- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04446663
Toripalimab Combined With Chemoradiotherapy in Patients With Locoregionally-advanced Nasopharyngeal Carcinoma
Toripalimab Combined With Chemoradiotherapy in Locoregionally-advanced Nasopharyngeal Carcinoma: an Open-label, Parallel Controlled, Phase IIa Study
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Guo Yi Zhang, Doctor
- Phone Number: +86-0757-83162735
- Email: guoyizhff@163.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Only the patients meeting all the following criteria can be eligible to participate in the trial:
- Fully understand this study and voluntarily sign the informed consent form (ICF); have good compliance;
- Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III ;
- locoregionally advanced nasopharyngeal carcinoma (LANPC)(T3-4N0-1M0/T1-4N2-3M0);
- Age 18 to 70 years;
- ECOG PS 0-1;
The laboratory examination results before enrollment must meet the following standards:
- Neutrophils ≥1.5 × 109 / L;
- Platelets ≥100 × 109 / L;
- Hemoglobin ≥90g / L (no infusion of concentrated red blood cells within 4 weeks);
- Serum creatinine ≤ 1.5 × ULN and creatinine clearance ≥ 60 mL / min;
- Total serum bilirubin ≤ 1.5 × ULN;
- AST and ALT ≤ 2.5 × ULN;
- The ULN of coagulation parameters APTT is not extended for more than 10 seconds, and the ULN of PT is not extended for more than 3 seconds;
- Women of childbearing age must confirm that the serum pregnancy test is negative and agree to use effective contraception during drug use and within 1 year after the last dose;Men whose female partners have the ability to become pregnant must agree to use reliable contraception within 1 year from the screening visit to the last Toripalimab administration.
Exclusion Criteria:
- Women of child-bearing potential are pregnant or breastfeeding ;
- Have known allergy to large molecule protein products or any compound of Toripalimab;
- Central nervous system metastases with clinical symptoms accompanied by cerebral edema, requiring hormone intervention, or progression of brain metastases;
- Prior malignancy within 5 years, except carcinoma in situ of the cervix, adequately treated basal cell carcinoma of the skin and papillary thyroid carcinoma;
Received any of the following treatments:
- Patients who have been treated with inhibitors of immune regulation (CTLA-4, PD-1, PD-L1, etc.);
- Received any research drug within 4 weeks before the first administration of the drug;
- Join another clinical study at the same time, unless it is an observational (non-interventional) study or intervention study during follow-up;
- Within 28 days before signing the informed consent, received an equivalent dose of >10 mg prednisone/day or other immunosuppressive therapy, and a systemic hormone dose of ≤10 mg prednisone/day or inhaled/topical corticosteroids;
- Have been vaccinated with anti-tumor vaccines or have been vaccinated with live vaccines within 4 weeks before the first administration of study drugs;
- Have undergone major surgery or severe trauma within 4 weeks before the first administration of study drugs;
- Uncontrolled clinical symptoms or diseases of the heart, such as: (1) Heart failure above NYHA level II (2) Unstable angina (3) Myocardial infarction occurred within 1 year (4) Clinically supraventricular or Patients with ventricular arrhythmias requiring clinical intervention;
- Serious infections (CTCAE>2) within 4 weeks before the first use of the study drug, such as severe pneumonia, bacteremia, and infection comorbidities that require hospitalization; baseline chest imaging examinations suggest active lung inflammation . The symptoms and signs of infection exist within 2 weeks before the first dose or require oral or intravenous antibiotic use (excluding prophylactic antibiotic use);
- Have a history of interstitial lung disease and non-infectious pneumonia;
- Have active tuberculosis infection, or have a history of active tuberculosis infection within 1 year before enrollment, or have active tuberculosis infection one year ago but have not been formally treated;
- Have active autoimmune diseases or a history of autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to These diseases and syndromes); Autoimmune-mediated hypothyroidism treated with stable doses of thyroid replacement hormone; Type I diabetes with stabilized doses of insulin; but excluding vitiligo or cured childhood asthma/allergy who do not require any intervention in adults;
- A history of HIV infection, or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation and bone marrow transplantation;
- Have active hepatitis HBsAg positive and HBV DNA ≥2000IU/ml or 1000 copies/ml, hepatitis C (hepatitis C antibody positive, and HCV-RNA is higher than the detection limit);
- Known history of psychotropic substance abuse, alcoholism and drug abuse;
- Any other disease or condition of clinical significance that the investigator believes may affect protocol compliance, or affect the signing of an ICF, or is not suitable for participation in this clinical trial.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Toripalimab+induction chemotherapy +CCRT
Patients will receive induction chemotherapy with Albumin-bound paclitaxel (260 mg/m2, d1 of every cycle) and cisplatin (80mg/m2, d1 of every cycle), every 3 weeks for 3 cycles before radiotherapy. Then patients will receive definitive intensity-modulated radiotherapy (IMRT) of ≥66 Gy(2-2.2Gy/fx).Concurrent cisplatin of 100mg/m2 will be administered every 3 weeks for 2 cycles during IMRT . Toripalimab 240mg will be given every 3 weeks for 6 cycles, started on day 1 of induction chemotherapy |
Toripalimab 240mg ivdrip, every 3 weeks for 6 cycles, with 3 cycles combined with induction chemotherapy, 3 cycles combined with concurrent chemoradiotherapy
Other Names:
Albumin-bound Paclitaxel 260 mg/m2, d1 of every cycle, every 3 weeks for 3 cycles before radiotherapy
Induction cisplatin 80mg/m2, every 3 weeks for 3 cycles before radiotherapy Concurrent cisplatin 100mg/m2, every 3 weeks for 2 cycles during radiotherapy
Other Names:
Definitive IMRT of ≥66 Gy will be given .
Other Names:
|
Active Comparator: induction chemotherapy +CCRT
Patients will receive induction chemotherapy with Albumin-bound paclitaxel (260 mg/m2, d1 of every cycle) and cisplatin (80mg/m2, d1 of every cycle), every 3 weeks for 3 cycles before radiotherapy. Then patients will receive definitive intensity-modulated radiotherapy (IMRT) of ≥66 Gy(2-2.2Gy/fx).Concurrent cisplatin of 100mg/m2 will be administered every 3 weeks for 2 cycles during IMRT . |
Albumin-bound Paclitaxel 260 mg/m2, d1 of every cycle, every 3 weeks for 3 cycles before radiotherapy
Induction cisplatin 80mg/m2, every 3 weeks for 3 cycles before radiotherapy Concurrent cisplatin 100mg/m2, every 3 weeks for 2 cycles during radiotherapy
Other Names:
Definitive IMRT of ≥66 Gy will be given .
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse events
Time Frame: 2 years
|
Incidence of adverse events as assessed by CTCAE v5.0
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival (OS)
Time Frame: 3 years
|
calculated from randomization to the date of death from any cause.
|
3 years
|
Distant failure-free survival (DFFS)
Time Frame: 3 years
|
calculated from randomization to the date of first distant metastasis.
|
3 years
|
Locoregional failure-free survival (LRFFS)
Time Frame: 3 years
|
calculated from randomization to the date of locoregional persistence or 1st locoregional recurrence
|
3 years
|
Overall response rate (ORR)and Complete response rate(CR)
Time Frame: 2 years
|
Defined as percentage of participants achieving complete response (CR) and partial response (PR) according to the RECIST 1.1.
|
2 years
|
Quality of life (QoL)
Time Frame: 3 years
|
The change of QoL from randomization to 12 months after chemoradiation.
The European Organization for Research and Treatment of Cancer quality of life questionnaire-C30 (EORTC QLQ-C30)version 3.0 will be used.
This questionnaire comprises 30 questions, 24 of which are aggregated into nine multi-question scales, that is, five functioning scales (e.g., physical), three symptom scales (e.g., fatigue) and one global health status scale.
The remaining six single-question (e.g., dyspnoea) scales assess symptoms.
These 15 scales will be scored according to the official Scoring Manual: 1. Estimate the average of the questions that contribute to the scale; this is the raw score.
2. Use a linear transformation to standardise the raw score, so that scores range from 0 to 100.
Thus, a high score for a functional scale represents a high level of functioning, a high score for the global health status represents a high QoL, but a high score for a symptom scale represents a high level of problems.
|
3 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Nasopharyngeal Carcinoma
- Nasopharyngeal Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
- Albumin-Bound Paclitaxel
Other Study ID Numbers
- JS001-ISS-CO185
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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