Colorectal CancerPhase 2NCT07123441
A Study on the Efficacy and Safety of Irinotecan Liposome (II), 5-FU/LV in Combination With Bevacizumab for the Treatment of Advanced Colorectal Cancer
A Phase 2 study testing Bevacizumab,Irinotecan liposome (II),5-FU/LV in people with Colorectal Cancer, run by Sanjun Cai at 1 site in China.
Trial summary
This is a single-arm, open-label clinical trial designed to evaluate the efficacy and safety of irinotecan liposome (II), 5-FU/LV in combination with bevacizumab for the treatment of advanced colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Bevacizumab,Irinotecan liposome (II),5-FU/LV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 1 Sep 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
- Aged 18-75 years, no gender restrictions;
- Patients with pathologically confirmed, unresectable advanced colorectal cancer;
- According to the RECIST 1.1 criteria, patients must have at least one measurable target lesion;
- ECOG performance status: 0-1 points;
- Expected survival period ≥3 months;
- Good major organ function, i.e., relevant laboratory parameters within 14 days prior to randomization meet the following requirements:
- Complete blood count (no blood transfusion or use of leukocyte or platelet-enhancing agents within 14 days prior to screening): hemoglobin > 90 g/L; neutrophil count > 1.5 × 10⁹/L; platelet count > 100 × 10⁹/L;(2) Biochemical tests: total bilirubin ≤ 1.5×ULN (upper limit of normal); alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2×ULN; if liver metastasis is present, ALT and AST ≤ 5×ULN; endogenous creatinine clearance ≥ 60 ml/min (Cockcroft-Gault formula); (3) Cardiac Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) ≥ 50%.
- 7. Any damage caused by other treatments has recovered; 8. The subject voluntarily participates in this study, has signed an informed consent form, has good compliance, and cooperates with follow-up.
Who cannot join
- Patients who have had other malignant tumors within the past 5 years (excluding cured in situ carcinomas and basal cell skin carcinomas);
- Patients who have previously received irinotecan treatment;
- Known allergies to the study drug or its related components;
- Tumor tissue confirmed by immunohistochemistry to be dMMR status, or confirmed by next-generation sequencing (NGS)/polymerase chain reaction (PCR) to be MSI-H status;
- Confirmed by next-generation sequencing (NGS)/polymerase chain reaction (PCR) to have BRAF V600E mutation;
- Participated in other drug clinical trials within four weeks prior to enrollment;
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- Presence of significant gastrointestinal abnormalities during the screening period that, in the investigator's judgment, may affect drug intake, transport, or absorption (e.g., inability to swallow, chronic diarrhea, intestinal obstruction, post-small bowel resection, or total gastrectomy); or history of gastrointestinal perforation and/or fistula; history of peptic ulcer disease within six months prior to the first dose; Intestinal obstruction within 3 months prior to the first dose;
- History of bleeding, with any severe bleeding event reaching CTCAE 5.0 Grade 3 or higher within 4 weeks prior to screening;
- Patients with known central nervous system (CNS) metastases or a history of CNS metastases prior to screening. For patients clinically suspected of having CNS metastases, enhanced CT or enhanced MRI must be performed within 28 days prior to randomization to rule out CNS metastases;
- Patients with hypertension that is not well controlled with single antihypertensive therapy (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); patients with a history of unstable angina; patients newly diagnosed with angina within 3 months prior to screening or who experienced a myocardial infarction event within 6 months prior to screening; Arrhythmia (including QTcF: ≥450 ms in males, ≥470 ms in females) requiring long-term use of antiarrhythmic drugs and New York Heart Association (NYHA) class ≥II heart failure;
- Urinalysis showing urine protein ≥++ and confirmed 24-hour urine protein quantification >1.0 g;
- Long-term non-healing wounds or incomplete healing of fractures;
- Imaging studies showing tumor invasion of important blood vessels or, in the investigator's judgment, a high likelihood of tumor invasion of important blood vessels during treatment, leading to life-threatening hemorrhage;
- Coagulation abnormalities with a tendency to bleed (must meet the following criteria 14 days prior to enrollment: INR within the normal range without the use of anticoagulants); Patients receiving anticoagulant therapy or vitamin K antagonists such as warfarin, heparin, or their analogues; under the condition that the INR is ≤ 1.5, low-dose warfarin (1 mg orally once daily) or low-dose aspirin (daily dose not exceeding 100 mg) may be used for prophylactic purposes;
- Patients who have experienced arterial or venous thromboembolic events within the past year, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis (excluding cases where venous thrombosis caused by venous catheterization during prior chemotherapy has been deemed resolved by the investigator), and pulmonary embolism;
- For female participants: Patients who have not undergone surgical sterilization or are not postmenopausal and refuse to use a medically approved contraceptive method during the study treatment period and for 6 months after the study treatment period; reproductive-age women with a positive serum or urine pregnancy test within 7 days prior to study enrollment, or who are currently breastfeeding. Male participants: Patients who have not undergone surgical sterilization and refuse to use a medically approved contraceptive method during the study treatment period and for 6 months after the study treatment period;
- Active autoimmune disease or a history of autoimmune disease that may recur;
- Other patients deemed ineligible for inclusion 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
Fudan University, Cancer Hospital
Shanghai, Shanghai Municipality, 200032
Mei Sanjun Cai, 15212671909, caisanjuncsj@163.com
About this study
This is a single-arm, open-label clinical trial designed to evaluate the efficacy and safety of irinotecan liposome (II), 5-FU/LV in combination with bevacizumab for the treatment of advanced colorectal cancer.
- Conditions
- Colorectal Cancer
- Being tested
- Bevacizumab,Irinotecan liposome (II),5-FU/LV
- Keywords
- colorectal cancer， irinotecan liposome (II)，5-FU/LV
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bevacizumab,Irinotecan liposome (II),5-FU/LVDrug
Bevacizumab: 5 mg/kg, intravenous infusion, Day 1; Irinotecan liposome (II): 60 mg/m² (based on free base), intravenous infusion for at least 90 minutes, Day 1; 5-FU: 400 mg/m², intravenous bolus injection, Day 1; followed by 1200 mg/(m²·day) × 2 days of continuous intravenous infusion (total dose 2400 mg/m², infused over 46-48 hours); LV: 400 mg/m², intravenous infusion over 2 hours, Day 1; Q2w, continued until an event meeting the treatment discontinuation criteria occurs or the subject withdraws from the study.
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | Bevacizumab: 5 mg/kg, intravenous infusion, Day 1; Irinotecan liposome (II): 60 mg/m² (based on free base), intravenous infusion for at least 90 minutes, Day 1 ; 5-FU: 400 mg/m², intravenous bolus injection, Day 1; followed by 1200 mg/(m²·day) × 2 days of continuous intravenous infusion (total dose 2400 mg/m², infused over 46-48 hours); LV: 400 mg/m², intravenous infusion over 2 hours, Day 1; Q2w, continued until an event meeting the treatment discontinuation criteria occurs or the subject withdraws from the study. Receives: Drug: Bevacizumab,Irinotecan liposome (II),5-FU/LV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety:The incidence of adverse events
Proportion of patients experiencing ≥3 grade adverse events (AE) (%);Proportion of patients experiencing AE leading to drug discontinuation (%);Proportion of patients experiencing diarrhea (all grades) (%);Proportion of patients experiencing neutropenia (all grades) (%)
Measured: start of treatment until 3-year follow-up
Secondary outcomes (4)
Objective response rate（ORR）
Measured: start of treatment until 1-year follow-up
Disease control rate(DCR)
Measured: start of treatment until 1-year follow-up
Progression-free survival(PFS)
Measured: start of treatment until 2-year follow-up
Overall survival (OS)
Measured: start of treatment until 3-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanjun Cai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sanjun Cai, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07123441
- Sponsor's protocol ID
- FDCRC108-CSJ
- Status last verified
- Aug 2025
- First submitted
- 1 Aug 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Efficacy and Safety of Irinotecan Liposome (II), 5-FU/LV in Combination With Bevacizumab for the Treatment of Advanced Colorectal Cancer
- ClinicalTrials.gov ID
- NCT07123441
- Acronym / sponsor ID
- FDCRC108-CSJ
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer， irinotecan liposome (II)，5-FU/LV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Sanjun CaiUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 14 Aug 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.
This is a single-arm, open-label clinical trial designed to evaluate the efficacy and safety of irinotecan liposome (II), 5-FU/LV in combination with bevacizumab for the treatment of advanced 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 |
|---|---|---|
| treatment | Experimental | Drug: Bevacizumab,Irinotecan liposome (II),5-FU/LVBevacizumab: 5 mg/kg, intravenous infusion, Day 1; Irinotecan liposome (II): 60 mg/m² (based on free base), intravenous infusion for at least 90 minutes, Day 1 ; 5-FU: 400 mg/m², intravenous bolus injection, Day 1; followed by 1200 mg/(m²·day) × 2 days of continuous intravenous infusion (total dose 2400 mg/m², infused over 46-48 hours); LV: 400 mg/m², intravenous infusion over 2 hours, Day 1; Q2w, continued until an event meeting the treatment discontinuation criteria occurs or the subject withdraws from the study. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged 18-75 years, no gender restrictions;
- Patients with pathologically confirmed, unresectable advanced colorectal cancer;
- According to the RECIST 1.1 criteria, patients must have at least one measurable target lesion;
- ECOG performance status: 0-1 points;
- Expected survival period ≥3 months;
Key exclusion criteria (18 listed)
- Patients who have had other malignant tumors within the past 5 years (excluding cured in situ carcinomas and basal cell skin carcinomas);
- Patients who have previously received irinotecan treatment;
- Known allergies to the study drug or its related components;
- Tumor tissue confirmed by immunohistochemistry to be dMMR status, or confirmed by next-generation sequencing (NGS)/polymerase chain reaction (PCR) to be MSI-H status;
- Confirmed by next-generation sequencing (NGS)/polymerase chain reaction (PCR) to have BRAF V600E mutation;
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 |
|---|---|---|
| Bevacizumab,Irinotecan liposome (II),5-FU/LVBevacizumab: 5 mg/kg, intravenous infusion, Day 1; Irinotecan liposome (II): 60 mg/m² (based on free base), intravenous infusion for at least 90 minutes, Day 1; 5-FU: 400 mg/m², intravenous bolus injection, Day 1; followed by 1200 mg/(m²·day) × 2 days of continuous intravenous infusion (total dose 2400 mg/m², infused over 46-48 hours); LV: 400 mg/m², intravenous infusion over 2 hours, Day 1; Q2w, continued until an event meeting the treatment discontinuation criteria occurs or the subject withdraws from the study. | Drug | treatment |
Primary outcome
Safety:The incidence of adverse events
Time frame: start of treatment until 3-year follow-up
Proportion of patients experiencing ≥3 grade adverse events (AE) (%);Proportion of patients experiencing AE leading to drug discontinuation (%);Proportion of patients experiencing diarrhea (all grades) (%);Proportion of patients experiencing neutropenia (all grades) (%)
4 secondary outcomes
Objective response rate（ORR）
Time frame: start of treatment until 1-year follow-up
Disease control rate(DCR)
Time frame: start of treatment until 1-year follow-up
Progression-free survival(PFS)
Time frame: start of treatment until 2-year follow-up
Overall survival (OS)
Time frame: start of treatment until 3-year follow-up
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 14 Aug 2025.
- 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 Bevacizumab,Irinotecan liposome (II),5-FU/LV in people with Colorectal Cancer, run by Sanjun Cai 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: opening soon, as of the sponsor's last update on 14 Aug 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 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 Sanjun Cai, PhD (+8613901815189, caisanjuncsj@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety:The incidence of adverse events (time frame: start of treatment until 3-year follow-up). 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 14 Aug 2025.