Active — Not RecruitingPhase 2

Irinotecan Liposomes in Combination With Nituzumab for the Treatment of Recurrent/Metastatic Nasopharyngeal Carcinoma After Failure of First-Line or Higher Immunotherapy

China38 participantsStarted 2024-05-22

Plain-language summary

Nasopharyngeal cancer is a malignant tumor that arises from the cells of the nasopharyngeal epithelium, with its occurrence spread across different regions worldwide. Recent data from China in 2015 revealed approximately 6.0 million new cases of nasopharyngeal cancer, leading to approximately 34,000 deaths. When choosing a chemotherapy regimen for patients with metastatic nasopharyngeal cancer, the gemcitabine and cisplatin combination (GP) is typically recommended as the initial treatment. However, it is common for patients to experience disease progression after receiving first-line chemotherapy, highlighting the importance of a well-defined second-line treatment plan. Recent clinical studies have indicated that combining nituzumab with radiotherapy can enhance treatment efficacy with minimal side effects, providing promising results for advanced nasopharyngeal cancer patients. Additionally, the use of irinotecan liposome injection has proved beneficial in modifying the drug's pharmacokinetics, resulting in improved drug delivery to the tumor site while reducing toxicity in healthy tissues. This study aims to explore the effectiveness and safety of combining irinotecan liposome with nituzumab treatment for recurrent metastatic nasopharyngeal carcinoma that has not responded to initial immunotherapy. Participants selected for this clinical trial will receive a treatment regimen consisting of liposomal irinotecan administered intravenously at a dose of 70 mg/m2 on day 1, along with nituzumab given at a dose of 400 mg via intravenous injection on the same day. This treatment cycle will be repeated every two weeks for a maximum of eight cycles, or until disease progression, intolerable side effects, or other criteria necessitating discontinuation of treatment as determined by the investigator. By evaluating the efficacy and safety of this combined regimen, investigators aim to establish a novel therapeutic approach for managing advanced nasopharyngeal carcinoma in the context of current immunotherapy advancements.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * 1\. subjects volunteered to participate in the study and signed an informed consent form (ICF); 2. age ≥ 18 years; and 3. previous histopathological diagnosis of non-keratinizing carcinoma of the nasopharynx (differentiated or undifferentiated, i.e., WHO classification type II or III); and 4. positive EGFR test; 5. patients with recurrent/metastatic nasopharyngeal cancer who have received prior treatment with first-line or higher standard regimens containing PD-1/PD-L1 inhibitors; 6. at least 1 evaluable lesion at baseline according to RECIST 1.1 criteria; the area must not have received prior radiotherapy or there must be evidence of significant progression of the lesion after completion of radiotherapy; 7. ECOG score 0 to 1; expected survival ≥ 3 months 8. No serious cardiac, pulmonary, hepatic, renal or other vital organ dysfunction; normal hepatic and renal function: AST, ALT \<2.5 times the upper limit of normal, total bilirubin \<1.5 times the upper limit of normal; serum creatinine ≤1.5 × the upper limit of normal and creatinine clearance ≥ 30 mL/min; adequate bone marrow function: peripheral blood leukocytes \>4.0 × 109/L, neutrophils \>1.0 × 109/L, hemoglobin \>90%. 109/L, hemoglobin \> 90 g/L, platelets \> 100 × 109/L; Exclusion Criteria: * 1\. history of hypersensitivity to monoclonal antibodies; hypersensitivity to liposomal irinotecan; 2. use of a strong inducer of CYP3A4 within 2 weeks or a strong inhibitor of CYP3A4 or a strong inhibito…

What they're measuring

Objective remission rate (ORR)

Timeframe: up to 2 years

Trial details

NCT IDNCT06414577

SponsorXIANG YANQUN

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-23