
RECRUITINGShengjing Hospital of China Medical University
Shenyang, Liaoning, China
RECRUITINGSecond People's Hospital of Sichuan (Sichuan Cancer Hospital)
Chengdu, Sichuan, China
RECRUITINGTianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
RECRUITING...and 2 more locations
the time from enrollment to death
Time frame: 7 years
adverse event
an event that emerges during treatment having been absent pre-treatment, or worsens relative to the pre-treatment state.
Time frame: 7 years
Patient Reported Outcomes
including global quality of life and measures of sexual health
Time frame: 7 years