Neoadjuvant vs Adjuvant in Locally Advanced Recurrent NPC
NCT ID: NCT06235203
Last Updated: 2025-06-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
154 participants
INTERVENTIONAL
2024-07-09
2027-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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The control group
Endoscopic surgery + adjuvant therapy
endoscopic surgery
The tumor was resected by endoscopic nasopharyngectomy.
Adjuvant therapy in control group,Toripalimab Injection and Gemcitabine based therapy
Ten courses of Toripalimab Injection and four to six courses of chemotherapy,or until unacceptable side effects.
The experimental group
Neoadjuvant therapy +endoscopic surgery + adjuvant therapy
endoscopic surgery
The tumor was resected by endoscopic nasopharyngectomy.
Neoadjuvant therapy,Toripalimab Injection and Gemcitabine based therapy
Two courses of Toripalimab Injection and two courses of Toripalimab Injection and Gemcitabine based chemotherapy were given before endoscopic surgery.
Adjuvant therapy in experimental group,Toripalimab Injection and Gemcitabine based therapy
Eight courses of Toripalimab Injection and two to four courses of chemotherapy, or until unacceptable side effects.
Interventions
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endoscopic surgery
The tumor was resected by endoscopic nasopharyngectomy.
Neoadjuvant therapy,Toripalimab Injection and Gemcitabine based therapy
Two courses of Toripalimab Injection and two courses of Toripalimab Injection and Gemcitabine based chemotherapy were given before endoscopic surgery.
Adjuvant therapy in experimental group,Toripalimab Injection and Gemcitabine based therapy
Eight courses of Toripalimab Injection and two to four courses of chemotherapy, or until unacceptable side effects.
Adjuvant therapy in control group,Toripalimab Injection and Gemcitabine based therapy
Ten courses of Toripalimab Injection and four to six courses of chemotherapy,or until unacceptable side effects.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
75 Years
ALL
No
Sponsors
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Shanghai Zhongshan Hospital
OTHER
Shanghai 6th People's Hospital
OTHER
Changhai Hospital
OTHER
Fujian Medical University Union Hospital
OTHER
People's Hospital of Guangxi Zhuang Autonomous Region
OTHER
Shenzhen Second People's Hospital
OTHER
Eye & ENT Hospital of Fudan University
OTHER
Responsible Party
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Locations
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Eye& ENT Hospital, Fudan University
Shanghai, Shanghai Municipality, 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
Countries
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Central Contacts
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Facility Contacts
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Desheng Wang
Role: primary
Shenhong Qu
Role: primary
Haihong Tang
Role: primary
Weitian Zhang
Role: primary
Xinsheng Huang
Role: primary
Yongtian Lu
Role: primary
Other Identifiers
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adv-rNPC-RCT-Neo-V1
Identifier Type: -
Identifier Source: org_study_id
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