Efficacy and Safety of MRG003 With PD-1 Induction Followed by Capecitabine and PD-1 Maintenance as First-line Treatment in Locally Recurrent Nasopharyngeal Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 25
- 主要终点
- Objective Response Rate
研究概览
简要总结
This study enrolls patients who have experienced local recurrence of nasopharyngeal carcinoma (NPC) with or without regional recurrence. The treatment regimen includes an induction phase with MRG003 at 2.0 mg/kg (D1) combined with Tislelizumab 200 mg (D1), administered weekly for 6 cycles. This is followed by maintenance therapy consisting of Capecitabine (650 mg/m², twice daily on days 1-21) in combination with Tislelizumab, continued for up to 1 year or until disease progression.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •**Inclusion Criteria:**
- •Patients with locally recurrent nasopharyngeal carcinoma (NPC) more than 1 year after initial radical treatment for non-metastatic NPC, with or without regional recurrence, but without distant metastasis.
- •Age 18-70 years.
- •Pathologically confirmed local recurrence of NPC, staged as rT1-rT4 according to the 9th edition of the AJCC/UICC classification.
- •ECOG performance status score of 0-
- •No prior radiotherapy, chemotherapy, immunotherapy, or biological therapy for recurrent NPC.
- •No contraindications to immunotherapy or chemotherapy.
- •Adequate organ function.
排除标准
- •**Exclusion Criteria:**
- •Previous treatment with other PD-1 antibodies or immunotherapy targeting PD-1/PD-L1 resulting in Grade III or higher immune-related adverse reactions.
- •Residual toxic effects from prior anti-tumor treatments (including immunotherapy, targeted therapy, chemotherapy, or radiotherapy) (excluding alopecia, fatigue, and Grade 2 hypothyroidism) or clinically significant laboratory abnormalities higher than Grade 1 (CTCAE v5.0).
- •Congenital or acquired immunodeficiency (e.g., HIV infection), active hepatitis B (HBV-DNA ≥10 copies/ml), or hepatitis C (positive hepatitis C antibody and HCV-RNA above the detection limit of the assay).
- •Known allergy to MRG003, capecitabine, or any component of anti-PD-1 antibodies.
研究组 & 干预措施
MRG003
The treatment regimen comprises an induction phase with MRG003 at 2.0 mg/kg (administered on Day 1) in combination with Tislelizumab 200 mg (also on Day 1), delivered every three weeks for a total of six cycles. Upon achieving an objective response (ORR), patients will proceed to maintenance therapy, which consists of Capecitabine (650 mg/m², administered twice daily on Days 1-21) in conjunction with Tislelizumab. This maintenance phase will continue for up to one year or until disease progression is observed.
干预措施: MRG003 (Drug)
MRG003
The treatment regimen comprises an induction phase with MRG003 at 2.0 mg/kg (administered on Day 1) in combination with Tislelizumab 200 mg (also on Day 1), delivered every three weeks for a total of six cycles. Upon achieving an objective response (ORR), patients will proceed to maintenance therapy, which consists of Capecitabine (650 mg/m², administered twice daily on Days 1-21) in conjunction with Tislelizumab. This maintenance phase will continue for up to one year or until disease progression is observed.
干预措施: Tislelizumab (Drug)
MRG003
The treatment regimen comprises an induction phase with MRG003 at 2.0 mg/kg (administered on Day 1) in combination with Tislelizumab 200 mg (also on Day 1), delivered every three weeks for a total of six cycles. Upon achieving an objective response (ORR), patients will proceed to maintenance therapy, which consists of Capecitabine (650 mg/m², administered twice daily on Days 1-21) in conjunction with Tislelizumab. This maintenance phase will continue for up to one year or until disease progression is observed.
干预措施: Capecitabine (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: Day 21 after the completion of six cycles of MRG003 treatment
The Objective Response Rate (ORR) is defined as the proportion of patients achieving Complete Response (CR) or Partial Response (PR) by Day 21 after the completion of six cycles of MRG003 treatment, starting from the date of enrollment.
次要结局
- Progression-Free Survival (PFS)(1-year; 3-year)
- Overall Survival (OS)(1-year; 3-year)
- Duration of Response (DOR)(1-year; 3-year)
- Disease Control Rate (DCR)(Day 21 after the completion of six cycles of MRG003 treatment)
研究者
Qiaojuan Guo
PhD
Fujian Cancer Hospital