Colo-rectal CancerPhase 2NCT07515963
FULIRI Plus Targeted Therapy for First-line Conversion Therapy of Colorectal Cancer Liver Metastases.
A Phase 2 study testing FULIRI combination targeted therapy in people with Colo-rectal Cancer, run by Zhongnan Hospital at 1 site in China.
Trial summary
This study is a single-center, prospective, randomized, single-arm phase II clinical trial designed to evaluate the safety and efficacy of FULIRI chemotherapy regimen combined with targeted therapy (bevacizumab/cetuximab) as first-line conversion therapy for colorectal cancer with liver metastases. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colo-rectal Cancer
- What is being tested?
- FULIRI combination targeted therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to 1 Feb 2028
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) Age 18-75 years; (2) Histologically confirmed colorectal adenocarcinoma; (3) Synchronous liver metastasis of colorectal cancer, or liver metastasis occurring after curative surgery for colorectal cancer, and no prior systemic anti-tumor treatment (including but not limited to systemic chemotherapy, molecular targeted therapy, immunotherapy, biological therapy, and other investigational drugs) after diagnosis of liver metastasis; (4) Liver metastasis deemed unresectable by MDT assessment, or potentially resectable but with a CRS score ≥3; (5) For patients who have received neoadjuvant or adjuvant therapy for colorectal cancer, the date of first diagnosis of liver metastasis must be at least 6 months after the last dose of neoadjuvant or adjuvant therapy; (6) At least one measurable target lesion on CT scan, assessable according to RECIST v1.1 criteria; (7) ECOG performance status 0-2; (8) Good organ function, without severe comorbidities of the heart, liver, lungs, kidneys, brain, etc.; (9) Blood routine: HGB ≥90 g/L, WBC >3.5 × 10^9/L (NEU ≥1.5 × 10^9/L), PLT ≥90 × 10^9/L; Liver function: ALT or AST ≤2.5 times the upper limit of normal (ULN); Bilirubin ≤1.5 × ULN; Renal function: serum creatinine ≤1.5 × ULN; (10) Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days before starting the study medication and be willing to use a medically approved highly effective contraceptive method during the study and for 3 months after the last dose of study medication; male subjects with partners of childbearing potential must agree to use effective contraception during the study and for 3 months after the last dose of study medication.
- The subject has given informed consent and signed the informed consent form, and is willing and able to comply with the planned visits, study treatment, laboratory tests, and other study procedures.
Who cannot join
- (1) Pathological diagnosis reveals the presence of neuroendocrine tumor, squamous cell carcinoma, or adenosquamous carcinoma components; (2) Presence of conditions requiring emergency treatment, such as bowel obstruction, bowel perforation, or bleeding; (3) Presence of multiple metastases in sites other than the liver (excluding localized lung metastases (≤2) or localized retroperitoneal lymph node metastases, provided the investigator assesses that the patient has a chance of achieving NED status); (4) Patients with known microsatellite instability-high (MSI-H) or mismatch repair deficiency (dMMR) who are deemed suitable for immunotherapy with immune checkpoint inhibitors by the investigator; (5) Previous treatment with irinotecan; (6) Underweight (Body Mass Index [BMI] < 18 kg/m2); (7) Concurrent or previous history of other malignancies besides cervical carcinoma in situ and basal cell carcinoma of the skin; (8) Concurrent severe infection or active pulmonary tuberculosis; (9) History of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation; (10) Patients with hepatitis B, if hepatitis B DNA exceeds 1000 copies/mL, should be excluded; patients with hepatitis C, if hepatitis C RNA is positive, should be excluded; (11) Received surgery or other anti-tumor treatments (including chemotherapy, radiotherapy, investigational treatments, etc.) within 4 weeks prior to enrollment; (12) Concurrent severe gastrointestinal dysfunction (> Grade I according to NCI-CTCAE v5.0, such as intestinal inflammation or diarrhea); (13) Presence of conditions within the past 6 months that contraindicate targeted therapy, such as arterial embolism, severe bleeding, or bowel perforation (excluding bleeding caused by surgery); (14) Concurrent severe or uncontrolled systemic diseases, including but not limited to hypertension (systolic blood pressure consistently above 150 mmHg, diastolic blood pressure consistently above 95 mmHg), diabetes, heart disease, etc.; (15) Patients who cannot tolerate this study or who may be allergic to the medications used in this study; (16) Patients with cognitive impairment or co-existing severe mental disorders, who are judged by the investigator to have poor adherence to chemotherapy; or other situations deemed unsuitable for participation in clinical research by the investigator.
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
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071
Yongchang Wei, +862767812787, weiyongchang@whu.edu.cn
About this study
Official title: A Phase II Clinical Study of FULIRI Regimen Chemotherapy Combined With Targeted Therapy for First-line Conversion Treatment of Colorectal Cancer Liver Metastases.
This study is a single-center, prospective, randomized, single-arm phase II clinical trial designed to evaluate the safety and efficacy of FULIRI chemotherapy regimen combined with targeted therapy (bevacizumab/cetuximab) as first-line conversion therapy for colorectal cancer with liver metastases. Eligible patients with colorectal cancer and liver metastases, after signing informed consent, received FULIRI chemotherapy combined with bevacizumab/cetuximab targeted therapy. Efficacy was assessed after every four treatment cycles, followed by multidisciplinary team (MDT) discussion regarding potential surgical resection, ablation, or stereotactic radiotherapy. The primary endpoint was the objective response rate (ORR), and secondary endpoints included: disease control rate (DCR), R0 resection rate of liver metastases, progression-free survival (PFS), 3-year/5-year survival rates, and the incidence of acute toxicities of any grade and grades 3/4.
Read the detailed description
Irinotecan (IRI, also known as CPT-11) is an important component in chemotherapy for metastatic colorectal cancer. It induces single-strand DNA damage and blocks DNA replication. After traditional irinotecan administration, both the parent drug and its active metabolite SN-38 exist in two forms: active lactone and carboxylate. The lactone ring structure is unstable in neutral and alkaline solutions. Under physiological pH conditions, the active lactone rapidly hydrolyzes and becomes inactive as a carboxylate, thus reducing its efficacy, which limits its clinical application. The most significant adverse events in patients receiving irinotecan treatment are diarrhea, nausea, vomiting, and neutropenia; in patients receiving irinotecan monotherapy, the main causes of treatment-related death are neutropenic infection, grade 4 diarrhea, and fatigue. Shijiazhuang Pharmaceutical Group's first generic irinotecan liposome is a new formulation that improves upon traditional irinotecan. It encapsulates the active substance irinotecan in liposomes, utilizing the enhanced permeability and retention (EPR) effect to specifically target the tumor area. This increases the affinity of the drug to cancer cells, overcomes drug resistance, reduces the dosage, improves efficacy, and reduces toxic side effects, thereby mitigating the limitations of irinotecan in clinical use.
Currently, there is a lack of research data on irinotecan liposome combined with 5-FU/LV and targeted therapy in patients with advanced metastatic colorectal cancer. Because irinotecan liposome cannot directly replace the dosage of conventional irinotecan, we are conducting a phase II clinical study for first-line conversion therapy in patients with colorectal cancer liver metastases. This study aims to explore the safety and efficacy of irinotecan liposome combined with 5-FU/LV + bevacizumab or cetuximab, thus providing more treatment options for patients with advanced metastatic colorectal cancer.
- Conditions
- Colo-rectal Cancer
- Being tested
- FULIRI combination targeted therapy
- Keywords
- Colorectal cancer, Liver metastasis, FULIRI
- Medical subject headings
- Colonic Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FULIRI combination targeted therapyDrug
Chemotherapy regimen FULIRI: Irinotecan liposome 70 mg/m2; leucovorin CF 400 mg/m2, d1, iv drop; 5-FU 400 mg/m2, d1, iv drop; 5-FU 2400 mg/m2, d1, CIV 46-48h; repeated every 2 weeks.
Combined targeted therapy: Based on tumor gene analysis results, investigators may choose to combine bevacizumab (5 mg/kg, iv drop, d1) or cetuximab (500 mg/m2, iv drop, d1), repeated every 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Colorectal cancer patients with liver metastases who meet the inclusion criteria will sign an informed consent form and receive FULIRI chemotherapy combined with bevacizumab/cetuximab targeted therapy. Treatment efficacy will be assessed after every four cycles of treatment. After multidisciplinary team (MDT) discussion, a decision will be made regarding whether to proceed with surgery, ablation, stereotactic radiotherapy, or other treatments. Chemotherapy combined with targeted therapy will continue for a maximum of 12 cycles, until the possibility of curative surgery/ablation or other local treatment arises, disease progression occurs, intolerable toxicity develops, or the patient withdraws informed consent (whichever comes first). The adjuvant and maintenance treatment regimens after curative surgery or achieving NED (no evidence of disease) status will be determined by the investigator. Receives: Drug: FULIRI combination targeted therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Objective response rate (ORR), also known as overall response rate or efficacy rate, refers to the proportion of patients in a clinical trial whose tumor volume shrinks to a predetermined value and remains at that level for a minimum specified duration.
Measured: 1 year
Secondary outcomes (4)
Disease Control Rate (DCR)
DCR refers to the percentage of patients who achieve complete remission (CR), partial remission (PR), or stable disease (SD) after receiving a certain anti-tumor treatment, out of the total number of evaluable cases.
Measured: 3 years
R0 resection rate of liver metastases
The proportion of surgical patients who achieve an R0 resection. R0 resection: All gross disease has been removed, and microscopic examination reveals all surgical margins free of tumor.
Measured: 1 year
Progression-free survival (PFS)
PFS is defined as the time period from the start of treatment until disease progression or death.
Measured: 3 years
Overall survival (OS)
The time interval between the date of randomization to the date of death. If the patient has been alive, the time until the last follow-up is taken as the overall survival period.
Measured: 3/5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colo-rectal CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongnan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07515963
- Sponsor's protocol ID
- 2025073
- Status last verified
- Mar 2026
- First submitted
- 30 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study of FULIRI Regimen Chemotherapy Combined With Targeted Therapy for First-line Conversion Treatment of Colorectal Cancer Liver Metastases.
- ClinicalTrials.gov ID
- NCT07515963
- Acronym / sponsor ID
- 2025073
- Conditions
- Colo-rectal Cancer
- Keywords
- Colorectal cancer, Liver metastasis, FULIRI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Zhongnan HospitalUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 7 Apr 2026 (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.
This study is a single-center, prospective, randomized, single-arm phase II clinical trial designed to evaluate the safety and efficacy of FULIRI chemotherapy regimen combined with targeted therapy (bevacizumab/cetuximab) as first-line conversion therapy for colorectal cancer with liver metastases. Eligible patients with colorectal cancer and liver metastases, after signing informed consent, received FULIRI chemotherapy combined with bevacizumab/cetuximab targeted therapy. Efficacy was assessed after every four treatment cycles, followed by multidisciplinary team (MDT) discussion regarding potential surgical resection, ablation, or stereotactic radiotherapy. The primary endpoint was the objective response rate (ORR), and secondary endpoints included: disease control rate (DCR), R0 resection rate of liver metastases, progression-free survival (PFS), 3-year/5-year survival rates, and the incidence of acute toxicities of any grade and grades 3/4.
Detailed description
Irinotecan (IRI, also known as CPT-11) is an important component in chemotherapy for metastatic colorectal cancer. It induces single-strand DNA damage and blocks DNA replication. After traditional irinotecan administration, both the parent drug and its active metabolite SN-38 exist in two forms: active lactone and carboxylate. The lactone ring structure is unstable in neutral and alkaline solutions. Under physiological pH conditions, the active lactone rapidly hydrolyzes and becomes inactive as a carboxylate, thus reducing its efficacy, which limits its clinical application. The most significant adverse events in patients receiving irinotecan treatment are diarrhea, nausea, vomiting, and neutropenia; in patients receiving irinotecan monotherapy, the main causes of treatment-related death are neutropenic infection, grade 4 diarrhea, and fatigue. Shijiazhuang Pharmaceutical Group's first generic irinotecan liposome is a new formulation that improves upon traditional irinotecan. It encapsulates the active substance irinotecan in liposomes, utilizing the enhanced permeability and retention (EPR) effect to specifically target the tumor area. This increases the affinity of the drug to cancer cells, overcomes drug resistance, reduces the dosage, improves efficacy, and reduces toxic side effects, thereby mitigating the limitations of irinotecan in clinical use.
Currently, there is a lack of research data on irinotecan liposome combined with 5-FU/LV and targeted therapy in patients with advanced metastatic colorectal cancer. Because irinotecan liposome cannot directly replace the dosage of conventional irinotecan, we are conducting a phase II clinical study for first-line conversion therapy in patients with colorectal cancer liver metastases. This study aims to explore the safety and efficacy of irinotecan liposome combined with 5-FU/LV + bevacizumab or cetuximab, thus providing more treatment options for patients with advanced metastatic colorectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: FULIRI combination targeted therapyColorectal cancer patients with liver metastases who meet the inclusion criteria will sign an informed consent form and receive FULIRI chemotherapy combined with bevacizumab/cetuximab targeted therapy. Treatment efficacy will be assessed after every four cycles of treatment. After multidisciplinary team (MDT) discussion, a decision will be made regarding whether to proceed with surgery, ablation, stereotactic radiotherapy, or other treatments. Chemotherapy combined with targeted therapy will continue for a maximum of 12 cycles, until the possibility of curative surgery/ablation or other local treatment arises, disease progression occurs, intolerable toxicity develops, or the patient withdraws informed consent (whichever comes first). The adjuvant and maintenance treatment regimens after curative surgery or achieving NED (no evidence of disease) status will be determined by the investigator. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- (1) Age 18-75 years; (2) Histologically confirmed colorectal adenocarcinoma; (3) Synchronous liver metastasis of colorectal cancer, or liver metastasis occurring after curative surgery for colorectal cancer, and no prior systemic anti-tumor treatment (including but not limited to systemic chemotherapy, molecular targeted therapy, immunotherapy, biological therapy, and other investigational drugs) after diagnosis of liver metastasis; (4) Liver metastasis deemed unresectable by MDT assessment, or potentially resectable but with a CRS score ≥3; (5) For patients who have received neoadjuvant or adjuvant therapy for colorectal cancer, the date of first diagnosis of liver metastasis must be at least 6 months after the last dose of neoadjuvant or adjuvant therapy; (6) At least one measurable target lesion on CT scan, assessable according to RECIST v1.1 criteria; (7) ECOG performance status 0-2; (8) Good organ function, without severe comorbidities of the heart, liver, lungs, kidneys, brain, etc.; (9) Blood routine: HGB ≥90 g/L, WBC >3.5 × 10^9/L (NEU ≥1.5 × 10^9/L), PLT ≥90 × 10^9/L; Liver function: ALT or AST ≤2.5 times the upper limit of normal (ULN); Bilirubin ≤1.5 × ULN; Renal function: serum creatinine ≤1.5 × ULN; (10) Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days before starting the study medication and be willing to use a medically approved highly effective contraceptive method during the study and for 3 months after the last dose of study medication; male subjects with partners of childbearing potential must agree to use effective contraception during the study and for 3 months after the last dose of study medication.
- The subject has given informed consent and signed the informed consent form, and is willing and able to comply with the planned visits, study treatment, laboratory tests, and other study procedures.
Key exclusion criteria (1 listed)
- (1) Pathological diagnosis reveals the presence of neuroendocrine tumor, squamous cell carcinoma, or adenosquamous carcinoma components; (2) Presence of conditions requiring emergency treatment, such as bowel obstruction, bowel perforation, or bleeding; (3) Presence of multiple metastases in sites other than the liver (excluding localized lung metastases (≤2) or localized retroperitoneal lymph node metastases, provided the investigator assesses that the patient has a chance of achieving NED status); (4) Patients with known microsatellite instability-high (MSI-H) or mismatch repair deficiency (dMMR) who are deemed suitable for immunotherapy with immune checkpoint inhibitors by the investigator; (5) Previous treatment with irinotecan; (6) Underweight (Body Mass Index [BMI] < 18 kg/m2); (7) Concurrent or previous history of other malignancies besides cervical carcinoma in situ and basal cell carcinoma of the skin; (8) Concurrent severe infection or active pulmonary tuberculosis; (9) History of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation; (10) Patients with hepatitis B, if hepatitis B DNA exceeds 1000 copies/mL, should be excluded; patients with hepatitis C, if hepatitis C RNA is positive, should be excluded; (11) Received surgery or other anti-tumor treatments (including chemotherapy, radiotherapy, investigational treatments, etc.) within 4 weeks prior to enrollment; (12) Concurrent severe gastrointestinal dysfunction (> Grade I according to NCI-CTCAE v5.0, such as intestinal inflammation or diarrhea); (13) Presence of conditions within the past 6 months that contraindicate targeted therapy, such as arterial embolism, severe bleeding, or bowel perforation (excluding bleeding caused by surgery); (14) Concurrent severe or uncontrolled systemic diseases, including but not limited to hypertension (systolic blood pressure consistently above 150 mmHg, diastolic blood pressure consistently above 95 mmHg), diabetes, heart disease, etc.; (15) Patients who cannot tolerate this study or who may be allergic to the medications used in this study; (16) Patients with cognitive impairment or co-existing severe mental disorders, who are judged by the investigator to have poor adherence to chemotherapy; or other situations deemed unsuitable for participation in clinical research by the investigator.
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 |
|---|---|---|
| FULIRI combination targeted therapyChemotherapy regimen FULIRI: Irinotecan liposome 70 mg/m2; leucovorin CF 400 mg/m2, d1, iv drop; 5-FU 400 mg/m2, d1, iv drop; 5-FU 2400 mg/m2, d1, CIV 46-48h; repeated every 2 weeks. Combined targeted therapy: Based on tumor gene analysis results, investigators may choose to combine bevacizumab (5 mg/kg, iv drop, d1) or cetuximab (500 mg/m2, iv drop, d1), repeated every 2 weeks. | Drug | Experimental Group |
Primary outcome
Objective Response Rate (ORR)
Time frame: 1 year
Objective response rate (ORR), also known as overall response rate or efficacy rate, refers to the proportion of patients in a clinical trial whose tumor volume shrinks to a predetermined value and remains at that level for a minimum specified duration.
4 secondary outcomes
Disease Control Rate (DCR)
Time frame: 3 years
R0 resection rate of liver metastases
Time frame: 1 year
Progression-free survival (PFS)
Time frame: 3 years
Overall survival (OS)
Time frame: 3/5 years
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 7 Apr 2026.
- Individual participant dataSharing planned: No
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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 2 study testing FULIRI combination targeted therapy in people with Colo-rectal Cancer, run by Zhongnan 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 2 inclusion and 1 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: opening soon, as of the sponsor's last update on 7 Apr 2026. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Yongchang Wei (+8617771886922, weiyongchang@whu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: 1 year). 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 7 Apr 2026.