Neoadjuvant vs Adjuvant in Locally Advanced Recurrent NPC | NCT06235203

Studies
Neoadjuvant vs Adjuvant in Locally Advanced Recurrent NPC

NCT06235203

Sponsor

Eye & ENT Hospital of Fudan University

Status

Recruiting

Last Update Posted

Jun 3, 2025Actual

Enrollment

154Estimated

Phase

Phase 3

Conditions

Recurrent Nasopharyngeal Carcinoma

Interventions

endoscopic surgery
Neoadjuvant therapy,Toripalimab Injection and Gemcitabine based therapy
Adjuvant therapy in experimental group,Toripalimab Injection and Gemcitabine based therapy
Adjuvant therapy in control group,Toripalimab Injection and Gemcitabine based therapy

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 9, 2024Actual

Primary Completion Date

Jun 30, 2027Estimated

Completion Date

Jun 30, 2027Estimated

First Submitted Date

Dec 21, 2023

First Submission Date that Met QC Criteria

Jan 23, 2024

First Posted Date

Jan 31, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 28, 2025

Last Update Posted Date

Jun 3, 2025Actual

Name	Class
Shanghai Zhongshan Hospital	OTHER
Shanghai 6th People's Hospital	OTHER
Changhai Hospital	OTHER
Fujian Medical University Union Hospital

Description Module

Brief Summary

A multicenter randomized controlled study of surgery combined with neoadjuvant and adjuvant therapy for locally advanced recurrent nasopharyngeal carcinoma in comparison to surgery combined with adjuvant therapy

Detailed Description

Eligible patients are randomized into the control group and the experimental group.

Patients in the experimental group would be administrated 2 courses of neoadjuvant therapy before surgery.After endoscopic surgery, patients would continue to receive 2-4 courses of chemotherapy and 8 courses of immunotherapy.

Patients in the control group would firstly receive endoscopic surgery, followed by chemotherapy and immunotherapy. In total, 4 to 6 courses of chemotherapy and 10 courses of immunotherapy would be administrated.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

154Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
The control group	Active Comparator	Endoscopic surgery + adjuvant therapy	Procedure: endoscopic surgery Drug: Adjuvant therapy in control group,Toripalimab Injection and Gemcitabine based therapy
The experimental group	Experimental	Neoadjuvant therapy +endoscopic surgery + adjuvant therapy	Procedure: endoscopic surgery Drug: Neoadjuvant therapy,Toripalimab Injection and Gemcitabine based therapy Drug: Adjuvant therapy in experimental group,Toripalimab Injection and Gemcitabine based therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
endoscopic surgery	Procedure	The tumor was resected by endoscopic nasopharyngectomy.	The control group The experimental group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
EFS	Event free survival	From randomization and any events(like:progression or toxic effects precluding surgery;inability to resect all gross disease; progression;surgical complications precluding initiation of adjuvant therapy; recurrence;death) up to 1 year

Secondary Outcomes

Measure	Description	Time Frame
OS	Overall Survival	Time interval of randomization and death of any cause, up to 5 years
DFS	Disease free survival	From randomization to recurrence, metastasis or death, up to 1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pathologically diagnosed with recurrent nasopharyngeal carcinoma;
Resectable disease staging rT2 (deep parapharyngeal space, or distance to the internal carotid ≤5mm) or rT3 (excluding the lesions confined to the basal wall of sphenoid sinus), rT4, according to AJCC 8th edition;
Cervical lymph node metastasis can be controlled locally;
Aged 18 to 75 years;
Informed consent forms signed to participate in the trial;
Without distant metastasis;
≥6months from the accomplishment of radical radiation to recurrence
previously only 1 course of radiotherapy;
Sufficient organ function;
ECOG score 0-2 and can tolerate surgery,chemotherapy and immunotherapy.

Exclusion Criteria:

Participate in other interventional clinical trials;
Uncontrolled illnesses that interfere with the therapy;
Suffering from another or multiple malignancy within 5 years (excluding fully treated basal cell or skin squamous cell carcinoma, cervical carcinoma in situ, etc.);
Any contradiction to surgery;
With serious autoimmune disease;
The patient is currently using immunosuppressive agents or systemic hormone therapy to achieve immunosuppressive effects (dosage>10mg/day prednisone or other glucocorticoids), and continues to use them within 2 weeks before the first administration;
Severe allergic reactions to other monoclonal antibodies;
History of radioactive particle planting;
Vaccination with live vaccine within 4 weeks prior to initial administration or possibly during the study period;
Female patients who are at pregnancy or lactation;
Other situations that the researchers believe not suitable for enrollment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D009303	Nasopharyngeal Neoplasms
D010610	Pharyngeal Neoplasms
D010039	Otorhinolaryngologic Neoplasms
D006258	Head and Neck Neoplasms
D009371	Neoplasms by Site
D009302	Nasopharyngeal Diseases
D010608	Pharyngeal Diseases
D009057	Stomatognathic Diseases
D010038	Otorhinolaryngologic Diseases

ID	Term
D004724	Endoscopy
D020360	Neoadjuvant Therapy
C000656314	toripalimab
D035061	Control Groups

ID	Term
D003949	Diagnostic Techniques, Surgical
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D019060	Minimally Invasive Surgical Procedures
D013514	Surgical Procedures, Operative
D003131	Combined Modality Therapy
D013812	Therapeutics
D015340	Epidemiologic Research Design
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D012107	Research Design
D008722	Methods