Neoadjuvant Vs Adjuvant in Locally Advanced Recurrent NPC

Phase 3

Recruiting

• Conditions: Recurrent Nasopharyngeal Carcinoma
• Interventions: Procedure: endoscopic surgery; Drug: Adjuvant therapy in control group,Toripalimab Injection and Gemcitabine based therapy; Drug: Neoadjuvant therapy,Toripalimab Injection and Gemcitabine based therapy; Drug: Adjuvant therapy in experimental group,Toripalimab Injection and Gemcitabine based therapy

• Registration Number: NCT06235203
• Lead Sponsor: Eye & ENT Hospital of Fudan University

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.

Study Timeline

• Study First Submitted: 2023-12-21
• Study First Submitted QC: 2024-01-23
• Study First Posted: 2024-01-31
• Study Start: 2024-05-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-28
• Last Update Posted: 2024-12-31
• Primary Completion: 2027-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

1. Pathologically diagnosed with recurrent nasopharyngeal carcinoma;
2. 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;
3. Cervical lymph node metastasis can be controlled locally;
4. Aged 18 to 75 years;
5. Informed consent forms signed to participate in the trial;
6. Without distant metastasis;
7. ≥6months from the accomplishment of radical radiation to recurrence
8. previously only 1 course of radiotherapy;
9. Sufficient organ function;
10. ECOG score 0-2 and can tolerate surgery,chemotherapy and immunotherapy.

Exclusion Criteria

1. Participate in other interventional clinical trials;
2. Uncontrolled illnesses that interfere with the 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, etc.);
4. Any contradiction to surgery;
5. With serious autoimmune disease;
6. 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;
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 not suitable for enrollment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The experimental group	endoscopic surgery	Neoadjuvant therapy +endoscopic surgery + adjuvant therapy
The control group	Adjuvant therapy in control group,Toripalimab Injection and Gemcitabine based therapy	Endoscopic surgery + adjuvant therapy
The experimental group	Adjuvant therapy in experimental group,Toripalimab Injection and Gemcitabine based therapy	Neoadjuvant therapy +endoscopic surgery + adjuvant therapy
The control group	endoscopic surgery	Endoscopic surgery + adjuvant therapy
The experimental group	Neoadjuvant therapy,Toripalimab Injection and Gemcitabine based therapy	Neoadjuvant therapy +endoscopic surgery + adjuvant therapy

Primary Outcome Measures

Name	Time	Method
EFS	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	Event free survival

Secondary Outcome Measures

Name	Time	Method
DFS	From randomization to recurrence, metastasis or death, up to 1 year	Disease free survival
LRFS	From randomization to local recurrence or death, up to 1 year	Local recurrence free survival
DMFS	From randomization to distant metastasis or death, up to 1 year	Distant metastasis free survival
pCR	Time point of pathological tumor evaluation after sugery, around 2 weeks after sugery	pathologic complete response
ORR	Time point of imaging evaluation before treatment(or randomization) and before surgery,up to 1 year	Objective response rate,Proportion of CR, PR in all patients.
1-and 2-year OS rate	one- and two-year	one- and two-year overall survival rate
DCR	Time point of imaging evaluation before treatment(or randomization) and before surgery,up to 1 year	Disease Control Rate,Proportion of CR, PR and SD in all patients.
1-and 2-year PFS rate	one- and two-year	one- and two-year progression free survival rate
OS	Time interval of randomization and death of any cause, up to 5 years	Overall Survival
DoR	First date of response to the date of progression, up to 5 years	Duration of response,the time from the first assessment of the tumour as CR or PR to the first assessment of PD or death from any cause (whichever event occurs first).

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