Status:
UNKNOWN
Sintilimab and Chidamide in Combination With or Without IBI305 in Advanced or Metastatic pMMR/MSS Colorectal Carcinoma
Lead Sponsor:
Sun Yat-sen University
Conditions:
Advanced Microsatellite Stable Colorectal Cancer
Metastatic Microsatellite-stable Colorectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of sintilimab and chidamide in combination with or without IBI305(bevacizumab) in patients with standard treatment failure of advanced ...
Detailed Description
In this study, we explored the potential effectiveness of combining PD-1 monoclonal antibody sintilimab with the histone deacetylase inhibitor (HDACi) chidamide, with or without IBI305(bevacizumab), i...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
March 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04724239
Start Date
March 11 2021
End Date
December 1 2023
Last Update
August 1 2023
Active Locations (1)
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1
Cancer center of Sun Yat-sen University
Guangzhou, Guangdong, China, 510060