Nimotuzumab Combined With TGP as First-line Therapy in Patients With Recurrent/Metastatic Nasopha… (NCT06509009) | Clinical Trial Compass
RecruitingPhase 2
Nimotuzumab Combined With TGP as First-line Therapy in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma
China30 participantsStarted 2024-08-30
Plain-language summary
The goal of this study is to learn the efficacy and safety of nimotuzumab combined with toripalimab and gemcitabine/cisplatin regimen treatment recurrent/distant-metastasis nasopharyngeal carcinoma.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Signed written informed consent form.
Age between 18 and 75 years, inclusive, without gender restriction.
Histologically confirmed diagnosis of recurrent/distant metastasis nasopharyngeal carcinoma, first line patients and unsuitable for local operation treatment.
EGFR expression positive.
Presence of at least one measurable lesion as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, and patients who have not undergone definitive treatment.
ECOG Performance Status (PS) score of 0 or 2.
Expected survival duration of at least 3 months.
White blood cell count ≥ 3 × 10\^9/L; absolute neutrophil count ≥ 1.5 × 10\^9/L; platelet count ≥ 100 × 10\^9/L; hemoglobin level ≥ 90 g/L.
Serum creatinine level ≤ 1.2 mmol/L or creatinine clearance ≥ 60 ml/min.
Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN) (in case of liver metastasis, ≤ 3.0 × ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN (in case of liver metastasis, ≤ 5.0 × ULN).
Female patients must have a negative urine pregnancy test prior to study enrollment (this criterion does not apply to patients with bilateral ovarian resection and/or hysterectomy or postmenopausal patients).
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Exclusion Criteria:
Subjects who have received radiotherapy, chemotherapy, immunosuppressive agents, monoclonal antibodies, oral epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs), or anti-angiogenic drugs within the past six months.…
What they're measuring
1
ORR[RECIST1.1]
Timeframe: 3 months
Trial details
NCT IDNCT06509009
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences