Huazhong University of Science and Technology
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This is an open-label,single-arm, phase II exploratory study that evaluates the efficacy and safety of Camrelizumab combined with Chemotherapy (carboplatin or cisplatin + etoposide)and Apatinib as First Line treatment in Advanced or Metastatic Extrapulmonary Neuroendocrine Carcinomas(EP-NEC)
Advanced or Metastatic EP-NEC
Camrelizumab
Etoposide
Carboplatin
Cisplatin
Apatinib
Phase 2
Study Type : | Interventional |
Estimated Enrollment : | 30 participants |
Masking : | None (Open Label) |
Primary Purpose : | Treatment |
Official Title : | A Phase II Clinical Study Evaluating the Safety and Efficacy of Camrelizumab Combined With Chemotherapy and Apatinib as First Line Treatment in Advanced or Metastatic Extrapulmonary Neuroendocrine Carcinomas(EP-NEC) |
Actual Study Start Date : | January 14, 2022 |
Estimated Primary Completion Date : | January 14, 2024 |
Estimated Study Completion Date : | December 31, 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: Camrelizumab+ Chemotherapy+ Apatinib Induction stage:Camrelizumab 200 mg administered intravenously (IV) on Day 1 +Etoposide (100mg/m2 IV continuously on Day 1, 2 and 3)+Carboplatin(AUC 5 mg/mL/min IV on Day 1) or Cisplatin(25mg/m2,continuously on Day 1, 2 and 3) Q3W for 4-6 cycles; Maintenance stage:Camrelizumab 200 mg administered intravenously (IV) on Day 1 of each 21-day cycle plus Apatinib capsules 250 mg given orally, once daily in 21-day cycle . |
Drug: Camrelizumab Drug: Etoposide Drug: Carboplatin Drug: Cisplatin Drug: Apatinib |
Ages Eligible for Study: | 18 Years to 75 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Tongji Hospital,Tongji Medical College Affiliated,Huazhong University of Science & Technology
Wuhan, Hubei, China, 430030