Nimotuzumab Combined With Toripalimab/Gemcitabine/Cisplatin as First-line Therapy in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma: a Prospective, Single-arm, Phase II Clinical Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- ORR[RECIST1.1]
研究概览
简要总结
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.
详细描述
The study is to investigate the efficacy and safety of combining nimotuzumab and toripalimab with the GP regimen for first line recurrent/distant metastasis nasopharyngeal carcinoma.
This clinical trial adopts a single-center, prospective, single-arm phase II trial design. Each treatment cycle will be three weeks long, the chemotherapy regimen contains no more than 6 circles, nimotuzumab and toripalimab were used until progression.
After screening, eligible patients will be enrolled in the study. Patients will receive up to 6 cycles of nimotuzumab and toripalimab, gemcitabine, cisplatin therapy. Patients will undergo regular follow-up visits, and researchers will collect data on efficacy and safety. Short-term outcomes will be assessed according to the RECIST 1.1 criteria/irRECIST, and adverse events will be evaluated using the CTCAE 5.0.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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).
排除标准
- •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.
- •Subjects who have participated in another interventional clinical trial, undergone major surgical procedures, or scheduled for surgery within 30 days prior to screening.
- •Patients with severe underlying diseases that preclude tolerance to the treatment.
- •History of other malignancies, except for cured cervical carcinoma in situ, skin basal cell carcinoma, or malignancies cured for more than 5 years without recurrence.
- •Presence of uncontrolled comorbidities such as heart failure, diabetes mellitus, hypertension, thyroid disorders, psychiatric illnesses, etc.
- •Subjects with contraindications to immunotherapy, including those with immune dysfunction diseases (such as rheumatoid arthritis, psoriasis, systemic lupus erythematosus, HIV infection, hepatitis B, hepatitis C, chronic use of steroids for autoimmune diseases), recipients of allogeneic transplants, patients with interstitial lung disease, or those with meningeal metastasis or progressive brain metastasis.
- •Allergy to any of the drugs or their components used in the study protocol. Grade 2 or higher peripheral neuropathy or hearing loss according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.
- •Pregnant women (confirmed by blood or urine human chorionic gonadotropin [HCG] test) or lactating mothers, or subjects of reproductive age who are unwilling or unable to adopt effective contraceptive measures until at least 6 months after the last treatment in the study.
研究组 & 干预措施
Nimotuzumab combine with TGP
Base on TGP(Toripalimab, Gemcitabine, and Cisplatin) regimen, the patients will receive Nimotuzamab treatment.
干预措施: Nimotuzumab (Drug)
结局指标
主要结局
ORR[RECIST1.1]
时间窗: 3 months
objective response rate assessed by RECIST 1.1
次要结局
- OS(2 years)
- 2-year PFS rate(2 years)
- DOR(2 years)
- adverse event(3 years)
- mPFS(1 year)
- DCR(3 months)