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

NCT07309289 | Recruiting Phase 3

• 1 other identifier: CSPC-DEY-CRC-K10
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Metastatic Colorectal Cancer (CRC)

Outcome Measures

Primary Outcomes (1)

• 18 month PFS rate

  To investigate the preliminary antitumor efficacy of study.

  Eighteen months after the randomization of research participants

Secondary Outcomes (5)

• Objective response rate

  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

• Disease control rate

  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

• Progression free survival

  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

• R0 resection

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

• Overall survival

  From date of randomization until the date of death from any cause, assessed up to 30 months

Study Arms (2)

NALIRIFOX plus targeted therapy

EXPERIMENTAL

NALIRIFOX plus targeted therapy

Drug: NALIRIFOX plus targeted therapy

FOLFOX plus targeted therapy

ACTIVE COMPARATOR

FOLFOX plus targeted therapy

Drug: FOLFOX plus targeted therapy

Interventions

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.

NALIRIFOX plus targeted therapy

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.

FOLFOX plus targeted therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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
• The presence of at least 1 measurable lesion that can be evaluated according to the RECIST v1.1 criteria
• ECOG 0\~1
• Normal bone marrow and organ function
• Understand the situation of this study, patients and/or legal representatives voluntarily agree to participate in this study and sign informed consent form

You may not qualify if:

• 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/m\^2
• Known or suspected central nervous system metastasis
• Received irinotecan before enrollment
• Had undergone surgery and other oncologic treatments within the first 4 weeks of enrollment
• Previous treatment-related toxicity didn't return to NCI-CTCAE v5.0 class I or below.
• The use of CYP3A, CYP2C8, and UGT1A1 inhibitors or inducers couldn't be discontinued or were not discontinued within 2 weeks prior to enrollment
• Serious gastrointestinal disorders
• Interstitial lung disease
• Tendency of arterial embolism and massive bleeding within 6 months before enrollment (except surgical bleeding)
• Patients with fluid accumulation that couldn't reach a stable state and small amount of pleural effusion or ascites on imaging without clinical symptoms could be enrolled
• Intestinal obstruction, or a risk of intestinal obstruction in the short term
• Gastrointestinal perforation, intraperitoneal abscess, and fistula
• Any serious or uncontrolled systemic disease, including uncontrolled high blood pressure, heart disease, active bleeding, active viral infection, etc

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Shanghai Zhongshan Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Folfox protocol

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Tianshu Liu, Doctor

CONTACT

+86-21-64041990; liu.tianshu@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: December 30, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: December 30, 2025

Record last verified: 2025-12

Locations

CN (1)