Ignite Creation Date:
2024-05-06 @ 4:15 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04921995
Status:
UNKNOWN
Last Update Posted:
2022-04-04
First Post:
2021-06-07
Brief Title:
Immunotherapy and Chemotherapy in Unresectable Recurrent Loco-regionally Advanced Nasopharyngeal Carcinoma
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
Postponing or Omitting Re-irradiation After Tislelizumab Plus Chemotherapy in Unresectable Recurrent Loco-regionally Advanced Nasopharyngeal Carcinoma
Status:
UNKNOWN
Status Verified Date:
2022-03
Last Known Status:
RECRUITING
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:
RETICULA-NPC
Brief Summary:
This is an open-label multi-center phase II trial to evaluate the safety and efficacy of postponing or omitting re-irradiation after systemic therapy with tislelizumab and chemotherapy in patients with unresectable recurrent loco-regionally advanced nasopharyngeal carcinoma Patients who did not respond to or progressed on another ICI are allowed to receive tislelizumab rechallenge as a subgroup
Detailed Description:
High dose reirradiation is usually recommended for unresectable recurrent loco-regionally advanced nasopharyngeal carcinoma However it potentially adds to the RT-related severe toxicities and deaths This trial aims to investigate the feasibility of postponing or even omitting re-irradiation based on effective first-line systemic therapy with tislelizumab and chemotherapy For patients that progressed after exposure to another PD-1 antibodytislelizumab rechallenge is accepted as a second subgroupIn this trial all patients will receive chemotherapy on doctors recommendation and PD-1 antibody tislelizumab 200mg every three weeks Patients with no response to the systemic therapy will receive salvage low dose re-irradiation delivered by SBRT while those who showed complete or partial response will continue maintenance therapy until progression death or intolerable toxicity and reirradiation will be postponed or omitted
Study Oversight
Has Oversight DMC:
None
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?:
None