NCT06987123

TC as Adjuvant Therapy After Surgery for Locally Recurrent Resectable Nasopharyngeal Carcinoma: a Single-arm Clinical Trial

Toripalimab in Combination With Capecitabine as Adjuvant Therapy After Surgery for Locally Recurrent Resectable Nasopharyngeal Carcinoma: a Single-arm Clinical Trial

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Regarding the application value of capecitabine metronome chemotherapy's regulatory effect on the immune microenvironment in nasopharyngeal carcinoma, many studies in recent years have confirmed that metronome chemotherapy and immunotherapy are safe and effective in resectable recurrent nasopharyngeal carcinoma. Therefore, the investigators plan to conduct a "single-arm clinical study on adjuvant therapy of toripalimab combined with capecitabine after Surgery for locally recurrent resectable nasopharyngeal carcinoma" to explore the efficacy and safety of toripalimab combined with capecitabine as adjuvant therapy after salvage surgery for resectable recurrent nasopharyngeal carcinoma. If this study is confirmed, it is expected to provide a new treatment model for patients with resectable recurrent nasopharyngeal carcinoma.

Detailed description

Regarding the application value of capecitabine metronome chemotherapy's regulatory effect on the immune microenvironment in nasopharyngeal carcinoma, many studies in recent years have confirmed that metronome chemotherapy and immunotherapy are safe and effective in resectable recurrent nasopharyngeal carcinoma. Therefore, the investigators plan to conduct a "single-arm clinical study on adjuvant therapy of toripalimab combined with capecitabine after Surgery for locally recurrent resectable nasopharyngeal carcinoma" to explore the efficacy and safety of toripalimab combined with capecitabine as adjuvant therapy after salvage surgery for resectable recurrent nasopharyngeal carcinoma. If this study is confirmed, it is expected to provide a new treatment model for patients with resectable recurrent nasopharyngeal carcinoma.The diagnosis was pathologically confirmed as locally recurrent nasopharyngeal carcinoma. According to the TNM staging of recurrent nasopharyngeal carcinoma (AJCC, 8th Edition, 2018), resectable nasopharyngeal diseases: rT1 (the tumor was confined to the nasopharynx, oropharynx and/or nasal cavity, and did not involve the parapharynx); rT2 (The tumor is confined to the superficial septum beside the pharynx, more than 0.5 cm away from the internal carotid artery) and rT3 (the tumor is confined to the basal wall of the sphenoid sinus, more than 0.5 cm away from the internal carotid artery and the cavernous sinus); Resectable recurrent regional lymph nodes (rN1-3), without involvement of the anterior vertebral fascia, cervical vertebrae or common carotid artery/internal carotid artery.

Conditions

• Nasopharyngeal Carcinoma (NPC)

Interventions

Type	Name	Description
DRUG	Toripalimab	Toripalimab 240 mg, administered on the first day, Q3W × 17 cycles
DRUG	Capecitabine	Capecitabine 650 mg/m2 twice a day, oral administration, d1-21, Q3W × 17 cycles
PROCEDURE	salvage surgery	The specific steps of high-frequency electrosurgical knife treatment for localized recurrent nasopharyngeal carcinoma are as follows: 1. It must be performed under general anesthesia, with the complete resection of the nasopharyngeal tumor and its sufficient safe boundary through both nasal cavities under the guidance of nasal endoscopy. When marking the surgical margin, the anterior margin should reach 1-2cm in front of the posterior column of the nasal septum, and the upper margin can reach about 0.5-1cm to the upper margin of the posterior nostril. The lateral and lower margins are designed individually based on the size and location of the tumor. The basic principle is to ensure a safe margin of 0.5-1.0cm, and then use low-temperature plasma ablation. Ablate the tumor tissue and the normal tissue at the resection margin layer by layer from the upper resection margin to the lower resection margin until no obvious tumor residue was observed with the naked eye. 2. Rinse the surgical c

Timeline

• Start date: 2025-05-18
• Primary completion: 2029-06-01
• Completion: 2029-06-01
• First posted: 2025-05-23
• Last updated: 2025-05-23