An Open-Label, Phase Ⅱ Study of Toripalimab and Anlotinib Combination Treatment in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma After Failure of at Least One Line of Platinum-Based Chemotherapy (TORAL)

Sun Yat-sen University1 site in 1 country40 target enrollmentOctober 30, 2021

ConditionsNasopharyngeal Carcinoma Recurrent or Metastatic Nasopharyngeal Carcinoma

InterventionsToripalimab and Anlotinib

Overview

Phase: Phase 2
Intervention: Toripalimab and Anlotinib
Conditions: Nasopharyngeal Carcinoma
Sponsor: Sun Yat-sen University
Enrollment: 40
Locations: 1
Primary Endpoint: Objective Response rate
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This phase 2 trial studies toripalimab and anlotinib combination treatment in patients with recurrent or metastatic nasopharyngeal carcinoma after failure of at least one line of platinum-based chemotherapy

Registry

clinicaltrials.gov

Start Date

October 30, 2021

End Date

December 1, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sun Yat-sen University

Responsible Party

Principal Investigator

Qingqing Cai

Chief physician

Sun Yat-sen University

Eligibility Criteria

Inclusion Criteria

•Histologically confirmed undifferentiated non-keratinizing carcinoma
•Patients suffered failure of at least one line of platinum-based chemotherapy. The definition of treatment failure: progression during or after chemotherapy for recurrence/metastasis; progression after concurrent chemoradiotherapy within 6 months. Withdrawal of treatment due to drug intolerances is excluded ;
•Without other malignancy;
•Male or female, 18-70 years;
•Eastern Cooperative Oncology Group (ECOG) of 0-2;
•Life expectancy ≥ 3 months;
•Women of childbearing age must obtain the negative result of a pregnancy test (serum or urine) , and they were willing to use reliable methods of contraception during the trial;
•At least one evaluable lesion；
•Laboratory tests meet the following standards:
•Blood routine: White blood cell count (WBC) ≥3.0×10 9 /L, neutrophil count (ANC) ≥1.5×10 9 /L, platelet count (PLT) ≥75×10 9 /L, hemoglobin (HGB) 90 g/L or higher; Liver function: total bilirubin ≤1.5 times the upper limit of normal (ULN); glutamic-oxalacetic transaminase (AST) and alanine transaminase (ALT) ≤2.5 times ULN, AST and ALT ≤2.5 times ULN for the patients with liver metastases; Alkaline phosphatase ≤5 times ULN; Renal function: Serum creatinine (Cr) ≤1.5 times ULN; Creatinine clearance ≥60mL/min; Urine routine: urine protein \<2+ ;baseline urine protein ≥2+ and 24 hours urine protein \< 1g ; Coagulation: International normalized ratio (INR) and activated partial thrombin time (APTT) ≤1.5 times ULN; Albumin ≥28g/L Thyroid stimulating hormone (TSH)≤1 times ULN (free triiodothyrosine \[FT3\] or free thyroxine \[FT4\] ≤1 times ULN can be included)

Exclusion Criteria

•A known allergy to any of the drugs in the study;
•Pregnant or breastfeeding women;
•Participated in clinical trials of other drugs within 4 weeks prior to study initiation;
•Previous treatment with bevacizumab or VEGFR-family small molecule tyrosine kinase inhibitors (e.g., famitinib, sorafenib, Sunitinib, regofinib, Apatinib, Anlotinib, fuquinitinib) ;
•Recurrent nasopharyngeal lesions after radiotherapy and who received secondary radiotherapy;
•Palliative radiotherapy for symptom control within 28 days before enrollment;
•Immunosuppressive treatment with immunosuppressive agent, systemic or absorbable topical hormone therapy ( prednisone or other therapeutic hormone at the dose greater than 10mg/ day) within 2 weeks before enrollment;
•Active autoimmune diseases, with the necessity of systemic treatment (hormone replacement therapy is not considered as a systemic treatment, such as type 1 diabetes) over the past two years; autoimmune diseases that did not require systemic treatment in the past two years;
•A history of immunodeficiency, including acquired/congenital immunodeficiency disorders, a history of organ transplantation;
•Vaccinated with live vaccine (inactivated virus vaccine for seasonal influenza is allowed) within 4 weeks before enrollment;

Arms & Interventions

Toripalimab and Anlotinib Combination Treatment

Patients receive toripalimab at a dose of 240 mg on day 1 and anlotinib at a dose of 12 mg before breakfast for once-daily on days 1-14. Treatment cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity

Intervention: Toripalimab and Anlotinib