Program Status
Not yet recruitingPhase
Phase 2Prior Immunotherapy Allowed
NoCRC-directed Trial
YesDrugs
AmetumumabTags
MSI-H/ MMRd, MSS/ MMRpComments
Trial only in China. For patients who are about to receive first line for metastatic CRC.
The study compares:
ametumumab (an anti-EGFR monoclonal antibody) in combination with anti-PD-1 monoclonal antibody (immunotherapy) and FOLFIRI (chemotherapy
versus
ametumumab or cetuximab (anti-EGFR monoclonal antibody) in combination with FOLFIRI (standard of care).
Only for patients RAS wild (no KRAS or NRAS mutations) and BRAF wild (no mutated).
Location | Location Status |
---|---|
China | |
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine Hangzhou, Zhejiang 310000 |
Not yet recruiting |
Contacts
Inclusion Criteria
Inclusion Criteria:
Voluntarily sign written informed consent; Age 18 ~ 85 years (inclusive), male or female;
•Patients requiring first-line treatment for locally advanced colorectal cancer with distant metastasis or unresectable disease; Histologically or cytologically confirmed adenocarcinoma of the colon or rectum; RAS (KRAS, NRAS) gene is wild-type and no BRAF V600E mutation has been identified; Presence of at least one measurable lesion (non-radiation field) confirmed by CT or MRI that meets RECIST 1.1 criteria; Performance status (ECOG) score 0 or 1.
Exclusion Criteria
Exclusion Criteria:
Previous chemotherapy for colorectal cancerPrevious treatment with anti-EGFR monoclonal antibodies Received systemic anti-tumor treatment approved or of other clinical studies within 4 weeks prior to the first dose.
Radiotherapy or surgery within 4 weeks prior to enrollment, except for diagnostic biopsy Participation in other clinical trials within 4 weeks prior to enrollment; Severe skin disease requiring systemic treatment. Presence of serious clinical infection. Uncontrolled pleural effusion, pericardial effusion or peritoneal effusion after treatment.