Neoadjuvant Immunochemotherapy in PD-L1-negative LACC

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

About this trial

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.

Eligibility criteria

Qualifiers

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);

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.

Histologically confirmed squamous carcinoma, adenocarcinoma (common type) or adenosquamous carcinoma of the cervix;

Negative PD-L1 expression on preoperative pathological examination (Combined positive score < 1);

Disqualifiers

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 tumor's immune mechanism of action;

Known hypersensitivity to any component and/or any excipient of the trial prescribed medication;

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;

Trial design

Treatments tested in this trial

  • Camrelizumab
  • Paclitaxel-albumin
  • Cisplatin
  • radical surgery

Treatment groups

40 Participants
are divided into 1 treatment group

Sponsors and collaborators

Tongji Hospital

Lead sponsor

Southwest Hospital, China

Collaborator

Women's Hospital School Of Medicine Zhejiang University

Collaborator

Anhui Provincial Cancer Hospital

Collaborator

Sichuan Cancer Hospital and Research Institute

Collaborator

Gansu Provincial Maternal and Child Health Care Hospital

Collaborator

Beijing Friendship Hospital

Collaborator

Tianjin Medical University General Hospital

Collaborator

Xiangya Hospital of Central South University

Collaborator

West China Second University Hospital

Collaborator

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Collaborator

Zhejiang Cancer Hospital

Collaborator

Shengjing Hospital

Collaborator

Qilu Hospital of Shandong University

Collaborator

Cancer Hospital of Guangxi Medical University

Collaborator