Neoadjuvant Chemoimmunotherapy and Extrafascial Hysterectomy for IB2 Cervical Cancer

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorTongji Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Cadonilimab
  • Paclitaxel-albumin
  • Cisplatin
  • Extrafascial hysterectomy
  • Radical hysterectomy
  • Cone biopsy

Treatment groups

50 Participants
are divided into 1 treatment group

Sponsors and collaborators

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