A phase II study of chemotherapy in combination with telomerase peptide vaccine (?????) as second-line treatment in patients with metastatic colorectal cancer
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 55
研究概览
简要总结
From May 13, 2015 to October 13, 2020, a total of 56 patients with recurrent or metastatic colorectal cancer were enrolled in this study. The patients had a median age of 64 (range, 29-82) and 67.9% of the patients were male. 66.1% of the patients had left-side colorectal cancer and RAS mutation was identified in 25%. Of all patients, 12 patients who did not undergo at least one cycle of treatment or tumor assessment were excluded from the efficacy analysis. In modified intention-to-treat population, disease control rate and objective response rate were 90.9% (95% Confidence interval [CI], 82.4-99.4) and 34.1% (95% CI, 20.1-48.1), respectively. The median progression free survival was 7.1 months (95% CI, 5.2- 9.1) and the median overall survival was 12.8 months (95% CI, 9.9-15.8). Most common all-grade adverse events were neutropenia (48.2%), nausea (26.8%), neuropathy (25.0%), stomatitis (21.4%), diarrhea (21.4%) and grade 3 or higher adverse events were neutropenia (16.1%), nausea (7.1%) and vomiting (7.1%).
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1. Histologically or cytologically confirmed metastatic colorectal cancer patients eligible for 2nd line palliative chemotherapy
- •2. Patients who have measurable disease as defined by Response Evaluation Criteria In Solid Tumors Guideline version 1.1 (RECIST 1.1) (No prior radiation therapy to measurable lesion)
- •3. Patients who failed 1st line chemotherapy or recurred during adjuvant chemotherapy or recurred within 6 months of completion of adjuvant chemotherapy
- •4. Age = 19 years
- •5. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •6. Life expectancy = 12 weeks
- •7. Adequate hematopoietic function (hemoglobin = 9.0 g/dL; absolute neutrophil count = 1,500/µL; platelet count = 100,000/µL)
- •8. Adequate hepatic function (total bilirubin < 2.5xULN, transaminase < 2.5xULN, < 5xULN, if liver metastases are present)
- •9. Adequate renal function (serum creatinine = 1.5 mg/dL, or creatinine clearance = 50 mL/min)
- •10. Patients should sign a written informed consent before study entry
排除标准
- •. Exclusion criteria
- •1. Other malignancy within the past 5 years except cured non-melanomatous skin cancer or carcinoma in situof the cervix.
- •2. History of clinically significant heart disease within the past 12 months (eg, refractory congestive heart failure, symptomatic coronary artery diseases, arrhythmia, myocardial infarction).
- •3. Serious concurrent infection requiring antibiotics.
- •4. Pregnant or breastfeeding women.
- •5. Patients with evidence of CNS metastasis. Patients with uncontrolled seizure or CNS disorder or psychiatric disorder.
- •6. History of allogenic transplantation (eg, kidney, liver transplantation)
- •7. Patient or caregiver who does not understand or consent to the written consent.
- •8. Patients receiving a concomitant treatment with drugs interacting with study drug.
- •9. Patients who have allergy to study drug.
- •10. Patients with malabsorption syndrome based on domestic authorization of the study drug.
- •11. Patients who need to take medication that affects the immune response (eg, long-term steroid administration or other immunosuppressants). However, short-term steroid usage for symptom relief associated with cancer is permissible.
- •12. Patients who participated in other clinical trials within 4 weeks before enrollment and taking other clinical trial drugs.
- •13. Patients who received radiation therapy within 8 weeks prior to enrollment.
- •14. Patients who have been identified not to be suitable for the study.