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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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;

Locations
Other Locations
China
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
Contact Information
Primary
Zhao Chong PhD.
zhaochong@sysucc.org.cn
139022061610
Backup
Miao Jingjing MD.
miaojj@sysucc.org.cn
13631355201
Time Frame
Start Date: 2025-07-09
Estimated Completion Date: 2029-06
Participants
Target number of participants: 148
Treatments
Experimental: EGFR+PD-1+Chemo
Related Therapeutic Areas
Sponsors
Collaborators: Jiangxi Provincial Cancer Hospital, Second Affiliated Hospital, School of Medicine, Zhejiang University, Fujian Province Tumor Hospital, Zhejiang Cancer Hospital, Xijing hospital of The fourth military medical university, Liuzhou Workers' Hospital, Wuhan TongJi Hospital, Chongqing University Cancer Hospital, First Affiliated Hospital of Guangxi Medical University, Dongguan People's Hospital
Leads: Sun Yat-sen University

This content was sourced from clinicaltrials.gov

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