A Single Arm, Exploratory Clinical Study on the Neoadjuvant Treatment of Neuroendocrine Cervix Carcinoma With Camrelizumab Combined With Etoposide and Cisplatin

Fujian Cancer Hospital1 site in 1 country30 target enrollmentDecember 28, 2023

ConditionsCarcinoma Cervix Carcinoma

InterventionsKarelizumab combined with etoposide and cisplatin

DrugsKarelizumab combined with etoposide and cisplatin

Overview

Phase: Phase 2
Intervention: Karelizumab combined with etoposide and cisplatin
Conditions: Carcinoma
Sponsor: Fujian Cancer Hospital
Enrollment: 30
Locations: 1
Primary Endpoint: Objective Response Rate
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Detailed Description

This study is a single arm, exploratory clinical study aimed at evaluating the efficacy and safety of karelizumab combined with etoposide and cisplatin in the neoadjuvant treatment of neuroendocrine cervix carcinoma.Following this, patients achieving complete or partial response will proceed to radical surgery and adjuvant therapy, while those with stable or progressive disease, or considered unsuitable for surgery by gynecological oncologists, will transfer to concurrent chemoradiotherapy.

Registry

clinicaltrials.gov

Start Date

December 28, 2023

End Date

August 31, 2026

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Fujian Cancer Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age: 18 years ≤ Age ≤ 75 years, female patient.
•Patients with cervical neuroendocrine carcinoma confirmed by histopathology or cytology (if mixed type carcinoma, the composition of neuroendocrine carcinoma is\>60%), whose FIGO stage is stage I-II, and who can be operated according to the gynecological examination of an experienced Chief physician.
•According to the RECIST 1.1 standard, patients have at least one measurable diameter target lesion (tumor lesion CT scan length ≥ 10mm, lymph node lesion CT scan short diameter ≥ 15mm, scan layer thickness 5mm).
•ECOG PS 0-1 points.
•The estimated postoperative survival time is greater than 3 months.
•The main organs function normally and meet the following standards:
•The blood routine test must meet the following criteria: (no blood transfusion within 14 days)
•HB ≥ 100g/L
•WBC ≥ 3 × 109/L
•ANC ≥ 1.5 × 109/L

Exclusion Criteria

•Those who have a history of chemotherapy, radiation therapy, targeted drug therapy, or immunotherapy in the past.
•Patients who have Contraindication to surgical treatment and chemotherapy or whose physical condition and organ function do not allow large abdominal surgery.
•Distant metastasis.
•Have any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, Uveitis, enteritis, hepatitis, hypophysitis, Vasculitis, Myocarditis, nephritis, Hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); Except for Vitiligo or recovered childhood asthma/allergy patients who do not need any intervention after adulthood; Autoimmune mediated hypothyroidism treated with stable doses of thyroid replacement hormone; Type I diabetes with a stable dose of insulin.
•Have a history of immune deficiency, including positive Diagnosis of HIV/AIDS, or have other acquired or congenital immune deficiency diseases, or have a history of organ transplantation and allogeneic bone marrow transplantation.
•Accompanied by severe heart, lung, liver, and kidney diseases; Having neurological or mental illness; Individuals with jaundice or gastrointestinal obstruction and severe infections.
•Pregnant or lactating women.
•Suffering from coronary heart disease of grade I or above, arrhythmia (including prolonged QTc interval, female\>470 ms), and cardiac dysfunction.
•Patients with abnormal coagulation function (INR\>1.5, APTT\>1.5 ULN).
•The subject has clinical cardiovascular symptoms or diseases that cannot be well controlled, including but not limited to: (1) NYHA grade II or above heart failure, (2) unstable angina pectoris, (3) myocardial infarction within 1 year, (4) clinically significant supraventricular or ventricular arrhythmias that are still poorly controlled without or after clinical intervention.

Arms & Interventions

Karelizumab combined with etoposide and cisplatin group

The cycle dose should be strictly controlled according to the experimental design. The order of administration is as follows: Karelizumab → Cisplatin → Etoposide (with an interval of at least 30 minutes)

Intervention: Karelizumab combined with etoposide and cisplatin