Status:
UNKNOWN
Envafolimab as Neoadjuvant Immuntherapy in Resectable Local Advanced dMMR/MSI-H Colorectal Cancer
Lead Sponsor:
Third Affiliated Hospital, Sun Yat-Sen University
Conditions:
Colorectal Cancer
Mismatch Repair-deficient (dMMR)
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Colorectal cancer (CRC) is one of the most common malignant tumours of human beings. Mismatch Repair-deficient (dMMR)/ Microsatellite Instability-high (MSI-H) CRC is a specific subtype of CRC, which a...
Eligibility Criteria
Inclusion
- Willing and able to provide written informed consent.
- Histological or cytological documentation of adenocarcinoma of the colon or rectum.
- Tumor tissues were identified as mismatch repair-deficient (dMMR) by immunohistochemistry (IHC) method or microsatellite instability-high (MSI-H) by polymerase chain reaction (PCR).
- Male or female subjects \> 18 years \< 70 of age.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Determined CT or MRI scans (done within 14 days of registration) of the chest, abdomen and pelvis: locally advanced (cT3-4 or cN1-2 \[with the definition of a clinically positive lymph node being any node ≥ 1.0 cm\]).
- Non complicated primary tumor (obstruction, perforation, bleeding).
- No previous any systemic anticancer therapy for colorectal cancer disease or radiologic evaluation of tumor regression \< 20% or unacceptable toxic effects during neoadjuvant chemotherapy.
- Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment.
Exclusion
- Previous or concurrent cancer that is distinct in primary site or histology from colon cancer within 5 years prior to randomization.
- Significant cardiovascular disease including unstable angina or myocardial infarction within 6 months before initiating study treatment.
- Heart failure grade III/IV (NYHA-classification).
- Unresolved toxicity higher than CTCAE v.4.0 Grade 1 attributed to any prior therapy/procedure.
- Subjects with known allergy to the study drugs or to any of its excipients.
- Current or recent (within 4 weeks prior to starting study treatment) treatment of another investigational drug or participation in another investigational study.
- Breast- feeding or pregnant women
- Lack of effective contraception.
- Previously received anti-programmed death-1 (PD-1) or its ligand (PD-L1) antibody, anti-cytotoxic T lymphocyte-associated antigen 4 (cytotoxic T-lymphocyte-associated Protein 4, CTLA-4) antibody or other drug/antibody that acts on T cell costimulation or checkpoint pathways.
- With any distant metastasis.
Key Trial Info
Start Date :
May 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT05371197
Start Date
May 5 2022
End Date
December 31 2024
Last Update
May 12 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
the Third Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China, 510630