Neoadjuvant Chemoimmunotherapy and Extrafascial Hysterectomy for IB2 Cervical Cancer

NCT06289751 | Recruiting Phase 2 DMC

• 1 other identifier: NACI-CerV-004
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Cervical Cancer; Neoadjuvant Chemoimmunotherapy; Radical Hysterectomy; Extrafascial Hysterectomy

Outcome Measures

Primary Outcomes (1)

• 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.

  2-4 weeks after completion of neoadjuvant chemoimmunotherapy, approximately 2 years.

Secondary Outcomes (9)

• Objective Response Rate, ORR

  2-4 weeks after the last dose of neoadjuvant treatment and before surgery. an average of 2 years.

• Proportion of patients requiring postoperative adjuvant therapy

  during and after surgery; approximately 2 years

• Number of Participants with Treatment-Emergent Adverse Events as assessed by CTCAE v5.0

  Through study completion, an average of 5 year

• the surgical complication

  during and after surgery; approximately 3 years

• Pathologic Complete Response

  during the surgery; approximately 2 years.

Study Arms (1)

Neoadjuvant chemoimmunotherapy for ⅠB2 cervical cancer

EXPERIMENTAL

neoadjuvant chemotherapy + Cadonilimab + Radical hysterectomy/Extrafascial hysterectomy

Drug: Cadonilimab; Drug: Paclitaxel-albumin; Drug: Cisplatin; Procedure: Extrafascial hysterectomy; Procedure: Radical hysterectomy; Procedure: Cone biopsy

Interventions

Cadonilimab DRUG

10 mg/kg (body weight), 60 min, IV. Repeat every 3 weeks for a total of 3 cycles

Also known as: Cadonilimab Injection, AK104

Neoadjuvant chemoimmunotherapy for ⅠB2 cervical cancer

Paclitaxel-albumin DRUG

260 mg/m2 for 30 min. Repeat every 3 weeks for a total of 3 cycles.

Also known as: Injectable paclitaxel (albumin bound)

Neoadjuvant chemoimmunotherapy for ⅠB2 cervical cancer

Cisplatin DRUG

75-80 mg/m2, IV, 1 mg/min. Repeat every 3 weeks for a total of 3 cycles.

Also known as: Cisplatin injection

Neoadjuvant chemoimmunotherapy for ⅠB2 cervical cancer

Extrafascial hysterectomy PROCEDURE

Extrafascial hysterectomy + pelvic lymphadenectomy (or SLN mapping) (For participants who meet ConCerv criteria)

Neoadjuvant chemoimmunotherapy for ⅠB2 cervical cancer

Radical hysterectomy PROCEDURE

Radical hysterectomy + pelvic lymphadenectomy ± para-aortic lymphadenectomy (or SLN mapping) (For participants who do not meet ConCerv criteria)

Neoadjuvant chemoimmunotherapy for ⅠB2 cervical cancer

Cone biopsy PROCEDURE

Cold knife conization (CKC) (For participants with tumor size ≤2 cm after 3 cycles of chemo-immunotherapy)

Neoadjuvant chemoimmunotherapy for ⅠB2 cervical cancer

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Patient age ≥18 years and ≤70 years;
• ECOG score ≤1;
• Laboratory tests: WBC ≥3. 5×109/L, NEU ≥1. 5×109/L, PLT ≥100×109/L, serum bilirubin ≤1.5 times the upper limit of normal, aminotransferase ≤1.5 times the upper limit of normal, and BUN and Cr ≤normal;
• Be willing to follow up and good compliance;
• Be willing to sign the informed consent, including compliance with the requirements and restrictions listed in the informed consent and program.

You may not qualify if:

• 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;
• Received herbs with antitumor effects or drugs with immunomodulatory effects (e.g., thymidine, interferon, interleukin-2) within 2 weeks prior to the trial;
• Active systemic infection requiring systemic treatment;
• Serious infection within 4 weeks prior to the first dose, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia;
• 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 DNA \< 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;
• Immunodeficiency or human immunodeficiency virus (HIV antibody positive);
• 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;
• Known interstitial lung disease that is symptomatic or may interfere with detection or treatment of immune-associated pneumonia;
• Treatment with a live or attenuated vaccine administered within 4 weeks prior to the first trial dose, inactivated seasonal influenza virus vaccine is permitted;
• Patients who have received a prior allogeneic bone marrow transplant or solid organ transplant;
• History of primary malignant tumor within the last 5 years;
• Subjects who 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;

Sponsors & Collaborators

• Tongji Hospital: lead
• 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

Study Sites (2)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Related Publications (1)

• Hu Y, Cheng H, Chen J, Chen S, Han Y, Sun C, Chen G, Li K. Neoadjuvant chemotherapy plus cadonilimab followed by extra-fascial hysterectomy for International Federation of Gynecology and Obstetrics stage IB2 cervical cancer: a prospective, multi-center, single-arm, phase 2 trial. Int J Gynecol Cancer. 2026 Jan 5:104457. doi: 10.1016/j.ijgc.2025.104457. Online ahead of print.

  PMID: 41582028 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Cisplatin; Conization

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Ding Ma

  Tongji Hospital

  STUDY CHAIR

Central Study Contacts

Gang Chen

CONTACT

086-027-8362; gumpc@126.com

Jing Chen

CONTACT

086-027-8362; chenjing3223@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: a multicentre, single-arm, phase 2 trial

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: March 4, 2024
• Study Start: September 3, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): January 1, 2031
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)