NCT07309289 NALIRIFOX Plus Targeted Therapy Versus FOLFOX Plus Targeted Therapy as First-line Treatment for Metastatic Colorectal Cancer
| NCT ID | NCT07309289 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Shanghai Zhongshan Hospital |
| Condition | Metastatic Colorectal Cancer (CRC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 144 participants |
| Start Date | 2025-07-01 |
| Primary Completion | 2029-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 144 participants in total. It began in 2025-07-01 with a primary completion date of 2029-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * ≥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 Exclusion Criteria: * 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 * Have had other malignancies within the past 5 years or currently, except cured cervical carcinoma in situ, uterine carcinoma in situ, and non-melanoma skin cancer * Patients of childbearing age who refuse to take contraceptives, women who are pregnant or breastfeeding * The researchers didn't consider it appropriate to participate in this study
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07309289 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Metastatic Colorectal Cancer (CRC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07309289 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 144 participants.
Is NCT07309289 currently recruiting?
Yes, NCT07309289 is actively recruiting participants. Contact the research team at liu.tianshu@zs-hospital.sh.cn for enrollment information.
Where is the NCT07309289 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07309289 clinical trial?
NCT07309289 is sponsored by Shanghai Zhongshan Hospital. The trial plans to enroll 144 participants.
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