Trial Title:
Neoadjuvant vs Adjuvant in Locally Advanced Recurrent NPC
NCT ID:
NCT06235203
Condition:
Recurrent Nasopharyngeal Carcinoma
Conditions: Official terms:
Carcinoma
Nasopharyngeal Carcinoma
Recurrence
Gemcitabine
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Procedure
Intervention name:
endoscopic surgery
Description:
The tumor was resected by endoscopic nasopharyngectomy.
Arm group label:
The control group
Arm group label:
The experimental group
Intervention type:
Drug
Intervention name:
Neoadjuvant therapy,Toripalimab Injection and Gemcitabine based therapy
Description:
Two courses of Toripalimab Injection and two courses of Toripalimab Injection and
Gemcitabine based chemotherapy were given before endoscopic surgery.
Arm group label:
The experimental group
Intervention type:
Drug
Intervention name:
Adjuvant therapy in experimental group,Toripalimab Injection and Gemcitabine based therapy
Description:
Eight courses of Toripalimab Injection and two to four courses of chemotherapy, or until
unacceptable side effects.
Arm group label:
The experimental group
Intervention type:
Drug
Intervention name:
Adjuvant therapy in control group,Toripalimab Injection and Gemcitabine based therapy
Description:
Ten courses of Toripalimab Injection and four to six courses of chemotherapy,or until
unacceptable side effects.
Arm group label:
The control group
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.
Criteria for eligibility:
Criteria:
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 70 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. Previously received treatment with PD-1 monoclonal antibody, PD-L1 monoclonal
antibody, CTLA-4 monoclonal antibody (or any other antibody acting on T cell
co-stimulation or checkpoint pathway);
9. History of radioactive particle planting;
10. Vaccination with live vaccine within 4 weeks prior to initial administration or
possibly during the study period;
11. Female patients who are at pregnancy or lactation;
12. Other situations that the researchers believe not suitable for enrollment
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Eye& ENT Hospital, Fudan University
Address:
City:
Shanghai
Zip:
200031
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaole Song
Phone:
15821388769
Email:
jxfxsxl@163.com
Investigator:
Last name:
Hongmeng Yu
Email:
Principal Investigator
Investigator:
Last name:
Xiaole Song
Email:
Sub-Investigator
Investigator:
Last name:
Li Yan
Email:
Sub-Investigator
Investigator:
Last name:
Yuting Lai
Email:
Sub-Investigator
Facility:
Name:
Fujian Medical University Union Hospital
Address:
City:
Fuzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Desheng Wang
Investigator:
Last name:
Desheng Wang
Email:
Principal Investigator
Investigator:
Last name:
Haichun Lai
Email:
Sub-Investigator
Facility:
Name:
The People's Hospital of Guangxi Zhuang Autonomous Region
Address:
City:
Nanning
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Shenhong Qu
Investigator:
Last name:
Shenhong Qu
Email:
Principal Investigator
Investigator:
Last name:
Jingjin Weng
Email:
Sub-Investigator
Facility:
Name:
Changhai Hospital
Address:
City:
Shanghai
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Haihong Tang
Investigator:
Last name:
Haihong Tang
Email:
Principal Investigator
Investigator:
Last name:
Hongliang Zheng
Email:
Sub-Investigator
Investigator:
Last name:
Haopu Li
Email:
Sub-Investigator
Investigator:
Last name:
Fengya Pan
Email:
Sub-Investigator
Facility:
Name:
Shanghai Sixth People's Hospital
Address:
City:
Shanghai
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Weitian Zhang
Investigator:
Last name:
Weitian Zhang
Email:
Principal Investigator
Investigator:
Last name:
Ru Tang
Email:
Sub-Investigator
Facility:
Name:
Shanghai Zhongshan Hospital
Address:
City:
Shanghai
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xinsheng Huang
Investigator:
Last name:
Xinsheng Huang
Email:
Principal Investigator
Investigator:
Last name:
Xianhui Ning
Email:
Principal Investigator
Investigator:
Last name:
Lei Zhou
Email:
Principal Investigator
Facility:
Name:
Shenzhen Second People's Hospital
Address:
City:
Shenzhen
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yongtian Lu
Investigator:
Last name:
Yongtian Lu
Email:
Principal Investigator
Investigator:
Last name:
Jing Tao
Email:
Principal Investigator
Start date:
May 1, 2024
Completion date:
June 30, 2027
Lead sponsor:
Agency:
Eye & ENT Hospital of Fudan University
Agency class:
Other
Collaborator:
Agency:
Shanghai Zhongshan Hospital
Agency class:
Other
Collaborator:
Agency:
Shanghai 6th People's Hospital
Agency class:
Other
Collaborator:
Agency:
Changhai Hospital
Agency class:
Other
Collaborator:
Agency:
Fujian Medical University Union Hospital
Agency class:
Other
Collaborator:
Agency:
People's Hospital of Guangxi
Agency class:
Other
Collaborator:
Agency:
Shenzhen Second People's Hospital
Agency class:
Other
Source:
Eye & ENT Hospital of Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06235203
