Trial Title:
Adjuvant vs Surgery Only in Early-stage Recurrent NPC
NCT ID:
NCT06228079
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:
Drug
Intervention name:
Immunotherapy,Toripalimab Injection
Description:
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.
Arm group label:
The experimental group
Intervention type:
Drug
Intervention name:
Chemotherapy,Gemcitabine based regimen
Description:
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.
Arm group label:
The experimental group
Summary:
Adjuvant Therapy Versus Endoscopic Surgery Alone in Early-stage Recurrent Nasopharyngeal
Carcinoma: A Multicenter Randomized Controlled Trial
Detailed description:
This study is an open-label, multicentered, evaluator-blinded , randomized clinical
trial.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Pathologically diagnosed with recurrent nasopharyngeal carcinoma;
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 70 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:
1. Participation in other interventional clinical trials;
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. Previously 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 are 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:
June 25, 2024
Completion date:
June 30, 2028
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/NCT06228079
