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NALIRIFOX Plus Targeted Therapy Versus FOLFOX Plus Targeted Therapy as First-line Treatment for Metastatic Colorectal Cancer

ConditionMetastatic Colorectal Cancer (CRC)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Zhongshan Hospital

About this trial

To explore the safety and efficacy of NALIRIFOX plus targeted therapy versus FOLFOX plus targeted therapy as first-line treatment for metastatic colorectal cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥18 years old

Histopathologically confirmed patient with an inoperable metastatic colorectal adenocarcinoma

The unresectable stage of metastatic disease has not received any systemic antitumor therapy

For subjects previously receiving neoadjuvant or adjuvant therapy, the date of first discovery of disease progression must be at least 12 months removed from the date of last administration of neoadjuvant or adjuvant therapy

Disqualifiers

Patients with known MSI-H or dMMR who were evaluated by investigators as suitable for treatment with immune checkpoint inhibitors.

Patients allergic to the investigational drug and its excipients

Underweight (body mass index [BMI]<18.5 kg/m²

Known or suspected central nervous system metastasis

Trial design

Design model

Parallel

Treatments tested in this trial

  • NALIRIFOX plus targeted therapy

    Drug

    Drug: Irinotecan Liposome Irinotecan liposome injection will be administered by an intravenous infusion at the dose of 50 mg/m\^2, d1, 14 days per cycle. Drug: Oxaliplatin 75 mg/m\^2, intravenously infusion, d1, 14 days per cycle. Drug: 5-FU 2400mg/m\^2, intravenous infusion, d1-2, 14 days per cycle. Drug: LV/l-LV 400mg/m\^2 or 200mg/m\^2 , intravenous infusion, d1, 14 days per cycle. Drug: Bevacizumab 5mg/kg, intravenous infusion, d1, 14 days per cycle. Drug: Cetuximab 500mg/m\^2, intravenous infusion, d1, 14 days per cycle.

  • FOLFOX plus targeted therapy

    Drug

    Drug: Oxaliplatin 85 mg/m\^2, intravenously infusion, d1, 14 days per cycle. Drug: 5-FU 2400mg/m\^2, intravenous infusion, d1-2, 14 days per cycle. Drug: LV/l-LV 400mg/m\^2 or 200mg/m\^2 , intravenous infusion, d1, 14 days per cycle. Drug: Bevacizumab 5mg/kg, intravenous infusion, d1, 14 days per cycle. Drug: Cetuximab 500mg/m\^2, intravenous infusion, d1, 14 days per cycle.

Treatment groups

144 Participants
are divided into 2 treatment groups
Group A: NALIRIFOX plus targeted therapyExperimental treatment 1 intervention
Group B: FOLFOX plus targeted therapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

18 month PFS rate

To investigate the preliminary antitumor efficacy of study.

Time frame
Eighteen months after the randomization of research participants

Secondary outcomes

1

Objective response rate

To investigate the preliminary antitumor efficacy of study.

Time frame
From date of randomization until the date of first documented progression、termination of treatment, or date of death from any cause, whichever came first, assessed up to 12 months
2

Disease control rate

To investigate the preliminary antitumor efficacy of study.

Time frame
From date of randomization until the date of first documented progression、termination of treatment, or date of death from any cause, whichever came first, assessed up to 12 months
3

Progression free survival

To investigate the preliminary antitumor efficacy of study.

Time frame
From date of randomization until the date of first documented progression、termination of treatment, or date of death from any cause, whichever came first, assessed up to 12months
4

R0 resection

To assess surgical conversion rates in patients who could be surgically resected.

Time frame
From date of randomization until the date of surgical resection, assessed up to 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Zhongshan Hospital

Lead sponsor

Source ClinicalTrials.gov
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