Trials / Unknown
UnknownNCT05092217
Tirelizumab Plus Surgery vs Surgery Alone for Recurrent Nasopharyngeal Carcinoma
Tirelizumab Plus Surgery vs Surgery Alone for Recurrent Nasopharyngeal Carcinoma：a Prospecitve, Parallel, Phase II, Randomized Clinical Trial
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- Sponsor
- Eye & ENT Hospital of Fudan University · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
Through open-label, single-center, randomised clinical trials, we intend to demonstrate that PD-1 treatment added to salvage surgery could further decrease the rate of disease progression and improve the survival outcome of patients with locally recurrent nasopharyngeal carcinoma compared with those treated with salvage surgery alone.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tirelizumab | Tirelizumab: 200 mg, intravenous injection over 60 minutes (Q3W); Tirelizumab should be applied since 2-6 weeks after surgery until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, investigator decision, or 1 year. |
| PROCEDURE | salvage surgery | Endoscopic nasopharyngectomy for recurrent nasopharyngeal tumor |
Timeline
- Start date
- 2021-10-20
- Primary completion
- 2023-10-20
- Completion
- 2024-10-20
- First posted
- 2021-10-25
- Last updated
- 2021-10-25
Source: ClinicalTrials.gov record NCT05092217. Inclusion in this directory is not an endorsement.