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Neoadjuvant vs Adjuvant in Locally Advanced Recurrent NPC

ConditionRecurrent Nasopharyngeal Carcinoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorEye & ENT Hospital of Fudan University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • endoscopic surgery

    Procedure/Surgery

    The tumor was resected by endoscopic nasopharyngectomy.

  • Neoadjuvant therapy,Toripalimab Injection and Gemcitabine based therapy

    Drug

    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

    Drug

    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

    Drug

    Ten courses of Toripalimab Injection and four to six courses of chemotherapy,or until unacceptable side effects.

Treatment groups

154 Participants
are divided into 2 treatment groups
Group A: The control groupActive comparator 2 interventions
Group B: The experimental groupExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

EFS

Event free survival

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 outcomes

1

OS

Overall Survival

Time frame
Time interval of randomization and death of any cause, up to 5 years
2

DFS

Disease free survival

Time frame
From randomization to recurrence, metastasis or death, up to 1 year
3

LRFS

Local recurrence free survival

Time frame
From randomization to local recurrence or death, up to 1 year
4

DMFS

Distant metastasis free survival

Time frame
From randomization to distant metastasis or death, up to 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eye & ENT Hospital of Fudan University

Lead sponsor

Shanghai Zhongshan Hospital

Collaborator

Shanghai 6th People's Hospital

Collaborator

Changhai Hospital

Collaborator

Fujian Medical University Union Hospital

Collaborator

People's Hospital of Guangxi Zhuang Autonomous Region

Collaborator

Shenzhen Second People's Hospital

Collaborator

Source ClinicalTrials.gov
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