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New treatment option for Carcinoma
Official title Neoadjuvant Treatment of Neuroendocrine Cervix Carcinomar With Camrelizumab Combined With Etoposide and Cisplatin
ClinicalTrials.gov ID: NCT05910177
What this study is testing
What is Karelizumab combined with etoposide and cisplatin?
Karelizumab combined with etoposide and cisplatin is an investigational medicine, being studied as a potential treatment for carcinoma.
Also referred to as Karelizumab.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, women only
You may be able to join if
- 1\. Age: 18 years ≤ Age ≤ 75 years, female patient. 2. Patients with cervical neuroendocrine carcinoma confirmed by histopathology or cytology (if...
- 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
You likely can't join if
- 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...
- Distant metastasis.
- Have any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, Uveitis, enteritis, hepatitis, hypophysitis...
- Have a history of immune deficiency, including positive Diagnosis of HIV/AIDS, or have other acquired or congenital immune deficiency diseases, or...
- Accompanied by severe heart, lung, liver, and kidney diseases; Having neurological or mental illness; Individuals with jaundice or gastrointestinal...
See the full eligibility 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...
- 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
- PLT ≥ 100 × 109/L
- Biochemical examination must meet the following standards:
- BIL\<1.5 times upper limit of normal value (ULN)
- ALT and AST\<2.5ULN, GPT ≤ 1.5 × ULN
- 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...
- 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...
- 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...
- 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...
- Have a history of Interstitial lung disease (excluding radiation pneumonia without hormone treatment) and non infectious pneumonia.
- People who have been allergic to any component of Camrelizumab or any component of the study medication in the past.
- Researchers believe that it is not suitable for inclusion.
The study team makes the final eligibility decision.
Where it's taking place
- Fuzhou, Fujian, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fuzhou, Fujian, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.