Metastatic Colorectal CancerPhase 2NCT07559760
New Second-Line Combo Therapy for MSS Metastatic Colorectal Cancer
A Phase 2 study testing Levofolinic Acid + 5-FU continuous infusion + irinotecan HCl liposome ± cetuximab/bevacizumab in people with Metastatic Colorectal Cancer, run by The First Hospital of Jilin University at 1 site in China.
Trial summary
This is a single-center, single-arm study designed to evaluate the efficacy and safety of second-line treatment in patients with advanced colorectal cancer (those who have progressed on or are intolerant to first-line oxaliplatin-based regimens with or without targeted therapy) receiving Levofolinic Acid + 5-FU… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Levofolinic Acid + 5-FU continuous infusion + irinotecan HCl liposome ± cetuximab/bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2025to 31 May 2029
- 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
- Male or female, aged 18-75 years.
- Histologically or cytologically confirmed colorectal adenocarcinoma.
- Unresectable, MSS-type metastatic colorectal cancer that has failed or is intolerant to first-line standard oxaliplatin plus fluoropyrimidine ± targeted therapy.
- Failure definition: progression during or within 3 months after completing first-line oxaliplatin/fluoropyrimidine ± targeted therapy.
- Adjuvant setting: progression/recurrence during or within 6 months of completing adjuvant oxaliplatin-based chemotherapy/chemoradiation counts as first-line failure.
- At least one measurable lesion by RECIST 1.1.
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- ECOG performance status 0-1.
- Expected survival ≥ 3 months.
- Adequate organ function within 14 days before enrollment (no transfusion or growth-factor support):
- Hematology: Hb ≥ 90 g/L; WBC ≥ 3.0 × 10⁹/L; ANC ≥ 1.5 × 10⁹/L; PLT ≥ 90 × 10⁹/L.
- Coagulation: INR ≤ 1.5 × ULN; APTT ≤ 1.5 × ULN (stable anticoagulation at therapeutic range allowed).
- Renal: Creatinine clearance ≥ 50 mL/min (Cockcroft-Gault).
- Hepatic:
- No liver mets: TBIL ≤ 1.5 × ULN, ALT ≤ 2.5 × ULN, AST ≤ 2.5 × ULN.
- Liver mets: TBIL ≤ 2 × ULN, ALT ≤ 5 × ULN, AST ≤ 5 × ULN.
- Cardiac: LVEF ≥ 50 %.
- Voluntary written informed consent; willing and able to comply with study procedures and follow-up.
- WOCBP must have a negative serum/urine pregnancy test within 3 days before first study-dose (Cycle 1 Day 1).
- All subjects (men and women) with reproductive potential must use a highly effective contraceptive method (annual failure rate < 1 %) from screening until 120 days after the last dose of investigational product or 180 days after the last chemotherapy dose, whichever is later.
Who cannot join
- Prior exposure to topoisomerase-I inhibitors or their analogues in first-line therapy.
- Documented hypersensitivity to any study drug or its excipients.
- Pregnant or breast-feeding women.
- Toxicities from prior therapy not resolved to CTCAE v5.0 Grade ≤ 1 (except alopecia or other toxicities deemed by the investigator to pose no safety risk).
- Any anti-cancer therapy (chemotherapy, radiotherapy, biologics, targeted therapy, immunotherapy, etc.) within 4 weeks before first study-dose; major surgery (excluding biopsy) within 4 weeks that has not fully healed.
- Severe psychiatric or psychological disorders that could compromise compliance.
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- Clinically significant cardiovascular disease:
- Severe/unstable angina, symptomatic congestive heart failure (NYHA ≥ II), clinically significant arrhythmia requiring treatment, arterial thrombosis, acute coronary syndrome, MI, cerebrovascular accident (including TIA) or other Grade ≥ 3 CV event within 6 months prior to first dose.
- QTcF ≥ 450 ms (men) or ≥ 470 ms (women) on resting 12-lead ECG.
- Infection-related:
- Active infection or unexplained fever > 38.5 °C on screening or dosing day (tumor fever allowed at investigator's discretion).
- Serious infection (CTCAE Grade 3, e.g., pneumonia, bacteremia) requiring hospitalization within 4 weeks.
- Active pulmonary inflammation on baseline imaging or need for systemic antibiotics (prophylactic antibiotics permitted).
- Known HIV-positive, active hepatitis B, or hepatitis C:
- HBsAg or HBcAb positive: HBV DNA must be ≤ 2.5 × 10³ copies/mL (or ≤ 500 IU/mL, or below LLoQ); HBsAg(+) subjects must receive anti-HBV prophylaxis throughout study treatment.
- HCV-seropositive allowed only if HCV RNA negative (or below LLoQ).
- History or current evidence of leptomeningeal metastases. Active brain metastases: untreated and/or symptomatic, or requiring corticosteroids or anticonvulsants. Subjects treated with surgery or radiotherapy may enter if imaging ≥ 4 weeks shows stable CNS disease, symptoms have resolved, no corticosteroids for ≥ 2 weeks, and acute toxicities have recovered.
- Other severe uncontrolled disorders (e.g., frequent seizures, hepatic failure).
- Other malignancies within 5 years, except adequately treated basal-cell carcinoma of skin or cervical carcinoma in situ.
- Participation in another clinical drug trial within 4 weeks or less than 5 half-lives of the previous investigational agent, whichever is longer.
- Any social or medical condition that, in the investigator's opinion, could interfere with informed consent, study participation, or interpretation of results.
- Patients deemed by the investigator to be unsuitable for enrollment.
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
The First Hospital of Jilin University
Changchun, Jilin
Chang Wang, 15804302610, wangchang@jlu.edu.cn
About this study
Official title: A Prospective Study of Levoleucovorin/5-FU Co-Infusion Combined With Liposomal Irinotecan ±Cetuximab/Bevacizumab as Second-Line Therapy for MSS Metastatic Colorectal Cancer
This is a single-center, single-arm study designed to evaluate the efficacy and safety of second-line treatment in patients with advanced colorectal cancer (those who have progressed on or are intolerant to first-line oxaliplatin-based regimens with or without targeted therapy) receiving Levofolinic Acid + 5-FU continuous infusion combined with irinotecan hydrochloride liposome ± cetuximab/bevacizumab. Approximately 30 patients will be enrolled.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Levofolinic Acid + 5-FU continuous infusion + irinotecan HCl liposome ± cetuximab/bevacizumab
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levofolinic Acid + 5-FU continuous infusion + irinotecan HCl liposome ± cetuximab/bevacizumabDrug
Levofolinic Acid + 5-FU continuous infusion + irinotecan HCl liposome ± cetuximab/bevacizumab
- Irinotecan HCl liposome 70 mg/m² IV over 90 min, Day 1, every 2 weeks
- UGT1A1*28 7/7 homozygotes: start at 50 mg/m²; escalate to 70 mg/m² from cycle 2 if well tolerated.
- Premedication per liposomal irinotecan label.
- Levofolinic Acid 200 mg/m² + 5-FU 2 400 mg/m², both placed in the same ambulatory pump and infused continuously over 46-48 h starting Day 1.
- Targeted agent (physician's choice):
- Bevacizumab 5 mg/kg IV, Day 1, every 2 weeks, or
- Cetuximab 500 mg/m² IV, Day 1, every 2 weeks, or 400 mg/m² first dose then 250 mg/m² weekly.
Liposomal irinotecan is given for a maximum of 12 cycles until progression or unacceptable toxicity.
Upon investigator decision, patients may switch to maintenance: Levofolinic Acid + 5-FU continuous infusion ± bevacizumab/cetuximab.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Treatment Regimen Levofolinic Acid + 5-FU continuous infusion + irinotecan HCl liposome ± cetuximab/bevacizumab
1. Irinotecan HCl liposome 70 mg/m² IV over 90 min, Day 1, every 2 weeks
* UGT1A1*28 7/7 homozygotes: start at 50 mg/m²; escalate to 70 mg/m² from cycle 2 if well tolerated.
* Premedication per liposomal irinotecan label.
2. Levofolinic Acid 200 mg/m² + 5-FU 2 400 mg/m², both placed in the same ambulatory pump and infused continuously over 46-48 h starting Day 1.
3. Targeted agent (physician's choice):
* Bevacizumab 5 mg/kg IV, Day 1, every 2 weeks, or
* Cetuximab 500 mg/m² IV, Day 1, every 2 weeks, or 400 mg/m² first dose then 250 mg/m² weekly.
Liposomal irinotecan is given for a maximum of 12 cycles until progression or unacceptable toxicity.
Upon investigator decision, patients may switch to maintenance: Levofolinic Acid + 5-FU continuous infusion ± bevacizumab/cetuximab. Receives: Drug: Levofolinic Acid + 5-FU continuous infusion + irinotecan HCl liposome ± cetuximab/bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
mPFS
median Progression Free Survival.It is defined as the time from enrollment to the date of first documented tumor progression (assessed according to RECIST 1.1 criteria, regardless of whether treatment is continued) or the date of death from any cause, whichever occurs first.
Measured: 42 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start1 Nov 2025
- Primary completion31 May 2027 (estimated)
- Study completion31 May 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 CancerStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07559760
- Sponsor's protocol ID
- 25K445-001
- Status last verified
- Nov 2025
- First submitted
- 24 Apr 2026
- Last updated
- 30 Apr 2026
- Results posted
- 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 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Levoleucovorin/5-FU Co-Infusion Combined With Liposomal Irinotecan ±Cetuximab/Bevacizumab as Second-Line Therapy for MSS Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT07559760
- Acronym / sponsor ID
- 25K445-001
- Conditions
- Metastatic Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 30 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 is a single-center, single-arm study designed to evaluate the efficacy and safety of second-line treatment in patients with advanced colorectal cancer (those who have progressed on or are intolerant to first-line oxaliplatin-based regimens with or without targeted therapy) receiving Levofolinic Acid + 5-FU continuous infusion combined with irinotecan hydrochloride liposome ± cetuximab/bevacizumab. Approximately 30 patients will be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Drug: Levofolinic Acid + 5-FU continuous infusion + irinotecan HCl liposome ± cetuximab/bevacizumabTreatment Regimen Levofolinic Acid + 5-FU continuous infusion + irinotecan HCl liposome ± cetuximab/bevacizumab 1. Irinotecan HCl liposome 70 mg/m² IV over 90 min, Day 1, every 2 weeks * UGT1A1*28 7/7 homozygotes: start at 50 mg/m²; escalate to 70 mg/m² from cycle 2 if well tolerated. * Premedication per liposomal irinotecan label. 2. Levofolinic Acid 200 mg/m² + 5-FU 2 400 mg/m², both placed in the same ambulatory pump and infused continuously over 46-48 h starting Day 1. 3. Targeted agent (physician's choice): * Bevacizumab 5 mg/kg IV, Day 1, every 2 weeks, or * Cetuximab 500 mg/m² IV, Day 1, every 2 weeks, or 400 mg/m² first dose then 250 mg/m² weekly. Liposomal irinotecan is given for a maximum of 12 cycles until progression or unacceptable toxicity. Upon investigator decision, patients may switch to maintenance: Levofolinic Acid + 5-FU continuous infusion ± bevacizumab/cetuximab. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Male or female, aged 18-75 years.
- Histologically or cytologically confirmed colorectal adenocarcinoma.
- Unresectable, MSS-type metastatic colorectal cancer that has failed or is intolerant to first-line standard oxaliplatin plus fluoropyrimidine ± targeted therapy.
- At least one measurable lesion by RECIST 1.1.
- ECOG performance status 0-1.
Key exclusion criteria (22 listed)
- Prior exposure to topoisomerase-I inhibitors or their analogues in first-line therapy.
- Documented hypersensitivity to any study drug or its excipients.
- Pregnant or breast-feeding women.
- Toxicities from prior therapy not resolved to CTCAE v5.0 Grade ≤ 1 (except alopecia or other toxicities deemed by the investigator to pose no safety risk).
- Any anti-cancer therapy (chemotherapy, radiotherapy, biologics, targeted therapy, immunotherapy, etc.) within 4 weeks before first study-dose; major surgery (excluding biopsy) within 4 weeks that has not fully healed.
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 |
|---|---|---|
| Levofolinic Acid + 5-FU continuous infusion + irinotecan HCl liposome ± cetuximab/bevacizumabLevofolinic Acid + 5-FU continuous infusion + irinotecan HCl liposome ± cetuximab/bevacizumab 1. Irinotecan HCl liposome 70 mg/m² IV over 90 min, Day 1, every 2 weeks * UGT1A1*28 7/7 homozygotes: start at 50 mg/m²; escalate to 70 mg/m² from cycle 2 if well tolerated. * Premedication per liposomal irinotecan label. 2. Levofolinic Acid 200 mg/m² + 5-FU 2 400 mg/m², both placed in the same ambulatory pump and infused continuously over 46-48 h starting Day 1. 3. Targeted agent (physician's choice): * Bevacizumab 5 mg/kg IV, Day 1, every 2 weeks, or * Cetuximab 500 mg/m² IV, Day 1, every 2 weeks, or 400 mg/m² first dose then 250 mg/m² weekly. Liposomal irinotecan is given for a maximum of 12 cycles until progression or unacceptable toxicity. Upon investigator decision, patients may switch to maintenance: Levofolinic Acid + 5-FU continuous infusion ± bevacizumab/cetuximab. | Drug | Experimental Arm |
Primary outcome
mPFS
Time frame: 42 months
median Progression Free Survival.It is defined as the time from enrollment to the date of first documented tumor progression (assessed according to RECIST 1.1 criteria, regardless of whether treatment is continued) or the date of death from any cause, whichever occurs first.
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 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 Levofolinic Acid + 5-FU continuous infusion + irinotecan HCl liposome ± cetuximab/bevacizumab in people with Metastatic Colorectal Cancer, run by The First Hospital of Jilin University 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 19 inclusion and 22 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 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 Chang Wang (15804302610, wangchang@jlu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mPFS (time frame: 42 months). 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 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.