TN Induction and Adjuvant Therapy for Resectable Local Recurrent Nasopharyngeal Carcinoma
Toripalimab Combined With Nimotuzumab Induction and Adjuvant Therapy for Resectable Local Recurrent Nasopharyngeal Carcinoma：A Single-arm, Phase II Clinical Tria
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Guangdong
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Guangzhou, Guangdong, China, 510060
- Recruiting
- Sun Yat-sen University Cancer Center
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Contact:
- Hua-Yi Jun, Phd
- Phone Number: 18820019088
- Email: huayj@sysucc.org.cn
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 1. Voluntarily participate in and sign the informed consent in person. 2. Aged 18-65 years, male or non-pregnant female. 3. Histologically and/or cytologically confirmed recurrent nasopharyngeal carcinoma (keratinized or non-keratinized carcinoma; Differentiated or undifferentiated) 4. Patients with recurrence time more than 6 months from the end of radiotherapy; 5. Recurrent nasopharyngeal carcinoma that can be resectable: rT1, rT2 (the tumor is confined to the surface of the parapharyngeal space, and the distance from the internal carotid artery is greater than that from the internal carotid artery 0.5cm), rT3 (confined to the floor wall of the sphenoid sinus, greater than 0.5cm from the internal carotid artery/cavernous sinus) (AJCC 8th stage).
If the tumor invades the internal carotid artery, or is less than 0.5cm away from the internal carotid artery, but the invasion scope does not exceed the external edge of the internal carotid artery, it can be advanced Internal carotid artery preconditioning (including internal carotid artery embolization or stent implantation) was followed.
6. ECOG score 0-1, no serious dysfunction of heart, lung, liver, kidney and other vital organs.
7. Hemoglobin (HGB) ≥90 g/L, white blood cells (WBC) ≥4.0×109 /L, platelets (PLT) ≥100×109 /L.
8. Liver function: ALT and AST< 2.5 times the upper limit of normal (ULN), total bilirubin <2.0×ULN.
9. Renal function: serum creatinine <1.5×ULN.
Exclusion Criteria:
1. The pathological findings were keratinized squamous cell carcinoma (WHO type I).
2. Received systemic or local glucocorticoid therapy within 4 weeks before enrollment.
3. Patients who have participated in other drug clinical trials within 3 months before treatment.
4. Patients with a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 5. Idiopathic pulmonary fibrosis, drug-induced pneumonia, institutional pneumonia (i.e., bronchiolitis obliterans), clinical symptoms or Radiation pneumonia, active pneumonia, or other moderate to severe lung disease requiring steroid treatment 6. Have a comorbiditis that requires prolonged treatment with immunosuppressive drugs or systemic or local use of immunosuppressive doses of corticosteroids.
7. The subject has any active autoimmune disease or history of autoimmune disease (including, but not limited to, interstitial disease) Pneumonia, uveitis, enteritis, hepatitis, pituitaritis, nephritis, hyperthyroidism, hypothyroidism; Suffer from Patients with vitiligo or asthma that had completely resolved in childhood and did not require any intervention in adulthood were included; Need bronchus Dilators for medical intervention in asthma were not included).
8. Positive HBV DNA copy number was detected in both HIV-positive and HBsAg positive patients (quantitative detection ≥ 1000cps/ml); Chronic hepatitis C blood screening positive (HCV antibody positive) with HCV RNA positive detection.
9. Received any anti-infection vaccine (such as influenza vaccine, chickenpox vaccine, etc.) within 4 weeks before enrollment.
10. Pregnancy test positive women of childbearing age and breastfeeding women. 11. Patients who cannot cooperate with regular follow-up due to psychological, social, family and geographical reasons.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental group
Toripalimab Combined With Nimotuzumab Induction therapy then surgery and Toripalimab Combined With Nimotuzumab adjuvant Therapy
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Triplizumab (240mg, Q3W, 2 cycles, induction)and (240mg, Q3W, 15 cycles, adjuvant)
Triplizumab (200mg, Q3W, 2 cycles, induction) and (200mg, Q3W, 15 cycles, adjuvant)
The complete resection of the nasopharyngeal tumor and its adequate safety boundary must be performed under general anesthesia and under the guidance of nasal endoscopy through bilateral nasal passages.
The anterior incisal margin should reach 1-2cm in front of the posterior column of the nasal septum, and the upper incisal margin should reach about 0.5-1cm in front of the upper margin of the posterior nostril.
The lateral incisal margin and the lower incisal margin should be individually designed according to the size and location of the tumor.
A safe incisal margin of 0.5-1.0cm
was obtained, and then the tumor tissue and normal tissue of the incisal margin were ablated layer by layer from the upper incisal margin to the lower incisal margin until no obvious tumor remained under the naked eye.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
2-year progression-free survival
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years.
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2-year progression-free survival
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From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Stomatognathic Diseases
- Neoplasms by Site
- Neoplasms
- Neoplasms by Histologic Type
- Head and Neck Neoplasms
- Neoplasms, Glandular and Epithelial
- Otorhinolaryngologic Diseases
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Nasopharyngeal Neoplasms
- Nasopharyngeal Carcinoma
- Carcinoma
- Antineoplastic Agents, Immunological
- Antineoplastic Agents
- Nimotuzumab
Other Study ID Numbers
- 2024-FXY-320-NPC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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