Phase 3 Study of Toripalimab Plus Chemoradiotherapy Versus Chemoradiotherapy Alone for Recurrent Nasopharyngeal Carcinoma

What this Trial Is About

Researchers are investigating treatments for locoregionally recurrent nasopharyngeal carcinoma, a type of cancer common in parts of Asia and Africa. This phase 3, multicenter, randomized controlled trial evaluates the effectiveness and side effects of adding the PD-1 antibody Toripalimab to the standard cisplatin concurrent chemoradiotherapy compared to chemoradiotherapy alone. The study aims to improve survival and reduce toxicity in patients whose cancer has returned locally despite previous radiation treatment. Participants are assigned to one of two groups. One group receives Toripalimab 240 mg combined with cisplatin 100 mgm2 every three weeks during intensity modulated radiotherapy IMRT given at a total dose of 60-66 Gy in fractions of 1.8-2.0 Gy, followed by nine cycles of Toripalimab every three weeks as additional immunotherapy. The other group receives cisplatin with IMRT alone, following the same dosing and schedule without Toripalimab. During the study, participants will have regular assessments including survival tracking up to five years, monitoring of disease progression, response to treatment at three months, adverse events over five years, and quality of life evaluation after one year. Researchers will conduct imaging and laboratory tests to monitor safety and effectiveness. The total participation period varies, but primary outcomes focus on long-term survival benefits and treatment tolerance.

Toripalimab for Local-regional Recurrent Nasopharyngeal Carcinoma