Overview

Gemcitabine and Cisplatin With/Without Anlotinib in Advanced Nasopharyngeal Carcinoma

Status:
Unknown status
Trial end date:
2021-07-30
Target enrollment:
0
Participant gender:
All
Summary
This is a Phase III randomized controlled multi-center trial comparing anlotinib plus Gemcitabine/Cisplatin with placebo plus Gemcitabine/Cisplatin in previous untreated patients with recurrent/metastatic Nasopharyngeal Carcinoma, in order to verify the efficacy and security of anlotinib in mNPC patients.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd
Treatments:
Cisplatin
Gemcitabine
Criteria
Inclusion Criteria:

1. Informed of the investigational nature of this study and give written informed consent

2. Histologically or cytologically confirmed nasopharyngeal carcinoma, tumor staged as
IVB (according to the 8th AJCC edition) or recurrent tumor nott suitable for local
treatment.

3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 to1, life
expectancy of at least 12 weeks.

4. Antitumor therapy naive for recurrent or metastatic nasopharyngeal carcinoma

5. Completed radiotherapy for local tumor 4 weeks before the enrollment

6. Measurable disease other than brain metastasis based on Response Evaluation Criteria
in Solid Tumors (RECIST) version 1.1

7. Adequate organ system function, defined as follows:

1. ANC ≥1.5×109/L, PLT ≥100×109/L, Hb)≥90g /L;

2. TBIL ≤ 1.5×ULN;Aminopherases (ALT and AST) ≤ 2.5 × ULN (without liver metastasis)
or ≤ 5.0 × ULN (with liver metastasis), Creatinine ≤ 1.5 × ULN or creatinine
clearance ≥ 50 ml/min;

3. Urine protein < ++,or urine protein ≥ ++ concomitant with content of -hour
urinary protein <1.0 g;

4. INR≤1.5×ULN, APTT≤1.5×ULN;

5. LVEF ≥50%;

8. Women who are not of child-bearing potential, and women of child-bearing potential who
have a negative serum or urine pregnancy test prior to initial trial treatment, and
who agree to use adequate contraceptive measures during the study; Men with partners
of childbearing potential willing to use adequate contraceptive measures during the
study

Exclusion Criteria:

1. Patients with a previous malignancy within the past 5 years (other than curatively
treated in situ carcinoma of the cervix, non-melanoma skin cancer and superficial
bladder carcinoma).

2. Allergic to anotinib or the chemotherapeutic agents involved in this trial;

3. Supposed to receive locally treatment (except for those with symptomatic bone
metastases receive appropriate local doses radiotherapy which does not affect the
hemogram)

4. Patients that have received definitive radiotherapy, adjuvant chemotherapy or
cocurrent chemoradiotherapy for stage I-IVA and developed recurrent disease within 6
months;

5. Patients that have previously received target therapies;

6. Patients that have previously received immunotherapy (i.e.,interferon, or IL-2 ) 28
days before randomization or within 5 half-life of the drug.

7. Patients that have previously received immunosupressive drugs (i.e., Corticosteroids,
cyclophosphamide, azathioprine, methotrexate, thalidomide or TNF-α)

8. Symptomatic CNS metastasis (i.e. encephaledema, hormone intervention, or brain
metastasis progression)

9. Patients currently have bleeding tendency, including but not limited to
gastrointestinal bleeding, nasal bleeding, hemoptysis, and persistent bleeding or
coagulopathy;

10. Hemoptysis (defined as coughing out or spitting out ≥ 1 teaspoon of blood or small
blood clots or hemoptysis without sputum) within 28 days before randomization, not
including bloody sputum.

11. Radiograph (within 28 days before randomization) showed that the tumor surrounded
important blood vessels, and the investigators determined that entering the study
would cause bleeding risk;

12. Subjects have any of the following severe acute complications:

1. Unstable angina and/or congestive heart failure or vascular disease (eg, aortic
aneurysm requires surgically repaired or peripheral venous thromboembolism)
requiring hospitalization within 12 months, or other cardiac impairments
(eg,uncontrolled arrhythmias) determined by the investigator, which may affect
the evaluation of drug safety; Myocardial infarction or ischemia with ST
elevation ≥ 2 mm indicated by ECG;

2. Arterial thromboembolism, venous thromboembolism in grade 3 or higher (according
to NCI-CTCAE), transient ischemic attack (TIA), cerebral vascular accident (CVA),
transmural myocardial infarction ( MI), hypertensive crisis or hypertensive
encephalopathy within 24weeks;

3. Chronic Obstructive Pulmonary Disease (COPD) or other respiratory diseases
requiring hospitalization within 28 days before randomization;

4. Abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, or
acute gastrointestinal bleeding within 24 weeks before randomization;

5. Esophageal and gastric varices, unhealed ulcers, unhealed wounds or fracture
within 24 weeks before randomization;

6. Pulmonary infections and/or acute bacterial or fungal infections requiring
intravenous antibiotic therapy

7. Clinical jaundice and/or coagulation disorders caused by liver dysfunction;

8. Minor surgical procedures (including catheterization, excluding peripheral
venipuncture central vena catheterization) within 2 days of randomization;

13. The virological test indicates that either of the following 28 days before
randomization

1. HBsAg positive and HBV DNA ≥ 1 × 103 copies/L;

2. Anti-HCV positive

3. HIV positive

14. Participation of an anti-tumor clinic trial within 28 days before randomization