Real-World Study: Panitumumab N01 vs Cetuximab Plus FOLFOX in First-Line RAS Wild-Type mCRC

Korábbi kezelés

• Patients with brain metastasis accompanied by cognitive impairment, those with concomitant neuropsychiatric disorders, a history of substance abuse, alcoholism or illicit drug use, or any other conditions that would interfere with study follow-up and outcome assessment.

Más betegség

• Patients with known hypersensitivity, contraindication or precautionary use to the study treatment agents, their analogues, or other biological products.

Laborértékek

• Patients who have participated in another interventional clinical study within 4 weeks prior to the first dose or during the study exposure period (the exposure period is defined as from the date of administration of the index study drug to 28 days after the last dose; the half-life of the index drug is approximately 7 days), and received investigational anti-tumour agents such as other anti-EGFR monoclonal antibodies or other biological targeted agents; such co-administration would prevent clear attribution of efficacy or costs within the exposure period.

Egyéb

• Pregnant or lactating females.
• Patients with critical missing key variables, including RAS status, treatment regimen and index date, precluding the primary analysis.
• Patients deemed ineligible for enrolment for other reasons by the investigator.

• Aged ≥ 18 years, regardless of gender.
• Histopathologically and radiologically-confirmed metastatic colorectal cancer with RAS wild-type status (wild-type for KRAS and NRAS exons 2, 3 and 4; if test records are limited, the exact test scope and testing method should be documented); and the participant is planned to receive FOLFOX combined with either Panitumumab N01 or cetuximab/cetuximab N01.
• At least one measurable lesion assessable per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
• No prior anti-tumor therapy for colorectal cancer, including chemotherapy, radiotherapy, targeted agents, surgery and immunotherapy. Participants with disease recurrence and metastasis > 3 months after completion of adjuvant chemotherapy or prior local treatment of the primary lesion are eligible.
• Availability of at least one record of follow-up, clinic revisit, prescription, billing settlement, or imaging assessment after administration of study drug.
• Possession of a de-identified unique identifier enabling linkage between clinical data and medical insurance settlement data.
• Fully understands this study, voluntarily participates and provides written informed consent. Data collection can only be performed after written informed consent is obtained. Waiver of informed consent is permitted if approved by the local Institutional Review Board / Independent Ethics Committee (IRB/IEC).