Combination of Metronomic Capecitabine With Camrelizumab for Treatment of Refractory Solid Tumor (McCrest) Trial: Hepatobiliary, Pancreatic and Other Gastrointestinal Carcinoma (Non-stomach, Non-esophagi) (Cohort 3)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Rate of adverse events as assessed by CTCAE v5.0
研究概览
简要总结
This is a single center phase 1 trial to observe safety and efficacy of metronomic capecitabine plus PD-L1 antibody camrelizumab to treat hepatobiliary, pancreatic and other gastrointestinal carcinoma (non-stomach, non-esophagi) patients who had disease progression after all standard regimens.
This study is one of the cohorts of a multi-cohort trial called Combination of Metronomic capecitabine with Camrelizumab for treatment of refractory solid tumor (McCrest) trial.
详细描述
Hepatobiliary, pancreatic and other gastrointestinal carcinoma (non-stomach, non-esophagi) patients who had disease progression after all standard regimens will be treated by metronomic capecitabine plus camrelizumab. Metronomic capecitabine will be given as fixed dose (500mg bid) orally. Camrelizumab will be given two-weekly (200mg once) intravenously. This regimen will be administered until progression of disease, intolerable toxicity or withdraw of consent.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male/female patients aged≥18 years.
- •Histologically confirmed hepatobiliary, pancreatic and other gastrointestinal carcinoma (non-stomach, non-esophagi), without uncontrolled pleural effusion or ascites.
- •Patients with advanced or metastatic disease who have disease progression after all standard regimens, with measurable or unmeasurable lesions.
- •MSS or pMMR.
- •ECOG performance status 0 or 2, expected lifetime≥3 months.
- •Adequate organ function: Absolute neutrophil count (ANC) ≥1.5x109/L, White blood count ≥3.5x109/L, Platelets ≥75x109/L, Hemoglobin (Hb) ≥70g/L, ALT/AST ≤2.5x ULN (for patient with liver metastasis ALT/AST ≤5x ULN), Serum bilirubin ≤1.5x ULN, Serum creatinine ≤1.5x ULN.
- •HBV infected patients (inactive/asymptomatic carrier, chronic or active) with HBV DNA<500IU/ml (or 2500 copies/ml).
- •Pregnancy test of female patients with fertile activity should be negative within 7 days before enrollment. Patients should keep contraception during treatment.
- •Willingness and ability to comply with the protocol for the duration of the study including scheduled visits, examinations, investigations and treatment plans with informed consent form.
排除标准
- •Pregnancy or children bearing potential.
- •Brain or meningeal metastasis.
- •With second primary malignant diseases.
- •With uncontrolled auto-immune diseases, interstitial pneumonia, ulcerative colitis, or patients who should receive long-term glucocorticoid treatment (>10mg/d prednisone).
- •With uncontrollable complications
- •Inadequate organ function
- •Conditions which impact on pill taking (dysphagia, chronic diarrhea, bowel obstruction).
- •known hypersensitivity reaction to any of the study drugs or components.
- •Other unsuitable conditions determined by investigators.
研究组 & 干预措施
Experimental
Capecitabine 500mg bid. po. Camrelizumab 200mg ivgtt. d1 q2w
干预措施: Capecitabine, Camrelizumab (Drug)
结局指标
主要结局
Rate of adverse events as assessed by CTCAE v5.0
时间窗: 48 months
次要结局
- Disease control rate(48 months)
- Duration of response(48 months)
- Overall survival(48 months)
- Objective response rate(48 months)
- Progression free survival(48 months)
研究者
Jun Zhang
Chair of Department of Oncology
Ruijin Hospital