NCT05142865

Camrelizumab Combined With Chemotherapy and Apatinib for Extrapulmonary Neuroendocrine Carcinomas

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）

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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	Carboplatin	AUC 5 mg/mL/min IV on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4/6)
DRUG	Cisplatin	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

Timeline

• Start date: 2022-01-14
• Primary completion: 2024-01-14
• Completion: 2024-12-31
• First posted: 2021-12-03
• Last updated: 2021-12-03

Locations

1 site across 1 country: China