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Safety and Efficacy of FOLFSIM Plus Toripalimab in the Treatment of Advanced or Metastatic Neuroendocrine Carcinoma

NCT03992911 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 336

Last updated 2019-06-20

No results posted yet for this study

Summary

This study is designed as Phase II/III. Phase II is aimed to evaluate safety and efficacy of Simmtecan and the 5-FU/LV regimen (FOLFSIM regimen) plus Toripalimab. Phase III is aimed to verify inferiority of the overall survival of FOLFSIM regimen plus Toripalimab in comparison with EP/EC in advanced or metastatic neuroendocrine cancer.

Conditions

  • Neuroendocrine Carcinoma of the Bladder

Interventions

DRUG

Simmtecan, 5-FU and l-LV

Simmtecan was administered intravenously at 80 mg per square meter on day1 with LV 400 mg per square meter administered as a 2-hour infusion, and 5-FU 2400 mg per square meter as a 46-hour infusion on day1 every 2 weeks in one course.

DRUG

Toripalimab

Toripalimab was administered intravenously at 240 mg on day 1 every 2 weeks in one course.

DRUG

Etoposide, Cisplatin

Etoposide was administered intravenously at 100 mg per square meter on day 1,2,3 with Cisplatin at 80 mg per square meter on day 1 every 3 weeks in one course.

DRUG

Etoposide, Carboplatin

Etoposide was administered intravenously at 100 mg per square meter on day 1,2,3 and Carboplatin with AUC 5mg/mL/min on day 1 every 3 weeks in one course.

Sponsors & Collaborators

  • Peking University

    lead OTHER

Principal Investigators

  • Lin Shen · Peking University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-19
Primary Completion
2022-06-20
Completion
2023-06-20

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03992911 on ClinicalTrials.gov