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Compares treatment options for Recurrent Nasopharyngeal Carcinoma
Official title Neoadjuvant vs Adjuvant in Locally Advanced Recurrent NPC
ClinicalTrials.gov ID: NCT06235203
What this study is testing
What is Neoadjuvant therapy,Toripalimab Injection and Gemcitabine based therapy?
Neoadjuvant therapy,Toripalimab Injection and Gemcitabine based therapy is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for recurrent nasopharyngeal carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- Cervical lymph node metastasis can be controlled locally;
- Aged 18 to 75 years;
- Informed consent forms signed to participate in the trial;
You likely can't join if
- Participate in other treatment 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...
- 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...
See the full eligibility 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.
- Participate in other treatment 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
- Fuzhou, China
- Nanning, China
- Shanghai, China
- Shenzhen, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China; Fuzhou, China; Nanning, China; Shanghai, China; Shenzhen, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.