Adjuvant Vs Surgery Only in Early-stage Recurrent NPC

Phase 3

Recruiting

• Conditions: Recurrent Nasopharyngeal Carcinoma
• Interventions: Drug: Immunotherapy,Toripalimab Injection; Drug: Chemotherapy,Gemcitabine based regimen

• Registration Number: NCT06228079
• Lead Sponsor: Eye & ENT Hospital of Fudan University

Brief Summary

Adjuvant Therapy Versus Endoscopic Surgery Alone in Early-stage Recurrent Nasopharyngeal Carcinoma: A Multicenter Randomized Controlled Trial

Detailed Description

This study is an open-label, multicentered, evaluator-blinded , randomized clinical trial.

Patients with early-stage recurrent nasopharyngeal carcinoma were randomized into the control group and the experimental group. Patients in the control group would go through observation and follow-up after recurrent endoscopic surgery, while patients in the experimental group would be treated with adjuvant therapy such as chemotherapy and immunotherapy. A total of 176 subjects are required, with 88 patients in the control group and 88 patients in the experimental group.

Study Timeline

• Study First Submitted: 2023-12-21
• Study First Submitted QC: 2024-01-18
• Study First Posted: 2024-01-29
• Study Start: 2024-06-25
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-28
• Last Update Posted: 2024-12-31
• Primary Completion: 2028-06-30
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 176

Inclusion Criteria

1. Pathologically diagnosed with recurrent nasopharyngeal carcinoma;
2. Stage rT1 or rT2(superficial parapharyngeal space, distance to internal carotid artery ≤5mm)or rT3 (confined to the bottom wall of the sphenoid sinus),according to AJCC 8th edition;
3. Cervical lymph node metastasis can be controlled locally
4. Age 18 to 75 years;
5. Without distant metastasis;
6. Informed consent forms signed;
7. ≥6months from the accomplishment of radiation to recurrence
8. previously radiotherapy for only 1 course;
9. ECOG score 0-2 and can tolerate chemotherapy and immunotherapy
10. Sufficient organ function;
11. Undergone endoscopic surgery with negative pathological margin;

Exclusion Criteria

1. Participation in other interventional clinical trials;
2. Uncontrolled illnesses which will interfere with the ability to undergo therapy;
3. Suffering from another or multiple malignancy within 5 years (excluding fully treated basal cell or skin squamous cell carcinoma, cervical carcinoma in situ);
4. Any contradiction to immune and chemotherapy;
5. With serious autoimmune disease;
6. Currently usage of immunosuppressive agents or systemic glucocorticoid therapy (dosage>10mg/day prednisone or other glucocorticoids), and continuing to use them within 2 weeks before the first administration of trial drugs;
7. Severe allergic reactions to other monoclonal antibodies;
8. History of radioactive particle planting;
9. Vaccination with live vaccine within 4 weeks prior to initial administration or possibly during the study period;
10. Female patients who are at pregnancy or lactation;
11. Other situations that the researchers believe are not suitable for enrollment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The experimental group	Immunotherapy,Toripalimab Injection	Patients in the experimental group would be implemented with adjuvant therapy including chemotherapy and immunotherapy after endoscopic surgery.
The experimental group	Chemotherapy,Gemcitabine based regimen	Patients in the experimental group would be implemented with adjuvant therapy including chemotherapy and immunotherapy after endoscopic surgery.

Primary Outcome Measures

Name	Time	Method
DFS	From date of randomization until the date of first documented recurrence, metastasis or date of death from any cause, whichever came first, assessed up to 24 months	Disease free survival

Secondary Outcome Measures

Name	Time	Method
OS	From randomization to death of any cause,assessed up to 60 months	Overall Survival
LRFS	From randomization to local recurrence or death,assessed up to 24 months	Local recurrence free survival
DMFS	From randomization to distant metastasis or death, assessed up to 24 months	Distant metastasis free survival
1-and 2-year DFS rate	end of 1st year, end of 2nd year	one- and two-year disease free survival
1-and 2-year OS rate	end of 1st year, end of 2nd year	one- and two-year overall survival rate

Trial Locations

Locations (7)

Eye& ENT Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China

Fujian Medical University Union Hospital; 🇨🇳 Fuzhou, China

The People's Hospital of Guangxi Zhuang Autonomous Region; 🇨🇳 Nanning, China

Changhai Hospital; 🇨🇳 Shanghai, China

Shanghai Sixth People's Hospital; 🇨🇳 Shanghai, China

Shanghai Zhongshan Hospital; 🇨🇳 Shanghai, China

Shenzhen Second People's Hospital; 🇨🇳 Shenzhen, China