Nasopharyngeal Cancinoma (NPC)Phase 1/2NCT06802835
EGFR Antibody Combined With PD-1 Inhibitor and Chemotherapy in R/M Nasopharyngeal Carcinoma
A Phase 1/2 study testing EGFR Antibody, PD-1 antibody and Gemcitabine, Cisplatin in people with Nasopharyngeal Cancinoma (NPC) and Recurrent Nasopharynx Carcinoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
This is a prospective, single-arm, phase II clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of EGFR antibody combined with programmed death 1 (PD-1) antibody and chemotherapy in recurrent/metastatic nasopharyngeal carcinoma patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nasopharyngeal Cancinoma (NPC), Recurrent Nasopharynx Carcinoma, Metastatic Nasopharyngeal Carcinoma
- What is being tested?
- EGFR Antibody, PD-1 antibody and Gemcitabine, Cisplatin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteChina
- Study dates
- 9 Jul 2025to Jun 2029
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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;
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong
Zhao Chong MD. PhD., 02087342638, zhaochong@sysucc.org.cn
Miao Jingjing MD., 86+13631355201, miaojj@sysucc.org.cn
About this study
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
This is a prospective, single-arm, phase II clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of EGFR antibody combined with programmed death 1 (PD-1) antibody and chemotherapy in recurrent/metastatic nasopharyngeal carcinoma patients.
- Conditions
- Nasopharyngeal Cancinoma (NPC), Recurrent Nasopharynx Carcinoma, Metastatic Nasopharyngeal Carcinoma
- Being tested
- EGFR Antibody, PD-1 antibody, Gemcitabine, Cisplatin, IMRT
- Keywords
- EGFR antibody, PD-1 antibody, chemotherapy
- Medical subject headings
- Nasopharyngeal Neoplasms, Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EGFR AntibodyDrug
6 cycles for combined therapy. Maintenance for 1 year.
PD-1 antibodyDrug
6 cycles for combined therapy. Maintenance for 1 year.
Gemcitabine, CisplatinDrug
6 cycles for combined therapy.
IMRTRadiation
IMRT for primary lesion
| Study group | Role | What they receive |
|---|---|---|
| EGFR+PD-1+Chemo | Experimental | Not described Receives: Drug: EGFR Antibody; Drug: PD-1 antibody; Drug: Gemcitabine, Cisplatin; Radiation: IMRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
From the date of recruiting to the first occurrence of disease progression as determined according to RECIST v1.1 or death from any cause, whichever occurs first.
Measured: 1 year
Secondary outcomes (5)
Adverse events
All adverse event or serious adverse event that occurred during the study period according to CTCAE v 5.0.
Measured: Up to 16 months
Overall survival (OS)
From the date of recruiting to the date of death from any cause.
Measured: 1 year
Objective response rate (ORR)
The percentage of patients with CR and PR assessed according to RECIST v1.1.
Measured: 1 year
Disease control rate (DCR)
The proportion of patients who have achieved complete response, partial response and stable disease according to RECIST v1.1.
Measured: 1 year
Quality of life (QoL)
Assessed by EQ-5D-5L questionnaire
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start9 Jul 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal Cancinoma (NPC)Studies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang Cancer Hospital, Wuhan TongJi Hospital, Xijing hospital of The fourth military medical university, Dongguan People's Hospital, Liuzhou Workers' Hospital, Chongqing University Cancer Hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine, Jiangxi Provincial Cancer Hospital, Fujian Province Tumor Hospital, First Affiliated Hospital of Guangxi Medical University
- Responsible party
- Principal investigator, Zhao Chong, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06802835
- Sponsor's protocol ID
- EGFR+PD-1+Chemo for r/mNPC
- Status last verified
- May 2026
- First submitted
- 25 Jan 2025
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No