Camrelizumab Combined With Chemotherapy and Apatinib for Extrapulmonary Neuroendocrine Carcinomas
NCT05142865 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2021-12-03
Summary
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)
Conditions
- Advanced or Metastatic EP-NEC
Interventions
- DRUG
-
Camrelizumab
Camrelizumab intravenous infusion was administered at a dose of 200 mg on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4/6) and maintenance phase ,until PD.
- DRUG
-
Etoposide
100mg/m2 IV continuously on Day 1, 2 and 3 of each 21-day cycle during the induction phase (Cycles 1-4/6)
- DRUG
-
AUC 5 mg/mL/min IV on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4/6)
- DRUG
-
25mg/m2,continuously on Day 1, 2 and 3 of each 21-day cycle during the induction phase (Cycles 1-4/6)
- DRUG
-
Apatinib
250 mg given orally, once daily in 21-day cycle
Sponsors & Collaborators
-
Huazhong University of Science and Technology
lead OTHER
Principal Investigators
-
Hong Qiu, MD · Tongji Hospital
-
Yuhong Dai, MD · Tongji Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-01-14
- Primary Completion
- 2024-01-14
- Completion
- 2024-12-31
Countries
- China
Study Locations
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