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

NCT07917429 · tracked via the Priya Life Science China tracker

Sponsor

Fujian Medical University Union Hospital

Phase

Observational

Started

2027-01-01

Last updated

2026-11-04

Condition(s) studied

Colorectal Cancer Metastatic

Investigational drug(s) / intervention(s)

Panitumumab N01Cetuximab (EGFR inhibitor) →

Panitumumab N01: Panitumumab N01 plus FOLFOX

Cetuximab (EGFR inhibitor): cetuximab or cetuximab N01 plus FOLFOX

Study summary

This is a prospective, observational, multicenter cohort study. Subjects will be divided into the Panitumumab N01 group (experimental group) and the cetuximab or cetuximab N01 group (control group) according to the treatment they actually receive. Both groups will receive FOLFOX chemotherapy. Real-world follow-up data will be used to comprehensively evaluate clinical efficacy, safety and health economic outcomes between the two groups.

No fewer than 610 patients planned to receive first-line treatment for colorectal cancer with FOLFOX combined with Panitumumab N01 or cetuximab/cetuximab N01 will be enrolled (305 patients in the cetuximab/cetuximab N01 arm and 305 patients in the Panitumumab N01 arm). After enrollment, medical records of participants will be collected, including baseline characteristics, laboratory test results, radiological assessments, medication history and survival status, with follow-up continuing until March 2030. Adverse events will be collected up to 28 ± 7 days after the last dose to capture potential safety events. Follow-up schedule: survival will be confirmed by telephone monthly in accordance with routine clinical practice at local sites; clinical follow-up every 3 months is recommended for patients discontinuing treatment for reasons other than disease progression.

This study will not alter the established clinical decisions of treating physicians or impose additional treatment risks on patients. All treatment regimens will be administered in accordance with clinical guideline recommendations and individual patient clinical circumstances.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 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). Exclusion Criteria: * 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. * Patients with known hypersensitivity, contraindication or precautionary use to the study treatment agents, their analogues, or other biological products. * Pregnant or lactating females. * 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. * 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.

Primary outcome measure(s)

overall survival — From date of first diagnosis of RAS wild-type metastatic colorectal cancer until date of death from any cause, assessed up to 30 months
Time from the index-date (initial diagnosis of RAS wild-type mCRC) to death from any cause. Patients alive or lost-to-follow-up will be censored at the date of last valid follow-up.
Incremental Cost-Utility Ratio (ICUR) — From date of treatment initiation until date of study completion, death, or loss to follow-up, whichever comes first, assessed up to 30 months
Ratio of incremental direct medical costs versus incremental quality-adjusted life-years (QALYs) between the Panitumumab N01 arm and the cetuximab/cetuximab N01 arm; unit: CNY per QALY. Only costs generated after Panitumumab N01 is listed for national medical reimbursement are included.

Trial sites (1)

Facility	City	Region	Status
Fujian Medical University Union Hospital	Fuzhou	Fujian

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07917429 on ClinicalTrials.gov ↗ ← All trials in China