Adjuvant vs Surgery Only in Early-stage Recurrent NPC

Recurrent Nasopharyngeal Carcinoma Clinical Trial

Official title:

Adjuvant Therapy Versus Endoscopic Surgery Alone in Early-stage Recurrent Nasopharyngeal Carcinoma: A Multicenter Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06228079
• Other study ID #: early-rNPC-RCT-adj
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: February 1, 2024
• Est. completion date: June 30, 2028

Study information

• Verified date: January 2024
• Source: Eye & ENT Hospital of Fudan University
• Contact: Xiaole Song, MD
• Phone: +8621 64377134
• Email: jxfxsxl[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Adjuvant Therapy Versus Endoscopic Surgery Alone in Early-stage Recurrent Nasopharyngeal Carcinoma: A Multicenter Randomized Controlled Trial

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 176
• Est. completion date: June 30, 2028
• Est. primary completion date: June 30, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma
• Recurrence
• Recurrent Nasopharyngeal Carcinoma

Intervention

Drug:
• 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.

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	DFS	Disease free survival	From date of randomization until the date of first documented recurrence, metastasis or date of death from any cause, whichever came first, assessed up to 24 months
Secondary	OS	Overall Survival	From randomization to death of any cause,assessed up to 60 months
Secondary	LRFS	Local recurrence free survival	From randomization to local recurrence or death,assessed up to 24 months
Secondary	DMFS	Distant metastasis free survival	From randomization to distant metastasis or death, assessed up to 24 months
Secondary	1-and 2-year DFS rate	one- and two-year disease free survival	end of 1st year, end of 2nd year
Secondary	1-and 2-year OS rate	one- and two-year overall survival rate	end of 1st year, end of 2nd year