A Clinical Study to Evaluate the Efficacy and Safety of Envafolimab Combined With Cetuxima-βand m… (NCT06959693) | Clinical Trial Compass
Not Yet RecruitingPhase 2/3
A Clinical Study to Evaluate the Efficacy and Safety of Envafolimab Combined With Cetuxima-βand mFOLFOX6 in Patients With MSS, RAS/BRAF Wild-Type Metastatic Colorectal Cancer (mCRC)
China590 participantsStarted 2025-06-01
Plain-language summary
This is a prospective randomized controlled Phase Ⅱ/Ⅲ Clinical study to evaluate the clinical efficacy and safety of Envafolimab combining with Cetuximab -β and mFOLFOX6 in Patients With MSS, RAS/BRAF Wild-Type Metastatic Colorectal Cancer (mCRC)
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Prior to enrollment, the participant is required to sign a written informed consent form.
✓. Participants should be above 18 years，regardless of gender.
✓. Tumors with RAS (KRAS, NRAS, HRAS) and BRAF wild-type, MSS phenotype, excluding appendiceal or anal cancer. All listed codons must be wild-type: KRAS: Exons 2, 3, 4 (Codons 12, 13, 59, 61, 117, 146) ; NRAS: Exons 2, 3, 4 (Codons 12, 13, 59, 61, 117, 146)
✓. Imaging (enhanced CT/MRI/PET-CT) confirms advanced/metastatic colorectal cancer with measurable lesions according to RECIST v1.1.
✓. No prior systemic therapy for advanced/metastatic colorectal cancer, including chemotherapy, EGFR inhibitors (cetuximab, panitumumab), VEGF inhibitors (bevacizumab), and immune checkpoint inhibitors (anti-PD-1/PD-L1/CTLA-4). Adjuvant/neoadjuvant chemotherapy within 6 months before recurrence/metastasis is considered first-line therapy.
✓. ECOG PS score 0-1.
✓. Expected survival \>12 weeks.
Exclusion criteria
✕. Other malignancies in the past or current (excluding cured basal cell carcinoma or cervical carcinoma in situ).
✕. Current duodenal ulcer, ulcerative colitis, intestinal obstruction, or other GI conditions that may cause bleeding or perforation, as judged by the investigator.
What they're measuring
1
Progressin Free Survival，PFS
Timeframe: Time Frame: from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 3 years