Actively Recruiting

Phase 2
Age: 18Years - 70Years
FEMALE
ID06289751

Neoadjuvant Chemotherapy Plus Cadunilizumab Followed by Extrafascial Hysterectomy for FIGO Stage IB2 Cervical Cancer: a Multicenter, Single-arm, Phase 2 Trial.

Led by Tongji Hospital · Updated on 2024-09-19

50

Participants Needed

2

Research Sites

252 weeks

Total Duration

On this page

Sponsors

T

Tongji Hospital

Lead Sponsor

T

The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating a new treatment approach for women with stage IB2 cervical cancer. This study explores the use of neoadjuvant chemoimmunotherapy combined with extrafascial hysterectomy and pelvic lymph node dissection. The goal is to assess treatment response, side effects, complications, and patient survival, focusing on a less invasive surgical option that may reduce complications compared to traditional radical hysterectomy. The treatment involves giving patients Cadonilimab, a bispecific immunotherapy drug, with chemotherapy drugs paclitaxel-albumin and cisplatin. These drugs are administered intravenously every three weeks for three cycles. After neoadjuvant treatment, patients undergo either extrafascial hysterectomy with pelvic lymphadenectomy or radical hysterectomy, depending on their response and eligibility according to specific criteria. Some participants may also have a cone biopsy if their tumor size reduces sufficiently. Participants will be closely monitored from before treatment through surgery and for several years afterward. Researchers will evaluate tumor response, survival rates, side effects, surgical complications, urinary function, and patient-reported outcomes. Follow-up assessments will occur regularly for up to seven years to observe long-term effects and safety. The primary measure is the percentage of patients meeting criteria for conservative surgery about two years after treatment.

CONDITIONS

Brief Title

Neoadjuvant Chemoimmunotherapy and Extrafascial Hysterectomy for IB2 Cervical Cancer

Who Can Participate

Age: 18Years - 70Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinical diagnosis of untreated stage IB cervical cancer with IB2 (FIGO, 2018 criteria)
  • At least one measurable lesion at baseline based on MRI according to RECIST 1.1 criteria
  • Pathologically confirmed cervical squamous cell carcinoma (any grade), usual type adenocarcinoma (G1 or G2 / Silva A or B), or adenosquamous carcinoma (G1 or G2)
  • Positive PD-L1 expression with Combined Positive Score (CPS) 61
  • Age between 18 and 70 years
  • ECOG performance status score of 0 or 1
  • Laboratory tests within specified normal ranges for blood counts, liver and kidney function
  • Willingness to follow up and comply with study requirements
  • Signed informed consent including agreement to study restrictions
Not Eligible

You will not qualify if you...

  • Active, known, or suspected autoimmune disease except certain stable or mild autoimmune conditions
  • Prior treatment with immune checkpoint inhibitors or therapies targeting tumor immune mechanisms
  • Known allergy to any study drug component
  • Use of immunosuppressive drugs or corticosteroids above specified doses within 2 weeks before trial
  • Use of herbs or drugs with immunomodulatory effects within 2 weeks before trial
  • Active systemic infection or recent serious infection requiring hospitalization
  • Untreated or active hepatitis B or C infection without stable control
  • Known active tuberculosis or suspected active tuberculosis
  • Immunodeficiency or positive HIV antibody
  • Active inflammatory bowel disease or conditions affecting drug absorption
  • Known symptomatic interstitial lung disease
  • Live or attenuated vaccine within 4 weeks prior to first dose (except seasonal influenza vaccine)
  • Prior allogeneic bone marrow or solid organ transplant
  • History of primary malignant tumor within past 5 years
  • Major surgery or severe trauma within 28 days prior to first dose
  • History of gastrointestinal or female genital fistula
  • Uncontrolled co-morbidities including significant cardiovascular, bleeding, or gastrointestinal conditions
  • Pregnant or breastfeeding, or refusal of contraception during treatment
  • Participation in other interventional clinical trials
  • Any condition judged by investigator to pose risk or interfere with study evaluation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Neoadjuvant Chemoimmunotherapy

Duration - Approximately 9 weeks (3 cycles every 3 weeks)

Participants receive neoadjuvant treatment combining Cadonilimab, Paclitaxel-albumin, and Cisplatin in 3 cycles to reduce tumor size and improve surgical outcomes.

3 treatment visits every 3 weeks

Surgery

Duration - Single surgical event

Participants undergo extrafascial hysterectomy or radical hysterectomy with pelvic lymph node dissection based on their response to neoadjuvant therapy and eligibility criteria.

1 surgical visit (in-person)

Postoperative Follow-up

Duration - Up to 7 years

Participants are monitored for treatment response, surgical complications, urinary function recovery, and overall health over several years.

Regular follow-up visits over several years

Trial Site Locations

Total: 2 locations

1

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

Wuhan, Hubei, China, 430030

Actively Recruiting

2

Qilu Hospital of Shandong University

Jinan, Shandong, China, 250012

Actively Recruiting

Loading map...

Research Team

G

Gang Chen

J

Jing Chen

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Similar Trials

A Phase 1/2a Study of the Safety, Tolerability, and Prelimin...

Castration-Resistant Prostate Cancer (CRPC)

Actively Recruiting

4 locations

Evaluation of Diagnostic Value of 18F-T2 PET/ CT Imaging for...

Clear Cell Renal Cell Cancer (ccRCC)

Actively Recruiting

1 location

A Phase 1/2 Open Label, Dose Escalation and Expansion Study ...

Advanced Solid Tumor

Actively Recruiting

27 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

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.

Yingjie Hu, Hanxu Cheng, Jing Chen...

https://pubmed.ncbi.nlm.nih.gov/41582028