Toripalimab Combined With Chemoradiotherapy in Patients With Locoregionally-advanced Nasopharyngeal Carcinoma
1 other identifier
interventional
50
0 countries
N/A
Brief Summary
This is an open-label, parallel controlled, phase IIa exploratory study that evaluates the efficacy and safety of Toripalimab (PD-1 Antibody) combined with induction chemotherapy （Albumin-bound paclitaxel and cisplatin ）and concurrent chemoradiotherapy in the treatment of nasopharyngeal carcinoma and explores the biomarkers that can predict the efficacy and toxicity of the treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2020
Typical duration for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2020
CompletedFirst Posted
Study publicly available on registry
June 25, 2020
CompletedStudy Start
First participant enrolled
July 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2024
CompletedJune 25, 2020
June 1, 2020
3.4 years
June 19, 2020
June 23, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Adverse events
Incidence of adverse events as assessed by CTCAE v5.0
2 years
Secondary Outcomes (5)
Overall survival (OS)
3 years
Distant failure-free survival (DFFS)
3 years
Locoregional failure-free survival (LRFFS)
3 years
Overall response rate （ORR）and Complete response rate（CR）
2 years
Quality of life (QoL)
3 years
Study Arms (2)
Toripalimab+induction chemotherapy +CCRT
EXPERIMENTALPatients 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
induction chemotherapy +CCRT
ACTIVE COMPARATORPatients 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 .
Interventions
Toripalimab 240mg ivdrip, every 3 weeks for 6 cycles, with 3 cycles combined with induction chemotherapy, 3 cycles combined with concurrent chemoradiotherapy
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
Definitive IMRT of ≥66 Gy will be given .
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief Physician
Study Record Dates
First Submitted
June 19, 2020
First Posted
June 25, 2020
Study Start
July 15, 2020
Primary Completion
December 15, 2023
Study Completion
December 15, 2024
Last Updated
June 25, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share