MedTrace Logo

Toripalimab Plus Anlotinib for the Maintenance of Extensive Stage Small Cell

NCT06441344 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2024-06-04

No results posted yet for this study

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

Conditions

  • SCLC
  • Maintenance Treatment

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

Sponsors & Collaborators

  • Taizhou Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2026-05-01
Completion
2030-05-01

More Related Trials

Entities

Diseases

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 NCT06441344 on ClinicalTrials.gov