Neoadjuvant vs Adjuvant in Locally Advanced Recurrent NPC

Eye & ENT Hospital of Fudan University

Status and phase: Enrolling; Phase 3

Conditions: Recurrent Nasopharyngeal Carcinoma

Treatments: Drug: Adjuvant therapy in experimental group,Toripalimab Injection and Gemcitabine based therapy; Drug: Neoadjuvant therapy,Toripalimab Injection and Gemcitabine based therapy; Drug: Adjuvant therapy in control group,Toripalimab Injection and Gemcitabine based therapy; Procedure: endoscopic surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT06235203

adv-rNPC-RCT-Neo-V1

Details and patient eligibility

About

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

Full 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.

Enrollment: 154 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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 75 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. History of radioactive particle planting;
9. Vaccination with live vaccine within 4 weeks prior to initial administration or possibly during the study period;
10. Female patients who are at pregnancy or lactation;
11. Other situations that the researchers believe not suitable for enrollment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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154 participants in 2 patient groups

The control group

Active Comparator group

Description:

Endoscopic surgery + adjuvant therapy

Treatment:

Procedure: endoscopic surgery

Drug: Adjuvant therapy in control group,Toripalimab Injection and Gemcitabine based therapy

The experimental group

Experimental group

Description:

Neoadjuvant therapy +endoscopic surgery + adjuvant therapy

Treatment:

Procedure: endoscopic surgery

Drug: Neoadjuvant therapy,Toripalimab Injection and Gemcitabine based therapy

Drug: Adjuvant therapy in experimental group,Toripalimab Injection and Gemcitabine based therapy