Metastatic Colorectal Cancer (CRC)Phase 3NCT07309289
NALIRIFOX Plus Targeted Therapy Versus FOLFOX Plus Targeted Therapy as First-line Treatment for Metastatic Colorectal Cancer
A Phase 3 study testing NALIRIFOX plus targeted therapy and FOLFOX plus targeted therapy in people with Metastatic Colorectal Cancer (CRC), run by Shanghai Zhongshan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer (CRC)
- What is being tested?
- NALIRIFOX plus targeted therapy and FOLFOX plus targeted therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 1 Sep 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Zhongshan Hospital
Shanghai
+86-21-64041990
About this study
Official title: NALIRIFOX Plus Targeted Therapy Versus FOLFOX Plus Targeted Therapy as First-line Treatment for Metastatic Colorectal Cancer: a Multicentre, Open-label, Randomised 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.
Read the detailed description
This is a multicentre, open-label, randomised study 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)
- Being tested
- NALIRIFOX plus targeted therapy, FOLFOX plus targeted therapy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NALIRIFOX plus targeted therapyDrug
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 therapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| NALIRIFOX plus targeted therapy | Experimental | NALIRIFOX plus targeted therapy Receives: Drug: NALIRIFOX plus targeted therapy |
| FOLFOX plus targeted therapy | Active comparator | FOLFOX plus targeted therapy Receives: Drug: FOLFOX plus targeted therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
18 month PFS rate
To investigate the preliminary antitumor efficacy of study.
Measured: Eighteen months after the randomization of research participants
Secondary outcomes (5)
Objective response rate
To investigate the preliminary antitumor efficacy of study.
Measured: 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
To investigate the preliminary antitumor efficacy of study.
Measured: 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
To investigate the preliminary antitumor efficacy of study.
Measured: 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
To assess surgical conversion rates in patients who could be surgically resected.
Measured: From date of randomization until the date of surgical resection, assessed up to 12 months
Overall survival
To investigate the preliminary antitumor efficacy of study.
Measured: From date of randomization until the date of death from any cause, assessed up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start1 Jul 2025
- Primary completion1 Mar 2029 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal Cancer (CRC)Studies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tianshu Liu, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07309289
- Sponsor's protocol ID
- CSPC-DEY-CRC-K10
- Status last verified
- Dec 2025
- First submitted
- 15 Dec 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NALIRIFOX Plus Targeted Therapy Versus FOLFOX Plus Targeted Therapy as First-line Treatment for Metastatic Colorectal Cancer: a Multicentre, Open-label, Randomised Trial
- ClinicalTrials.gov ID
- NCT07309289
- Acronym / sponsor ID
- CSPC-DEY-CRC-K10
- Conditions
- Metastatic Colorectal Cancer (CRC)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Mar 2029 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 30 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To explore the safety and efficacy of NALIRIFOX plus targeted therapy versus FOLFOX plus targeted therapy as first-line treatment for metastatic colorectal cancer.
Detailed description
This is a multicentre, open-label, randomised study to explore the safety and efficacy of NALIRIFOX plus targeted therapy versus FOLFOX plus targeted therapy as first-line treatment for metastatic colorectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NALIRIFOX plus targeted therapy | Experimental | Drug: NALIRIFOX plus targeted therapyNALIRIFOX plus targeted therapy |
| FOLFOX plus targeted therapy | Active comparator | Drug: FOLFOX plus targeted therapyFOLFOX plus targeted therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≥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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NALIRIFOX plus targeted therapyDrug: 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. | Drug | NALIRIFOX plus targeted therapy |
| FOLFOX plus targeted therapyDrug: 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. | Drug | FOLFOX plus targeted therapy |
Primary outcome
18 month PFS rate
Time frame: Eighteen months after the randomization of research participants
To investigate the preliminary antitumor efficacy of study.
5 secondary outcomes
Objective response rate
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
Disease control rate
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
Progression free survival
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
R0 resection
Time frame: From date of randomization until the date of surgical resection, assessed up to 12 months
Overall survival
Time frame: From date of randomization until the date of death from any cause, assessed up to 30 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NALIRIFOX plus targeted therapy and FOLFOX plus targeted therapy in people with Metastatic Colorectal Cancer (CRC), run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tianshu Liu, Doctor (+86-21-64041990, liu.tianshu@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
18 month PFS rate (time frame: Eighteen months after the randomization of research participants). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.