计划状态
活跃，非招募阶段
第二阶段允许先接受免疫治疗
没有CRC 指导的试验
是药物
chidamide, IBI305, Sintilimab标签
MSS/ MMRp评论
Trial in China, for MSS CRC patients, without prior anti PD-1. Two arms:
1. sintilimab (anti P-1) + chidamide (HDAC inhibitor) + IBI305 (bevacizumab biosimilar; similar to Avastin;
2. sintilimab + chidamide
有用链接
A phase II clinical trial of sintilimab plus chidamide combined with or without bevacizumab in patients with MSS/pMMR metastatic colorectal cancer Combined anti-PD-1, HDAC inhibitor and anti-VEGF for MSS/pMMR colorectal cancer: a randomized phase 2 trial| 地点 | 位置状态 |
|---|---|
| 中国 | |
|
Cancer center of Sun Yat-sen University Guangzhou, Guangdong 510060 |
活跃，非招募 |
纳入标准
纳入标准
Histologically confirmed diagnosis of unresectable locally advanced, recurrent or metastatic colorectal adenocarcinoma.
Tumor tissues were identified as mismatch repair-proficient (pMMR) by immunohistochemistry (IHC) method or microsatellite stability (MSS) by polymerase chain reaction (PCR).
Subjects must have failed at least two lines of prior treatment.
Subjects must have one measurable lesion according to RECIST v1.1 at least.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
18-75 years old.
Life expectancy of at least 12 weeks.
Adequate bone marrow, liver, renal and coagulation function as assessed by the laboratory required by protocol
排除标准
排除标准：
Previously received anti-programmed death-1 (PD-1) or its ligand (PD-L1) antibody or histone deacetylase (HDAC) inhibitor.
Received last dose of anti-tumor therapy (chemotherapy, targeted therapy, tumor immunotherapy or arterial embolization) within 3 weeks of the first dose of study medication.
Received radiotherapy with 4 weeks of the first dose of study medication.
Underwent major operation within 4 weeks of the first dose of study medication or open wound, ulcer or fracture.
Known symptomatic central nervous system (CNS) metastasis and/or carcinomatous meningitis. Subjects received prior treatment and have stable disease more than 4 weeks from first dose of study medication are permitted to enroll.
Active, known or suspected autoimmune disease or has a history of the disease within the last 2 years.
Interstitial lung disease requiring corticosteroids.
Active or poorly controlled serious infections.
Significant malnutrition.
Symptomatic congestive heart failure (NYHA Class II-IV) or symptomatic or poorly controlled arrhythmia.
Uncontrolled hypertension (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg) despite standard treatment.
Within 6 months prior to the enrollment, history of gastrointestinal perforation and/or fistula, gastrointestinal ulcer, bowel obstruction, extensive bowel resection, Crohn's disease, or ulcerative colitis, intra-abdominal abscesses, or long-term chronic diarrhea.
History or evidence of inherited bleeding diathesis or coagulopathy or thrombus
Any life-threatening bleeding within 3 months prior to the enrollment.
High risk of bleeding.
