Camrelizumab Combined With Chemotherapy and Apatinib for Extrapulmonary Neuroendocrine Carcinomas

Sponsor
Huazhong University of Science and Technology
Study ID
NCT05142865
Phase
PHASE2
Status
Unknown

Conditions

  • Advanced or Metastatic EP-NEC

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab — DRUG
    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.
  • Etoposide — DRUG
    100mg/m2 IV continuously on Day 1, 2 and 3 of each 21-day cycle during the induction phase (Cycles 1-4/6)
  • Carboplatin — DRUG
    AUC 5 mg/mL/min IV on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4/6)
  • Cisplatin — DRUG
    25mg/m2，continuously on Day 1, 2 and 3 of each 21-day cycle during the induction phase (Cycles 1-4/6)
  • Apatinib — DRUG
    250 mg given orally, once daily in 21-day cycle

Study Details

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）

Key Dates

Start date
Jan 14, 2022
Status verified
Nov 2021
Primary completion
Jan 14, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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 .

Primary Outcome Measure

Overall response rate （ORR） [ Time Frame: 2 years ]

Central Contacts