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NOT YET RECRUITING
NCT06441344
PHASE3

Toripalimab Plus Anlotinib for the Maintenance of Extensive Stage Small Cell

Sponsor: Taizhou Hospital

View on ClinicalTrials.gov

Summary

This is a randomized, open, multicenter Phase III clinical study. A total of 136 participants are planned to be enrolled and randomly assigned to either the experimental group (platinum+etoposide → toripalimab plus anlotinib) or the control group (platinum+etoposide+ toripalimab → toripalimab) in a 1:1 ratio. The primary efficacy measures include PFS, while secondary endpoints include OS, DOR, ORR, DCR, progression free survival at 6 and 12 months, overall survival at 12 and 18 months, health-related quality of life (FACT-L), safety, etc. And in the III clinical study, tissue samples were collected before treatment, and tumor tissue and blood samples were taken from some patients after 3 cycles of maintenance treatment and treatment progression for single-cell sequencing and transcriptome sequencing to verify the underlying mechanism research

Official title: First-line Etoposide Combined With Platinum-based Chemotherapy Followed by Toripalimab Plus Anlotinib for the Maintenance of Extensive Stage Small Cell Carcinoma - A Randomized, Controlled, Multicenter Phase III Clinical Study

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

136

Start Date

2024-07-01

Completion Date

2030-05-01

Last Updated

2024-06-04

Healthy Volunteers

No

Interventions

DRUG

Toripalimab plus Anlotinib

For patients who did not progress after standard chemotherapy, toripalimab plus anlotinib maintenance therapy was used

DRUG

Toripalimab

For patients who did not progress after standard chemotherapy+toripalimab, toripalimab maintenance therapy was used