NCT07917429Not yet recruiting
Real-World Study: Panitumumab N01 vs Cetuximab Plus FOLFOX in First-Line RAS Wild-Type mCRC
A Real-World Study of FOLFOX Combined With Panitumumab N01 Versus Cetuximab as First-Line Treatment for RAS Wild-Type Metastatic Colorectal Cancer
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 610 (estimated)
- First submitted
- 23 Oct 2026
- Start date
- 1 Jan 2027
- Primary completion date
- 1 Mar 2030
- Lead sponsor
- Fujian Medical University Union Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT07917429
What you commit to
- Study type: Observational
- Planned participants: 610
- From 1 Jan 2027 to the primary completion date, 1 Mar 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Patients with known hypersensitivity, contraindication or precautionary use to the study treatment agents, their analogues, or other biological products.
Lab values
- 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.
Other
- 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.
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fujian Medical University Union Hospital | Fuzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.