Neoadjuvant Treatment of Neuroendocrine Cervix Carcinomar With Camrelizumab Combined With Etoposide and Cisplatin

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

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.

Study Overview

• Status: Recruiting
• Conditions: Carcinoma; Cervix Carcinoma
• Intervention / Treatment: Drug: Karelizumab combined with etoposide and cisplatin

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: He Hai Xin; Phone Number: 13805056536; Email: 63804657@qq.com

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350014
      • Recruiting
      • Fujian Cancer Hospital
      • Contact: He Hai Xin; Phone Number: 13805056536; Email: 63804657@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age: 18 years ≤ Age ≤ 75 years, female patient. 2. 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.

3. 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).

4. ECOG PS 0-1 points. 5. The estimated postoperative survival time is greater than 3 months. 6. The main organs function normally and meet the following standards:

1. The blood routine test must meet the following criteria: (no blood transfusion within 14 days)

   1. HB ≥ 100g/L
   2. WBC ≥ 3 × 109/L
   3. ANC ≥ 1.5 × 109/L
   4. PLT ≥ 100 × 109/L

2. Biochemical examination must meet the following standards:

   1. BIL<1.5 times upper limit of normal value (ULN)
   2. ALT and AST<2.5ULN, GPT ≤ 1.5 × ULN

   3. Serum Cr ≤ 1ULN, endogenous creatinine clearance rate>60ml/min (Cockcroft Goult formula).

      7. Not participating in other clinical studies before and during treatment.

      8. Women of childbearing age must undergo a serum pregnancy study within 7 days before the first medication use, and the results should be negative. Female participants of childbearing age and male participants with partners of childbearing age must agree to contraception within 24 weeks after signing the informed consent form and the last administration of the study medication.

      9. The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up.

      Exclusion Criteria:

      1. Those who have a history of chemotherapy, radiation therapy, targeted drug therapy, or immunotherapy in the past.
      2. Patients who have Contraindication to surgical treatment and chemotherapy or whose physical condition and organ function do not allow large abdominal surgery.
      3. Distant metastasis.
      4. 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.
      5. 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.
      6. Accompanied by severe heart, lung, liver, and kidney diseases; Having neurological or mental illness; Individuals with jaundice or gastrointestinal obstruction and severe infections.
      7. Pregnant or lactating women.
      8. Suffering from coronary heart disease of grade I or above, arrhythmia (including prolonged QTc interval, female>470 ms), and cardiac dysfunction.
      9. Patients with abnormal coagulation function (INR>1.5, APTT>1.5 ULN).
      10. 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.
      11. Have a history of Interstitial lung disease (excluding radiation pneumonia without hormone treatment) and non infectious pneumonia.
      12. People who have been allergic to any component of Camrelizumab or any component of the study medication in the past.
      13. Researchers believe that it is not suitable for inclusion.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Drug: Karelizumab combined with etoposide and cisplatin; Karelizumab：200 mg，ivgtt，D1，q3w； Cisplatin：75 mg/m2，ivgtt，D1，q3w； Etoposide：100 mg/m2，ivgtt，D1~3，q3w; Other Names: Karelizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate	The proportion of participants achieving Complete Response (CR), Partial Response (PR) or Stable Disease (SD) according to RECIST1.1.	6-month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence rate of adverse events	The ratio of the number of cases with adverse events to the total number of cases available for evaluation.	5 years
Disease control rate	The proportion of participants achieving Complete Response (CR), Partial Response (PR) or Stable Disease (SD) according to RECIST1.1.	6-month
Progression-free survival	The period between the onset of treatment and the observation of disease progression or the occurrence of death for any reason.	6-month
Disease-free survival period	After radical treatment (complete surgical removal of the tumor), there is no time for the disease to recur.	6-month
1 year and 3 year overall survival rates	The proportion of patients who have survived for one and three years after comprehensive treatment.	1 year and 3 year
1-year and 3-year progression free survival rates	The probability that the patient's disease will not continue to worsen within one and three years.	1 year and 3 year
1-year and 3-year disease control rates	The proportion of patients with reduced or stable tumors within 1 and 3 years.	1 year and 3 year

Collaborators and Investigators

• Sponsor: Fujian Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2023
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: June 9, 2023
• First Submitted That Met QC Criteria: June 9, 2023
• First Posted (Actual): June 18, 2023

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Etoposide
• Other Study ID Numbers: Hhaixin

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No