Phase Ⅱ Trial of Neoadjuvant Chemotherapy Combined With Camrelizumab Followed by Chemoradiotherapy in Patients Without Distant Metastasis Nasopharyngeal Carcinoma

Tianjin Medical University Cancer Institute and Hospital1 site in 1 country59 target enrollmentMarch 20, 2021

ConditionsDisease-free Survival Rate

InterventionsCamrelizumab+Chemotherapy+Chemoradiotherapy

DrugsCamrelizumab+Chemotherapy+Chemoradiotherapy

Overview

Phase: Phase 2
Intervention: Camrelizumab+Chemotherapy+Chemoradiotherapy
Conditions: Disease-free Survival Rate
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Enrollment: 59
Locations: 1
Primary Endpoint: Disease-free survival（DFS）rate of 3 years
Status: Recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

To see the effect if a combination of neoadjuvant chemotherapy combined with Camrelizumab followed by chemoradiotherapy in treating patients without distant metastasis nasopharyngeal carcinoma

Detailed Description

The primary objective of this phase 2 study is to assess disease-free survival rate of 3 years in patients with NPC. The secondary objective is to observe objective response rate, progression free survival, overall survival and safety

Registry

clinicaltrials.gov

Start Date

March 20, 2021

End Date

March 20, 2025

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Responsible Party

Principal Investigator

Peiguo Wang

Chief Physician

Tianjin Medical University Cancer Institute and Hospital

Eligibility Criteria

Inclusion Criteria

•Sign written informed consent before enrollment;
•Male or female under the age of 70;
•Diagnosed by imaging examination and histopathologic examination Ⅱ I - Ⅳ b period in patients with nasopharyngeal carcinoma
•No first-line treatment has been received
•ECOG/PS score: 0 \~ 1;
•Expected survival is greater than 12 weeks;
•The function of vital organs meets the following requirements (excluding the use of any blood components and cell growth factors within 14 days) :
•Routine blood examination (no blood transfusion or use of hematopoietic stimulant subclass drugs to correct within 14 days before screening) Hemoglobin (Hb) ≥90 g/L; Absolute neutrophil count (ANC) ≥1.5×109/L; Absolute value of lymphocyte count (LC) ≥0.5×109/L; Platelet count (PLT) ≥100×109/L; White blood cell count (WBC) ≥4.0×109/L and ≤15×109/L;
•Biochemistry (no blood transfusion or albumin within 14 days prior to screening) AST and ALT ≤2.5 x ULN ALP ≤ 2.5 x ULN TBiL≤ 1.5 x ULN ALB≥30 g/L; Cr≤1.5×ULN, and creatinine clearance rate (CrCl)≥80 mL/min (Cockcroft-Gault formula)
•Normal coagulation function, no active bleeding and thrombotic disease A. International standardized ratio INR≤1.5×ULN; B. Partial thromboplastin time APTT≤1.5×ULN; C. Prothrombin time Pt ≤1.5×ULN;

Exclusion Criteria

•Previous radiation, chemotherapy, hormone therapy, surgery, or molecular targeted therapy;
•Imaging confirmed patients with distant metastasis;
•Subjects have previous or co-existing malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
•Previous treatment with carrelizumab or other PD-1/PD-L1 inhibitors was not included;Subject is known to have a prior allergy to macromolecular protein formulations or to any of the carrizumab or chemotherapy ingredients used by the subject during neoadjuvant therapy;
•there is no active participants autoimmune disease or a history of autoimmune diseases (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, the pituitary gland inflammation, vasculitis, nephritis, thyroid function, thyroid function is reduced, always had thyroid surgery must be incorporated into;Subjects with vitiligo or asthma that had been in complete remission during childhood were enrolled as adults without any intervention;Asthmatic subjects requiring bronchodilators for medical intervention were not included);
•Subjects are using immunosuppressants and continue to use them within 2 weeks before enrolment;
•Patients with clinical cardiac symptoms or diseases that are not well controlled, such as :(1) NYHA2 heart failure or above, (2) unstable angina, (3) myocardial infarction within 1 year, (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention;
•Abnormal coagulation function (PT\>16 s, APTT\>43S, TT\>21 s, Fbg\>2g/L) with bleeding tendency or undergoing thrombolytic or anticoagulant therapy;
•Previous or current severe bleeding (bleeding within 3 months \>30 ml), hemoptysis (within 4 weeks \>5 ml fresh blood) or thromboembolic events (including stroke events and/or transient ischemic attack) within 12 months;
•Subjects were still using TCM immunomodulator 2 weeks before enrollment;

Arms & Interventions

Camrelizumab+Chemotherapy+Chemoradiotherapy

Patients received neoadjuvant Camrelizumab 200mg combined with chemotherapy (Cisplatin 20mg/m2, Day 1-3, Docetaxel 75mg/m2, Day 1) for 2 cycles every 21 days, followed by concurrent chemoradiotherapy with Camrelizumab monotherapy maintenance

Intervention: Camrelizumab+Chemotherapy+Chemoradiotherapy

Outcomes

Primary Outcomes

Disease-free survival（DFS）rate of 3 years

Time Frame: 3 years

Disease-free survival is calculated from the date of randomization to the date of the first progress at any site or death from any cause or censored at the date of the last follow-up.

Secondary Outcomes

Overall response rate(16 weeks after completion of concurrent chemoradiotherapy)
Incidence of adverse events(3 years)
Overall survival(OS)(3 years)
Distant metastasis-free survival(DMFS) rate of 3 years(3 years)