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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
176 participants
INTERVENTIONAL
2024-06-25
2028-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Neoadjuvant vs Adjuvant in Locally Advanced Recurrent NPC
NCT06235203
Phase II Trial of Neoadjuvant and Adjuvant Anti-PD-1 Antibody Toripalimab Combined With CCRT in NPC Patients
NCT03925090
Adding PD-1 Inhibitor to Neoadjuvant and Adjuvant for NPC
NCT04557020
Concurrent Chemoradiotherapy With Toripalimab for Local-regional Recurrent Nasopharyngeal Carcinoma: a Prospective, Single-arm, Phase II Trial
NCT04992988
A Multicenter Trial Comparing Multi-course Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma
NCT00705627
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
The control group
Patients in the control group would go through observation and follow-up after recurrent endoscopic surgery.
No interventions assigned to this group
The experimental group
Patients in the experimental group would be implemented with adjuvant therapy including chemotherapy and immunotherapy after endoscopic surgery.
Immunotherapy,Toripalimab Injection
Patients in the experimental group would be implemented with adjuvant Immunotherapy and chemotherapy after endoscopic surgery. Four to six cycles chemotherapy and 10 cycles immunotherapy,or until unacceptable side effects.
Chemotherapy,Gemcitabine based regimen
Patients in the experimental group would be implemented with adjuvant Immunotherapy and chemotherapy after endoscopic surgery. Four to six cycles chemotherapy and 10 cycles immunotherapy,or until unacceptable side effects.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Immunotherapy,Toripalimab Injection
Patients in the experimental group would be implemented with adjuvant Immunotherapy and chemotherapy after endoscopic surgery. Four to six cycles chemotherapy and 10 cycles immunotherapy,or until unacceptable side effects.
Chemotherapy,Gemcitabine based regimen
Patients in the experimental group would be implemented with adjuvant Immunotherapy and chemotherapy after endoscopic surgery. Four to six cycles chemotherapy and 10 cycles immunotherapy,or until unacceptable side effects.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
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
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hongmeng Yu
Role: PRINCIPAL_INVESTIGATOR
Eye& ENT Hospital, Fudan University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Yuting Lai
Role: CONTACT
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
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
Review additional registry numbers or institutional identifiers associated with this trial.
early-rNPC-RCT-adj
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.