Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2026-01-06 @ 6:05 AM
Study NCT ID:
NCT06732258
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-27
First Post:
2024-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low-dose Radiotherapy Combined with Concurrent Chemotherapy, Toripalimab and Tifcemalimab in the Treatment of ES-SCLC
Sponsor:
Sichuan University
Organization:
Study Overview
Official Title:
Exploratory Clinical Study of Low-dose Radiotherapy Combined with Concurrent Chemotherapy, Toripalimab and Tifcemalimab in First-line Treatment of Extensive-Stage Small Cell Lung Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the tolerability and safety of Low-dose radiotherapy combined with concurrent Chemotherapy, Toripalimab and Tifcemalimab in first-line treatment of Extensive-Stage Small Cell Lung Cancer, and to determine the RP2D.
Detailed Description:
This is a single-center, single-arm, exploratory clinical study to evaluate the safety and tolerability of low-dose radiotherapy (LDRT) concurrent chemotherapy combined with toripalimab and Tifcemalimab (JS004) in the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC). Approximately 6-12 subjects were planned to be enrolled in this clinical study. The study will adopt a "3 + 3" dose escalation design, and the observation period for dose-limiting toxicities (DLTs) is 21 days after the first dose administration. Patients who meet the inclusion criteria will receive toripalimab 240 mg q3w, tifcemalimab 100 mg or 200 mg q3w until disease progression or intolerable toxicity; cisplatin for injection 75 mg/m2 or carboplatin AUC = 5, q3w, etoposide 100 mg/m2, d1, d2, d3, q3w for 4-6 cycles; low-dose radiotherapy with a total dose of 15 Gy, radiotherapy will be started on Cycle 1 Day 1 in 5 divided doses (15 Gy/5F).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: