Brief Title
Apatinib and Camrelizumab in Recurrent or Metastatic Nasopharyngeal Carcinoma With First-line Treatment Failure
Official Title
Apatinib Combined With Camrelizumab in Recurrent or Metastatic Nasopharyngeal Carcinoma Who Failed at Least the First-line Treatment
Brief Summary
This is a prospective phase II clinical trial to evaluate the efficacy and safety of apatinib
and camrelizumab in recurrent or metastatic nasopharyngeal carcinoma who failed at least the
first-line treatment.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Objective response rate
Secondary Outcome
The proportion of patients who achieved disease control
Condition
Nasopharyngeal Carcinoma
Intervention
Apatinib plus Camrelizumab
Study Arms / Comparison Groups
Apatinib plus Camrelizumab arm
Description: Subjects receive apatinib plus camrelizumab
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
57
Start Date
May 5, 2020
Completion Date
May 5, 2022
Primary Completion Date
January 1, 2022
Eligibility Criteria
Inclusion Criteria:
1. Male or female; 18-70 years of age.
2. Subjects diagnosed with pathological confirmed metastatic nasopharyngeal carcinoma, or
subjects with recurrent NPC that is unfit for local treatment
3. Underwent at least first-line treatment failure
4. ECOG performance status of 0 or 1.
5. Life expectancy more than 12 weeks.
6. Subjects enrolled must have measurable lesion(s) according to response evaluation
criteria in solid (RECIST) v1.1.
7. Adequate organ function assessed by laboratory parameters during the screening period.
8. Female subjects agree not to be pregnant or lactating from beginning of the study
screening through at least 3 months after receiving the last dose of study treatment.
Both men and women of reproductive potential must be willing and able to employ a
highly effective method of birth control/contraception to prevent pregnancy.
9. Able to understand and sign an informed consent form (ICF).
Exclusion Criteria:
1. Subjects with any active autoimmune disease or history of autoimmune disease, or
history of syndrome that requires systemic steroids or immunosuppressive medications,
including but not limited to the following: rheumatoid arthritis, pneumonitis, colitis
(inflammatory bowel disease), hepatitis, hypophysitis, nephritis, hyperthyroidism, and
hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy.
Subjects with the following conditions will not be excluded from this study: asthma
that requires intermittent use of bronchodilators, hypothyroidism stable on hormone
replacement, vitiligo, Graves' disease, or Hashimoto's disease. Additional exceptions
may be made with medical monitor approval;
2. Known history of hypersensitivity to any components of the Camrelizumab formulation or
other monoclonal antibodies ;
3. Concurrent medical condition requiring the use of immunosuppressive medications, or
immunosuppressive doses of systemic or absorbable topical corticosteroids. Doses 10
mg/day prednisone or equivalent are prohibited within 4 weeks before study drug
administration. Note: corticosteroids used for the purpose of IV contrast allergy
prophylaxis are allowed;
4. Subjects who underwent anti-PD-1 /PD-L antibody or anti-CTLA-4 antibody (or any other
antibody acting on T cell synergistic stimulation or checkpoint pathway) and
anti-angiogenic drugs.
5. Abnormal coagulation function (INR>1.5×ULN, APTT>1.5×ULN) with bleeding tendency.
6. The laboratory test values within 7 days before enrollment do not meet the relevant
standards.
7. Active central nervous system (CNS) metastases (indicated by clinical symptoms,
cerebral edema, steroid requirement, or progressive disease);
8. Diagnosed with other malignant tumors.
9. Uncontrolled clinically significant medical condition, including but not limited to
the following:
1. Hypertension that cannot be reduced to the normal range after antihypertensive
drug
2. congestive heart failure (New York Health Authority Class > 2),
3. unstable angina,
4. myocardial infarction within the past 12 months,
5. clinically significant supraventricular arrhythmia or ventricular arrhythmia
requiring treatment or intervention;
10. Active bleeding, ulcer, intestinal perforation, major surgery in the previous month;
Patients with tumors close to the internal carotid artery or other large vessels, thus
at risk of massive bleeding
11. Active infection or an unexplained fever; 38.5°C during screening visits or on the
first scheduled day of dosing (at the discretion of the investigator, subjects with
tumor fever may be enrolled);
12. History of immunodeficiency including seropositivity for human immunodeficiency virus
(HIV), or other acquired or congenital immune-deficient disease; active tuberculosis
(TB), anti-TB treatment is ongoing or within 1 year prior to screening; Evidence of
hepatitis B virus (HBV) or hepatitis C virus (HCV) infection or risk of reactivation
based on institutional guidelines and tests. Testing may include the following: HBV
DNA, HCV RNA, hepatitis B surface antigen, or anti-Hepatitis B core antibody.
13. Received any anti-infective vaccine (e.g. influenza vaccine, varicella vaccine, etc.)
within 4 weeks prior to enrollment.
14. Any other medical (eg, pulmonary, metabolic, congenital, endocrinal, or CNS disease),
psychiatric, or social condition deemed by the investigator to be likely to interfere
with a subject's rights, safety, welfare, or ability to sign informed consent,
cooperate, and participate in the study or would interfere with the interpretation of
the results;
Gender
All
Ages
18 Years - 70 Years
Accepts Healthy Volunteers
No
Contacts
, 86-20-8734-3361, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT04586088
Organization ID
SYSUCC-CMY-2020-2103
Responsible Party
Principal Investigator
Study Sponsor
Sun Yat-sen University
Study Sponsor
, ,
Verification Date
October 2020