Neoadjuvant treatment for neuroendocrine cervix carcinoma using camrelizumab, 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 testing a new combination of treatments for patients with neuroendocrine cervix carcinoma to see if it can help them have better surgery results.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Fujian Cancer Hospital (other gov)
• Drugs / interventions: Camrelizumab, chemotherapy, immunotherapy, radiation, karelizumab
• Locations: 1 site (Fuzhou, Fujian)
• Trial ID: NCT05910177 on ClinicalTrials.gov

What this trial studies

This clinical trial is an exploratory study evaluating the safety and efficacy of camrelizumab combined with etoposide and cisplatin for the neoadjuvant treatment of neuroendocrine cervix carcinoma. Patients who respond positively will undergo radical surgery followed by adjuvant therapy, while those with stable or progressive disease will receive concurrent chemoradiotherapy. The study aims to assess the treatment's effectiveness in improving surgical outcomes for patients with this rare type of cervical cancer.

Who should consider this trial

Good fit: Ideal candidates are female patients aged 18 to 75 with confirmed neuroendocrine cervix carcinoma at FIGO stage I-II who are eligible for surgery.

Not a fit: Patients with advanced disease not suitable for surgery or those with significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve surgical outcomes and overall survival for patients with neuroendocrine cervix carcinoma.

How similar studies have performed: While there is limited data on this specific combination, similar approaches in treating neuroendocrine tumors have shown promise in other studies.

Eligibility criteria

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.

Where this trial is running

Fuzhou, Fujian

• Fujian Cancer Hospital — Fuzhou, Fujian, China (RECRUITING)

Study contacts

• Study coordinator: He Hai Xin

Conditions: Carcinoma, Cervix Carcinoma