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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06235203
Other study ID # adv-rNPC-RCT-Neo-V1
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date May 1, 2024
Est. completion date June 30, 2027

Study information

Verified date June 2024
Source Eye & ENT Hospital of Fudan University
Contact Xiaole Song
Phone +8621 64377134
Email jxfxsxl@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 154
Est. completion date June 30, 2027
Est. primary completion date June 30, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
endoscopic surgery
The tumor was resected by endoscopic nasopharyngectomy.
Drug:
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.

Locations

Country Name City State
China Fujian Medical University Union Hospital Fuzhou
China The People's Hospital of Guangxi Zhuang Autonomous Region Nanning
China Changhai Hospital Shanghai
China Eye& ENT Hospital, Fudan University Shanghai Shanghai
China Shanghai Sixth People's Hospital Shanghai
China Shanghai Zhongshan Hospital Shanghai
China Shenzhen Second People's Hospital Shenzhen

Sponsors (7)

Lead Sponsor Collaborator
Eye & ENT Hospital of Fudan University Changhai Hospital, Fujian Medical University Union Hospital, People's Hospital of Guangxi, Shanghai 6th People's Hospital, Shanghai Zhongshan Hospital, Shenzhen Second People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary EFS Event free survival From randomization and any events(like:progression or toxic effects precluding surgery;inability to resect all gross disease; progression;surgical complications precluding initiation of adjuvant therapy; recurrence;death) up to 1 year
Secondary OS Overall Survival Time interval of randomization and death of any cause, up to 5 years
Secondary DFS Disease free survival From randomization to recurrence, metastasis or death, up to 1 year
Secondary LRFS Local recurrence free survival From randomization to local recurrence or death, up to 1 year
Secondary DMFS Distant metastasis free survival From randomization to distant metastasis or death, up to 1 year
Secondary pCR pathologic complete response Time point of pathological tumor evaluation after sugery, around 2 weeks after sugery
Secondary ORR Objective response rate,Proportion of CR, PR in all patients. Time point of imaging evaluation before treatment(or randomization) and before surgery,up to 1 year
Secondary DCR Disease Control Rate,Proportion of CR, PR and SD in all patients. Time point of imaging evaluation before treatment(or randomization) and before surgery,up to 1 year
Secondary DoR Duration of response,the time from the first assessment of the tumour as CR or PR to the first assessment of PD or death from any cause (whichever event occurs first). First date of response to the date of progression, up to 5 years
Secondary 1-and 2-year PFS rate one- and two-year progression free survival rate one- and two-year
Secondary 1-and 2-year OS rate one- and two-year overall survival rate one- and two-year
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