Real-World Study: Panitumumab N01 vs Cetuximab Plus FOLFOX in First-Line RAS Wild-Type mCRC
NCT07917429, Not yet recruiting, Fujian Medical University Union Hospital
Trial 9
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Real-World Study: Panitumumab N01 vs Cetuximab Plus FOLFOX in First-Line RAS Wild-Type mCRC | ClinicalTrials.gov |
| NCT number | NCT07917429 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Enrollment | 610 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Fujian Medical University Union Hospital | ClinicalTrials.gov |
| Conditions | Colorectal Cancer Metastatic | ClinicalTrials.gov |
| Interventions | Panitumumab N01, Cetuximab (EGFR inhibitor) | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-04 | ClinicalTrials.gov |
Registered outcomes 19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | 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. | ClinicalTrials.gov |
| Primary | 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. | ClinicalTrials.gov |
| Secondary | 2-Year Overall Survival Rate | From date of first diagnosis of RAS wild-type metastatic colorectal cancer until date of death from any cause, assessed up to 24 months | Cumulative probability of being alive at 24 complete months after index-date, estimated by the Kaplan-Meier method. All-cause death is the event; subjects who are lost-to-follow-up or still alive before 24-month time-point are censored. | ClinicalTrials.gov |
| Secondary | Real-World Progression-Free Survival | From date of first diagnosis of RAS wild-type metastatic colorectal cancer until date of first documented disease progression or death from any cause, whichever comes first, assessed up to 30 months | Time from index-date to the earliest documented disease progression (per real-world clinical evidence: imaging, pathology, clinical notes indicating PD / new lesion) or death from any cause, whichever occurs first. Censored at last evaluable assessment for patients without events. | ClinicalTrials.gov |
| Secondary | Duration of Treatment | From date of first administration of study drug (panitumumab N01 or cetuximab / cetuximab N01) until date of permanent treatment discontinuation for any cause, assessed up to 30 months | Time from first dose of study drug (Panitumumab N01 / cetuximab / cetuximab N01) to permanent discontinuation of study drug for any reason (disease progression, adverse event, patient preference, economic reason, death). | ClinicalTrials.gov |
| Secondary | Time To Next Treatment | From date of first diagnosis of RAS wild-type metastatic colorectal cancer until date of initiation of next-line systemic anticancer therapy or death from any cause, whichever comes first, assessed up to 30 months | Time from index-date to initiation of next-line systemic anti-tumor therapy or death, whichever occurs first. Maintenance therapy is not counted as next-line treatment. | ClinicalTrials.gov |
| Secondary | Objective Response Rate | From date of first diagnosis of RAS wild-type metastatic colorectal cancer until date of disease progression or initiation of new anticancer therapy, whichever comes first, assessed up to 30 months | Proportion of participants achieving best overall response of Complete Response (CR) or Partial Response (PR) per RECIST 1.1, sustained for at least 4 weeks, from index-date until documented disease progression or initiation of participant's new anti-tumor therapy. | ClinicalTrials.gov |
| Secondary | Complete Response Rate | From date of first diagnosis of RAS wild-type metastatic colorectal cancer until date of disease progression or initiation of new anticancer therapy, whichever comes first, assessed up to 30 months | Proportion of participants achieving best overall Complete Response (CR) per RECIST 1.1, sustained for at least 4 weeks, from index-date until documented disease progression or initiation of participant's new anti-tumor therapy. | ClinicalTrials.gov |
| Secondary | Disease Control Rate | From date of first diagnosis of RAS wild-type metastatic colorectal cancer until date of disease progression or initiation of new anticancer therapy, whichever comes first, assessed up to 30 months | Proportion of participants achieving best overall response of CR, PR or Stable Disease (SD) per RECIST 1.1, sustained for at least 4 weeks, from index-date until documented disease progression or initiation of participant's new anti-tumor therapy | ClinicalTrials.gov |
| Secondary | Early Tumor Shrinkage Rate | At 8 weeks ±7 days after the participant's first study-drug dose | Proportion of participants with ≥30 % reduction in sum of longest diameters of measurable target lesions at Week 8 ± 7 days after participant's first study-drug dose (RECIST 1.1). No minimum duration of response required. | ClinicalTrials.gov |
| Secondary | Depth of Response | From baseline assessment until the time point of maximum tumor shrinkage during the entire treatment period, assessed up to 30 months | Maximum percentage-reduction from baseline in sum of longest diameters of target lesions among participants with tumour shrinkage. Formula: (baseline sum - minimum on-treatment sum of target-lesion longest diameters) / baseline sum × 100 %. | ClinicalTrials.gov |
| Secondary | Conversion Resection Rate | From participant's baseline MDT assessment until completion of participant's curative-intent surgery | Percentage of participants who had MDT-confirmed initially unresectable metastatic colorectal cancer at baseline and subsequently received curative-intent resection of all primary plus metastatic lesions after receiving ≥1 cycle of study treatment. | ClinicalTrials.gov |
| Secondary | Cancer-Specific Survival | From date of first diagnosis of RAS wild-type metastatic colorectal cancer until date of death caused by colorectal cancer or its treatment-related complications, assessed up to 30 months | Time from index-date to death attributable to colorectal cancer or treatment-related complications. Deaths from other causes are treated as competing events; participants lost-to-follow-up or remaining alive are censored. Estimated via Fine-Gray competing-risk model | ClinicalTrials.gov |
| Secondary | Treatment-Emergent Adverse Event (TEAE) Incidence | From participant's first study-drug dose to 28 days ± 7 days after participant's last study-drug dose | Proportion of participants experiencing at least one TEAE (any adverse event newly occurring or worsening from first study-drug dose through 28 days ± 7 days after last study-drug dose), graded per CTCAE 6.0. | ClinicalTrials.gov |
| Secondary | Per-Patient Full-Cycle Direct Medical Costs | From date of treatment initiation until date of study completion, death, or loss to follow-up, whichever comes first, assessed up to 30 months | Per-participant total direct anti-tumour-related medical costs from index-date to death, including targeted-drug cost, chemotherapy cost, pre-medication cost, adjunctive-drug cost, lab-imaging costs, inpatient costs, outpatient costs and adverse-event-management costs. | ClinicalTrials.gov |
| Secondary | Per-Patient Medical-Insurance-Fund Payment Amount | From date of treatment initiation until date of study completion, death, or loss to follow-up, whichever comes first, assessed up to 30 months | Per-participant total amount paid by medical-insurance funds (pooling fund, catastrophic-insurance, medical-assistance, supplementary-enterprise-insurance) | ClinicalTrials.gov |
| Secondary | EQ-5D-5L Health-Utility Value | Assessed at baseline, weekly for the first 2 months of treatment, every 3 months (±7 days) during subsequent treatment, and every 6 months (±14 days) after disease progression, through study completion, up to 30 months | Health-state utility value derived from the Chinese EQ-5D-5L value set, covering mobility, self-care, usual-activities, pain-discomfort, anxiety-depression; score range -0.594 \~ 1.0 (1 = full health, 0 = death; negative values represent states worse-than-death). | ClinicalTrials.gov |
| Secondary | FACT-EGFRI-18 | At baseline within 28 days before the participant's first study-drug dose; weekly for the first 2 months of the participant's treatment; every 3 months ± 7 days thereafter; up to 28 days ± 7 days after the participant's last study-drug dose | Patient-reported 18-item FACT-EGFRI-18 questionnaire evaluating EGFR-inhibitor-associated physical, social-family and functional symptom burden over the prior 7 days; total score and sub-domain scores (physical well-being, social-family well-being, functional well-being). Higher scores represent lower symptom burden and better quality-of-life | ClinicalTrials.gov |
| Secondary | PRO-CTCAE Adverse-Event Outcomes | At participant's baseline; weekly for the first 2 months of the participant's treatment; every 3 months ± 7 days thereafter; up to 28 days ± 7 days after the participant's last study-drug dose | Patient-reported adverse-event frequency and severity collected via PRO-CTCAE questionnaire over prior 7 days. Endpoints include overall AE incidence, frequency-grade distribution and severity-grade distribution of individual symptoms. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)