Neoadjuvant vs Adjuvant in Locally Advanced Recurrent NPC

Official title

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

Overview

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

Detailed 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.

Interventions

• 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.
• Drug 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.
• Drug 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.

Primary outcome measures

• EFS [Time frame: 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 outcome measures (10)

• OS [Time frame: Time interval of randomization and death of any cause, up to 5 years]
• DFS [Time frame: From randomization to recurrence, metastasis or death, up to 1 year]
• LRFS [Time frame: From randomization to local recurrence or death, up to 1 year]
• DMFS [Time frame: From randomization to distant metastasis or death, up to 1 year]
• pCR [Time frame: Time point of pathological tumor evaluation after sugery, around 2 weeks after sugery]
• ORR [Time frame: Time point of imaging evaluation before treatment(or randomization) and before surgery,up to 1 year]
• DCR [Time frame: Time point of imaging evaluation before treatment(or randomization) and before surgery,up to 1 year]
• DoR [Time frame: First date of response to the date of progression, up to 5 years]
• 1-and 2-year PFS rate [Time frame: one- and two-year]
• 1-and 2-year OS rate [Time frame: one- and two-year]

Eligibility criteria

Inclusion criteria

• Pathologically diagnosed with recurrent nasopharyngeal carcinoma;
• 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;
• Cervical lymph node metastasis can be controlled locally;
• Aged 18 to 75 years;
• Informed consent forms signed to participate in the trial;
• Without distant metastasis;
• ≥6months from the accomplishment of radical radiation to recurrence
• previously only 1 course of radiotherapy;
• Sufficient organ function;
• ECOG score 0-2 and can tolerate surgery,chemotherapy and immunotherapy.

Exclusion criteria

• Participate in other interventional clinical trials;
• Uncontrolled illnesses that interfere with the therapy;
• Suffering from another or multiple malignancy within 5 years (excluding fully treated basal cell or skin squamous cell carcinoma, cervical carcinoma in situ, etc.);
• Any contradiction to surgery;
• With serious autoimmune disease;
• 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;
• Severe allergic reactions to other monoclonal antibodies;
• History of radioactive particle planting;
• Vaccination with live vaccine within 4 weeks prior to initial administration or possibly during the study period;
• Female patients who are at pregnancy or lactation;
• Other situations that the researchers believe not suitable for enrollment

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

China · 7 centers

• Eye& ENT Hospital, Fudan University — Shanghai
• Fujian Medical University Union Hospital — Fuzhou
• The People's Hospital of Guangxi Zhuang Autonomous Region — Nanning
• Changhai Hospital — Shanghai
• Shanghai Sixth People's Hospital — Shanghai
• Shanghai Zhongshan Hospital — Shanghai
• Shenzhen Second People's Hospital — Shenzhen

Identifiers

NCT: NCT06235203 · adv-rNPC-RCT-Neo-V1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗