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. 2022 May 7;14:17588359221096214. doi: 10.1177/17588359221096214

Table 4.

Ongoing clinical trials of ICIs in LANPC.

Trial identifier Phase Treatment Patient population Enrollment Primary endpoint Completion date
Local-regional recurrent NPC NCT04376866 Phase III Concurrent and adjuvant toripalimaba or placebo plus CCRT Local–regional recurrent NPC 204 OS April 2028
NCT04453813 Phase III Concurrent and adjuvant toripalimaba or placebo plus CCRT Unresectable locally recurrent NPC 226 PFS July 2027
NCT04143984 Phase II Camrelizumaba plus IC followed by CIRT Locally recurrent NPC 146 PFS December 2025
NCT04534855 Phase II Treprilimaba Recurrent NPC after re-irradiation 40 ORR September 2025
NCT04778956 Phase III Toripalimaba plus surgery versus surgery alone for resectable recurrent NPC Resectable locally recurrent NPC 218 DFS March 2025
NCT04895345 Phase II TQB2450 + TQB2450 plus with IMRT Inoperable locally recurrent NPC 25 ORR December 2022
NCT05011227 Phase II Camrelizumaba + CT + endoscopic surgery Local recurrent NPC 100 OS August 2025
LANPC without prior therapy NCT04453826 Phase III Camrelizumaba or placebo plus chemoradiotherapy Staged as II–III NPC without response or positive EBV DNA after three cycles of IC and staged as IVa 338 PFS September 2028
NCT03700476 Phase III Sintilimaba or placebo combine with IC and CCRT Stage III–IVa LANPC 417 FFS January 2025
NCT04557020 Phase III Toripalimaba or placebo combine with IC and CCRT Clinical staged as T4 or N3 and without distant metastasis 200 PFS March 2024
NCT04447612 Phase II Durvalumab combine with IC and CCRT Locoregionally advanced stage III–IVa NPC 25 PFS June 2023
NCT04447326 Phase II Toripalimaba and endostar plus IC and CCRT T4 and N3 untreated NPC 106 PFS June 2026
NCT04782765 Phase II Camrelizumaba plus neoadjuvant chemotherapy followed by chemoradiotherapy NPC without distant metastasis 59 DFS rate of 3 years March 2025
NCT03734809 Phase II Neoadjuvant pembrolizumaba plus chemotherapy followed by concurrent pembrolizumab–cisplatin radiation, then maintenance of pembrolizumab monotherapy Untreated stage IVa NPC 46 PFS rate of 2 years December 2023
NCT03984357 Phase II Whole-course concurrent and adjuvant nivolumaba plus IC followed by RT alone High-risk LANPC 152 FFS August 2026
NCT04870905 Phase II IC-based CCRT plus adjuvant tislelizumaba T4 N1 or T1–4 N2–3 LANPC 100 FFS May 2026
NCT03544099 Phase II Adjuvant therapy with pembrolizumaba NPC with solely detectable EBV DNA after curative chemoradiation 63 DFS rate of 1 year December 2024
NCT03930498 Phase II Toripalimaba or placebo plus chemoradiotherapy High-risk recurrent NPC 43 ORR December 2023
NCT03427827 Phase III Camrelizumaba versus best supportive care Stage III–IVa LANPC after chemoradiation therapy 442 FFS February 2024
NCT03267498 Phase II Nivolumaba plus chemoradiation Stage II–IVb LANPC 40 Feasibility of treatment December 2021
NCT04910347 Phase II Consolidation nivolumaba after CCRT Stage II–IVa LANPC 57 PFS rate of 2 years December 2025
NCT04072107 Phase II GP IC + IMRT concurrent with CT and sintilimaba Detectable EBV DNA after three cycles of IC or with EBV DNA bounce during the induction phase 110 Failure-free survival December 2022

CCRT, concurrent chemoradiotherapy; CIRT, carbon-ion radiotherapy; DFS, disease-free survival; DNA, deoxyribonucleic acid; EBV, Epstein–Barr virus; GP, gemcitabine plus cisplatin; IC, induction chemotherapy; IMRT, intensity-modulated radiotherapy; LANPC, local–regionally advanced nasopharyngeal carcinoma; NPC, nasopharyngeal carcinoma; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; RT, radiotherapy; SBRT, stereotactic body radiation therapy; FFS, failure free survival.

a

Represents anti-PD-1 antibody; Endostar: VEGFR inhibitor; Durvalumab: anti-PD-L1 antibody; TQB 2450: anti-PD-L1 antibody