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

NCT06987123 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2025-05-23

No results posted yet for this study

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.

Conditions

  • Nasopharyngeal Carcinoma (NPC)

Interventions

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

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-18
Primary Completion
2029-06-01
Completion
2029-06-01

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06987123 on ClinicalTrials.gov