Actively Recruiting
Neoadjuvant-Adjuvant Versus Adjuvant-Only Therapy Combined With Endoscopic Surgery in Advanced Recurrent Nasopharyngeal Carcinoma A Multicenter Randomized Controlled Trial
Led by Eye & ENT Hospital of Fudan University · Updated on 2025-06-03
154
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
Sponsors
E
Eye & ENT Hospital of Fudan University
Lead Sponsor
S
Shanghai Zhongshan Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying treatments for adults with locally advanced recurrent nasopharyngeal carcinoma, a type of cancer that has returned in the nasopharynx area. This Phase 3 randomized controlled trial compares two approaches: surgery combined with both neoadjuvant (before surgery) and adjuvant (after surgery) therapy versus surgery combined with adjuvant therapy alone. The study aims to evaluate outcomes like event-free survival and other effectiveness measures to better understand treatment options. Participants are randomly assigned to one of two groups. The experimental group receives two courses of neoadjuvant therapy, including Toripalimab Injection and Gemcitabine-based chemotherapy, before endoscopic surgery. After surgery, they continue with two to four courses of chemotherapy and eight courses of immunotherapy. The control group undergoes endoscopic surgery first, followed by four to six courses of chemotherapy and ten courses of immunotherapy. Treatments continue until unacceptable side effects occur or planned courses are complete. During the study, participants will undergo assessments such as pathological tumor evaluation two weeks after surgery, imaging evaluations before treatment and surgery, and monitoring for progression, recurrence, and survival up to five years. Researchers will track event-free survival for one year and other secondary outcomes including overall survival, disease-free survival, local and distant recurrence, response rates, and safety. The total participation period extends through treatment and follow-up visits, allowing detailed evaluation of treatment effects and safety.
CONDITIONS
Brief Title
Neoadjuvant vs Adjuvant in Locally Advanced Recurrent NPC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically diagnosed with recurrent nasopharyngeal carcinoma
- Resectable disease staging rT2, rT3 (excluding certain lesions), or rT4 according to AJCC 8th edition
- Cervical lymph node metastasis can be controlled locally
- Aged 18 to 75 years
- Signed informed consent to participate
- No distant metastasis
- At least 6 months since radical radiation to recurrence
- Only one prior course of radiotherapy
- Sufficient organ function
- ECOG performance status 0-2 and able to tolerate surgery, chemotherapy, and immunotherapy
You will not qualify if you...
- Participation in other interventional clinical trials
- Uncontrolled illnesses interfering with therapy
- Another or multiple malignancies within 5 years (except certain treated skin or cervical cancers)
- Any contraindication to surgery
- Serious autoimmune disease
- Current use of immunosuppressive agents or systemic hormone therapy above specified doses
- Severe allergic reactions to monoclonal antibodies
- History of radioactive particle implantation
- Vaccination with live vaccine within 4 weeks before or during the study
- Female patients who are pregnant or breastfeeding
- Other conditions deemed unsuitable by researchers
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of 2 courses of therapy
Participants in the experimental group receive two courses of Toripalimab Injection and chemotherapy before surgery.
Visits corresponding to 2 treatment courses
Duration - Surgery day and immediate recovery period
Participants undergo tumor resection by endoscopic nasopharyngectomy.
1 visit (in-person) for surgery and recovery
Duration - Duration of 2 to 6 courses of chemotherapy and 8 to 10 courses of immunotherapy
Participants receive chemotherapy and Toripalimab Injection after surgery. The experimental group receives 2 to 4 courses of chemotherapy and 8 courses of immunotherapy. The control group receives 4 to 6 courses of chemotherapy and 10 courses of immunotherapy.
Multiple visits corresponding to chemotherapy and immunotherapy courses
Trial Site Locations
Total: 7 locations
1
Eye& ENT Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200031
Actively Recruiting
2
Fujian Medical University Union Hospital
Fuzhou, China
Not Yet Recruiting
3
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, China
Actively Recruiting
4
Changhai Hospital
Shanghai, China
Not Yet Recruiting
5
Shanghai Sixth People's Hospital
Shanghai, China
Not Yet Recruiting
6
Shanghai Zhongshan Hospital
Shanghai, China
Not Yet Recruiting
7
Shenzhen Second People's Hospital
Shenzhen, China
Not Yet Recruiting
Research Team
X
Xiaole Song
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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