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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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∙ 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:

• 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 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.

Locations
Other Locations
China
Fujian Cancer Hospital
RECRUITING
Fuzhou
Contact Information
Primary
He Hai Xin
63804657@qq.com
13805056536
Time Frame
Start Date: 2023-12-28
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 30
Treatments
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)
Sponsors
Leads: Fujian Cancer Hospital

This content was sourced from clinicaltrials.gov