This study is an exploratory clinical trial to investigate the feasibility of neoadjuvant chemoimmunotherapy plus extrafascial hysterectomy and pelvic lymph node dissection in patients with stage IB2 (2018 FIGO) cervical cancer and to observe the response rate to treatment, adverse effects and complications, and to assess the survival rate of patients.
Clinical diagnosis of untreated stage IB cervical cancer with IB2 (FIGO, 2018 criteria; staging determined by two physicians of associate seniority or higher after gynecologic examination and imaging evaluation);
At least one measurable lesion at baseline according to RECIST 1.1 criteria, with lesion size based primarily on magnetic resonance imaging;
Pathologically confirmed diagnosis of cervical cancer, including cervical squamous cell carcinoma (any grade), usual type adenocarcinoma (G1 or G2 / Silva A or B), and adenosquamous carcinoma (G1 or G2);
Positive PD-L1 expression, Combined Positive Score (CPS) ≥1;
Subjects with an 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;
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 mechanism of tumor immune action;
Known hypersensitivity to any component and/or any excipient of the trial prescribed medication;
Immunosuppressive drugs or systemic corticosteroids for immunosuppression (> 10 mg/day of prednisone or other equivalent) within 2 weeks prior to trial dosing; topical, ophthalmic, intra-articular, intranasal, and inhaled corticosteroids are permitted;
Single group
Cadonilimab
Drug10 mg/kg (body weight), 60 min, IV. Repeat every 3 weeks for a total of 3 cycles
Paclitaxel-albumin
Drug260 mg/m2 for 30 min. Repeat every 3 weeks for a total of 3 cycles.
Cisplatin
Drug75-80 mg/m2, IV, 1 mg/min. Repeat every 3 weeks for a total of 3 cycles.
Extrafascial hysterectomy
Procedure/SurgeryExtrafascial hysterectomy + pelvic lymphadenectomy (or SLN mapping) (For participants who meet ConCerv criteria)
Radical hysterectomy
Procedure/SurgeryRadical hysterectomy + pelvic lymphadenectomy ± para-aortic lymphadenectomy (or SLN mapping) (For participants who do not meet ConCerv criteria)
Cone biopsy
Procedure/SurgeryCold knife conization (CKC) (For participants with tumor size ≤2 cm after 3 cycles of chemo-immunotherapy)
Percentage of patients meeting ConCerV criteria
Defined as the proportion (%) of all patients who met all ConCerV criteria approximately 2-4 weeks after completion of neoadjuvant chemoimmunotherapy. ConCerV criteria: no LVSI, negative margins, squamous cell carcinoma (any grade), usual type adenocarcinoma (G1 or G2 / Silva A or B) or adenosquamous carcinoma (G1 or G2), tumor size ≤2 cm, depth of infiltration ≤10 mm, no metastatic lesions seen.
Objective Response Rate, ORR
the proportion of patients who had either complete response or partial response, assessed by independent central reviewers according to RECIST, version 1.1.
Proportion of patients requiring postoperative adjuvant therapy
according to the criteria for postoperative adjuvant therapy in the 2024 NCCN Guidelines, with tumor size based on size assessed by imaging prior to conization of the uterine cervix, and other pathological findings based on a combination of conization and hysterectomy results
Number of Participants with Treatment-Emergent Adverse Events as assessed by CTCAE v5.0
A treatment-emergent adverse events (TEAE) is defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a study drug.
the surgical complication
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.
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Tongji Hospital
Lead sponsor
The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)
Collaborator
Women's Hospital School Of Medicine Zhejiang University
Collaborator
Southwest Hospital, China
Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborator
Sichuan Cancer Hospital and Research Institute
Collaborator
Qilu Hospital of Shandong University
Collaborator
Beijing Friendship Hospital
Collaborator
Tianjin Medical University
Collaborator
West China Second University Hospital
Collaborator
Xiangya Hospital of Central South University
Collaborator
Gansu Provincial Maternal and Child Health Care Hospital
Collaborator
Zhejiang Cancer Hospital
Collaborator
Shengjing Hospital
Collaborator
