Neoadjuvant vs Adjuvant in Locally Advanced Recurrent NPC

Recurrent Nasopharyngeal Carcinoma Clinical Trial

Official title:

Neoadjuvant-Adjuvant Versus Adjuvant-Only Therapy Combined With Endoscopic Surgery in Advanced Recurrent Nasopharyngeal Carcinoma:A Multicenter Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06235203
• Other study ID #: adv-rNPC-RCT-Neo-V1
• Status: Recruiting
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma
• Recurrence
• Recurrent Nasopharyngeal Carcinoma

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