Official Title
EGFR Antibody Combined With Programmed Death-1 Inhibitor and Chemotherapy in Recurrent/Metastatic Nasopharyngeal Carcinoma: A Prospective, Multi-center, Phase I/II Clinical Trial
Brief Summary

This is a prospective, single-arm, phase II clinical trial. The purpose of this study isto evaluate the efficacy and adverse effect of EGFR antibody combined with programmeddeath 1 (PD-1) antibody and chemotherapy in recurrent/metastatic nasopharyngeal carcinomapatients.

Detailed Description

Not Provided

Recruiting
Nasopharyngeal Cancinoma (NPC)
Recurrent Nasopharynx Carcinoma
Metastatic Nasopharyngeal Carcinoma

Drug: EGFR Antibody

6 cycles for combined therapy. Maintenance for 1 year.

Drug: PD-1 antibody

6 cycles for combined therapy. Maintenance for 1 year.

Drug: Gemcitabine, Cisplatin

6 cycles for combined therapy.

Radiation: IMRT

IMRT for primary lesion

Eligibility Criteria

Inclusion Criteria:

- Patients with nasopharyngeal carcinoma who have recurred/metastasized after initial
treatment or radical treatment;

- Age 18-75, male or female;

- Pathological diagnosis of nasopharyngeal carcinoma;

- ECOG score 0-1;

- Have not previously received any anti-tumor therapy such as radiotherapy,
chemotherapy, immunotherapy or biotherapy for recurrence/metastasis;

- No contraindications of chemotherapy, immunotherapy and targeted therapy;

- At least 1 measurable lesion that meets RECIST 1.1 criteria;

- Blood routine examination standards should meet: WBC≥3.0×109/L, ANC≥1.5×109/L,
PLT≥100×109/L, HGB≥90g/L (no blood transfusion and blood products within 14 days, no
G-CSF and other hematopoietic stimulating factors are used to correct);

- Biochemical tests should meet the following criteria: TBIL≤2.0×ULN, ALT,
AST≤2.5×ULN, BUN and CRE≤1.5×ULN or endogenous creatinine clearance ≥60ml/min
(Cockcroft-Gault formula);

- Good coagulation function: defined as International standardized ratio (INR) or
prothrombin time (PT) ≤1.5 times ULN; If the subject is receiving anticoagulant
therapy, as long as PT is within the intended range of anticoagulant drug use;

- The myocardial enzyme spectra were in the normal range;

- Women of childbearing age must already be using reliable contraception or have had a
pregnancy test (serum or urine) within 7 days of enrollment with a negative result
and be willing to use an effective method of contraception during the trial and for
3 months after the last anti-PD-1 antibody administration. For male subjects whose
partners are women of reproductive age, effective contraception should be used
during the trial and within 3 months after the last anti-PD-1 antibody
administration;

- The subjects voluntarily joined the study, signed informed consent, had good
compliance, and cooperated with follow-up;

Exclusion Criteria:

- Patients with recurrence who can be treated with local resection or radiotherapy;

- Known to be allergic to the investigational drug or any excipients thereof, or has
had a severe allergic reaction to other monoclonal antibodies;

- Patients have symptoms of central nervous system metastasis such as brain edema and
need hormonal intervention;

- Had an active infection or unexplained fever >38.5℃ during screening or prior to the
first dose (the investigator determined that the subject's fever due to the tumor
could be enrolled);

- Have any active autoimmune disease or history of autoimmune disease (e.g.,
interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis,
myocarditis, nephritis, hyperthyroidism, hypothyroidism [may be included after
normal hormone replacement therapy]); Patients with vitiligo or complete remission
of asthma in childhood without any intervention as adults could be included, but
patients with asthma requiring medical intervention with bronchodilators could not
be included;

- Have congenital or acquired immunodeficiency (such as HIV), active hepatitis B
(HBV-DNA≥103 copy number /ml), or hepatitis C (hepatitis C antibody positive and
HCR-RNA above the lower detection limit of analytical methods);

- Previous or co-existing uncured malignancies, except cured basal cell carcinoma of
the skin, carcinoma in situ of the cervix and superficial bladder cancer;

- Uncontrolled cardiovascular disease: Grade II or higher myocardial ischemia or
myocardial infarction, poorly controlled arrhythmias (including QTc interval ≥470
ms); Patients with grade III-IV cardiac insufficiency according to NYHA standards,
or left ventricular ejection fraction (LVEF) <50% indicated by cardiac color
ultrasound; Myocardial infarction within 1 year;

- If the subject has undergone major surgery, the toxic effects and/or complications
of the surgical intervention must be fully recovered before treatment is initiated;

- Within 4 weeks prior to the first use of the investigational drug (participants in
the follow-up period are counted as the last use of the investigational drug or
device) or are currently participating in another clinical study;

- Live vaccine received within 4 weeks prior to the first administration of the
investigational drug is allowed to receive inactivated virus vaccine for seasonal
influenza by injection, but not live attenuated influenza vaccine for nasal
administration;

- Pregnant or lactating women;

- In the investigator's judgment, the subjects had other factors that might have led
to their forced discontinuation of the study, such as other serious medical
conditions (including mental illness) requiring concomitant treatment, serious
abnormalities in laboratory test values, or family or social factors that might have
affected the safety of the subjects or the circumstances of the trial data
collection.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 75 Years
Countries
China
Locations

Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China

Investigator: Zhao Chong MD. PhD.
Contact: 02087342638
zhaochong@sysucc.org.cn

Contacts

Zhao Chong PhD.
139022061610
zhaochong@sysucc.org.cn

Miao Jingjing MD.
13631355201
miaojj@sysucc.org.cn

Not Provided

Sun Yat-sen University
NCT Number
Keywords
EGFR antibody
PD-1 antibody
Chemotherapy
MeSH Terms
Carcinoma
Nasopharyngeal Carcinoma
Gemcitabine
Antibodies
Immunoglobulins