Metastatic Colorectal Cancer (CRC)Phase 2NCT07395063
A Clinical Study on the Treatment of Metastatic Colorectal Cancer at the Second-line or Beyond.
A Phase 2 study testing Irinotecan liposome combined with capecitabine, bevacizumab and camrelizumab in people with Metastatic Colorectal Cancer (CRC), run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine.
Trial summary
A single-arm, open-label clinical study of irinotecan liposome combined with capecitabine, bevacizumab and camrelizumab as second-line or above treatment for patients with metastatic colorectal cancer, aiming to evaluate the efficacy and safety of irinotecan liposome combined with capecitabine, bevacizumab and… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Colorectal Cancer (CRC)
- What is being tested?
- Irinotecan liposome combined with capecitabine, bevacizumab and camrelizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 1 Feb 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
- Patients pathologically diagnosed with colorectal cancer;
- Received systemic treatment on the first line;
- Age: 18 to 75 years old, gender not limited.
- There must be at least one measurable lesion as the target lesion (in accordance with the RECIST v1.1 standard);
- ECOG: 0-1;
- Expected survival period ≥3 months;
- Women of childbearing age must undergo a blood pregnancy test within 3 days before randomization, and the result must be negative. They must also be willing to take appropriate contraceptive measures during the trial and for 6 months after the end of treatment. For men, it should be agreed to use appropriate methods of contraception during the study period and within 3 months after the end of treatment;
- The subjects voluntarily joined this study and signed the informed consent form.
Who cannot join
- Patients with wild-type RAS and BRAF, whose primary lesion is located in the left colorectal tract, but who have not received cetuximab as the first-line treatment
- Patients with advanced colorectal cancer who have MSI-H or dMMR
- Those with a history of other malignant diseases in the last five years, except for cured skin cancer and cervical carcinoma in situ
- For patients with a history of uncontrolled epilepsy, central nervous system diseases or mental disorders, the researcher will determine that the clinical severity may prevent them from signing the informed consent form or affect their compliance with oral medication
- Clinically severe (i.e., active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) grade II or more severe congestive heart failure, or severe arrhythmia requiring drug intervention (see Appendix 12), or a history of myocardial infarction within the last 12 months
- Those who need immunosuppressive therapy for organ transplantation
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- Severe uncontrolled recurrent infections, or other severe uncontrolled concomitant diseases
- The baseline blood routine and biochemical indicators of the subjects did not meet the following criteria: hemoglobin ≥90g/L; The absolute neutrophil count (ANC) is ≥1.5×109/L; Platelet count ≥100×109/L; ALT and AST≤2.5 times the normal upper limit value; ALP≤2.5 times the normal upper limit value; Serum total bilirubin <1.5 times the normal upper limit value; Serum creatinine <1 times the upper limit of normal; Serum albumin ≥30g/L
- Those known to have a deficiency of dihydropyrimidine dehydrogenase (DPD)
- Those who are allergic to any investigational drug ingredients (such as irinotecan, irinotecan liposome, capecitabine, bevacizumab and camrelizumab)
- Pregnant or breastfeeding women
- Have received any of the following treatments:
- The concomitant medication contained CYP3A4, CYP2C8 strong suppressor/strong inducer or UGT1A1 strong suppressor within 2 weeks prior to randomization;Use immunosuppressants or systemic hormones for immunosuppressive purposes within 2 weeks before randomization (dose >10mg/ day, prednisone or other equivalent therapeutic hormones); <s:1> Received radiotherapy within 2 weeks prior to randomization;Undergo major surgeries (such as thoracotomy, laparotomy, etc.) within 4 weeks before randomization;The patient has received any other clinical study drug treatment within 4 weeks prior to randomization, unless it is an observational (non-interventional) clinical study or follow-up of an interventional clinical study.
- Abnormal coagulation function, with a bleeding tendency, or currently undergoing thrombolytic or anticoagulant therapy. Prophylactic use of low-dose aspirin (≤100mg/ day) and low-molecular-weight heparin (enoxaparin 40mg/ day and other low-molecular-weight heparin at equivalent doses) is permitted.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Single-arm, Open-label Clinical Study of Irinotecan Liposome Combined With Capecitabine, Bevacizumab and Camrelizumab as Second-line or Higher Treatment for Patients With Metastatic Colorectal Cancer
A single-arm, open-label clinical study of irinotecan liposome combined with capecitabine, bevacizumab and camrelizumab as second-line or above treatment for patients with metastatic colorectal cancer, aiming to evaluate the efficacy and safety of irinotecan liposome combined with capecitabine, bevacizumab and camrelizumab as second-line or above treatment for patients with metastatic colorectal cancer The medication regimen is irinotecan liposome (II) + capecitabine + bevacizumab + camrelizumab until disease progression or intolerable toxicity.
- Conditions
- Metastatic Colorectal Cancer (CRC)
- Being tested
- Irinotecan liposome combined with capecitabine, bevacizumab and camrelizumab
- Keywords
- Metastatic colorectal cancer of stage ll or higher, The treatment regimen of irinotecan liposome combined with capecitabine and camrelizumab
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irinotecan liposome combined with capecitabine, bevacizumab and camrelizumabDrug
Zeirinotecan liposome: 60mg/m2, intravenous drip, completed within 90 minutes (±5 minutes). On the first day, administer once every 3 weeks.
Capecitabine: 800mg/m ² orally, twice daily from day 1 to day 14, repeated every 3 weeks.
Bevacizumab: 7.5mg/kg, intravenous infusion, day 1, once every 3 weeks; Camrelizumab: 200mg, intravenous infusion, on the first day, once every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Irinotecan liposome combined with capecitabine, bevacizumab and camrelizumab | Experimental | Zeirinotecan liposome: 60mg/m2, intravenous drip, completed within 90 minutes (±5 minutes). On the first day, administer once every 3 weeks.
Capecitabine: 800mg/m ² orally, twice daily from day 1 to day 14, repeated every 3 weeks.
Bevacizumab: 7.5mg/kg, intravenous infusion, day 1, once every 3 weeks; Camrelizumab: 200mg, intravenous infusion, on the first day, once every 3 weeks Receives: Drug: Irinotecan liposome combined with capecitabine, bevacizumab and camrelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS）
Progression-free survival (PFS) is a measure used in clinical trials and medical research to evaluate the effectiveness of treatments, especially in oncology. It refers to the length of time during and after treatment that a patient lives with a disease without it getting worse. In other words, PFS is the duration from the start of treatment until the disease progresses or until the patient dies from any cause.
Measured: through study completion,about 3 years
Secondary outcomes (4)
Objective response rate (ORR)
The objective response rate (ORR) is a key endpoint used in clinical trials, particularly in oncology, to assess the effectiveness of a treatment in shrinking or eliminating tumors. It is defined as the proportion of patients in a study who achieve a partial response (PR) or a complete response (CR) to the treatment.
Measured: through study completion,about 3 years
Duration of remission (DoR）
Duration of remission (DoR) is a critical metric in clinical oncology and hematology, particularly when evaluating the effectiveness of treatments for cancers or other diseases that can enter a state of remission. It refers to the length of time during which a patient's disease remains in remission following treatment.
Measured: through study completion,about 3 years
Disease Control Rate (DCR）
the proportion of patients whose disease is controlled by the treatment. It includes patients who achieve a complete response (CR), partial response (PR), or stable disease (SD) after treatment.
Measured: through study completion,about 3 years
Overall survival
OS is defined as the duration from the start of treatment or diagnosis until death from any cause. It represents the ultimate measure of a treatment's impact on patient longevity.
Measured: through study completion,about 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start1 Feb 2026 (estimated)
- Primary completion1 Feb 2029 (estimated)
- Study completion1 Feb 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 The Fourth Affiliated Hospital of Zhejiang University School of MedicineThe 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
- 68 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- DEZHI LI, Principal investigator, 4th Affiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07395063
- Sponsor's protocol ID
- KY-2025-254
- Status last verified
- Feb 2026
- First submitted
- 9 Jan 2026
- Last updated
- 9 Feb 2026
- 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 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open-label Clinical Study of Irinotecan Liposome Combined With Capecitabine, Bevacizumab and Camrelizumab as Second-line or Higher Treatment for Patients With Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT07395063
- Acronym / sponsor ID
- KY-2025-254
- Conditions
- Metastatic Colorectal Cancer (CRC)
- Keywords
- Metastatic colorectal cancer of stage ll or higher, The treatment regimen of irinotecan liposome combined with capecitabine and camrelizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Feb 2029 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 9 Feb 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.
A single-arm, open-label clinical study of irinotecan liposome combined with capecitabine, bevacizumab and camrelizumab as second-line or above treatment for patients with metastatic colorectal cancer, aiming to evaluate the efficacy and safety of irinotecan liposome combined with capecitabine, bevacizumab and camrelizumab as second-line or above treatment for patients with metastatic colorectal cancer The medication regimen is irinotecan liposome (II) + capecitabine + bevacizumab + camrelizumab until disease progression or intolerable toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Irinotecan liposome combined with capecitabine, bevacizumab and camrelizumab | Experimental | Drug: Irinotecan liposome combined with capecitabine, bevacizumab and camrelizumabZeirinotecan liposome: 60mg/m2, intravenous drip, completed within 90 minutes (±5 minutes). On the first day, administer once every 3 weeks. Capecitabine: 800mg/m ² orally, twice daily from day 1 to day 14, repeated every 3 weeks. Bevacizumab: 7.5mg/kg, intravenous infusion, day 1, once every 3 weeks; Camrelizumab: 200mg, intravenous infusion, on the first day, once every 3 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients pathologically diagnosed with colorectal cancer;
- Received systemic treatment on the first line;
- Age: 18 to 75 years old, gender not limited.
- There must be at least one measurable lesion as the target lesion (in accordance with the RECIST v1.1 standard);
- ECOG: 0-1;
Key exclusion criteria (14 listed)
- Patients with wild-type RAS and BRAF, whose primary lesion is located in the left colorectal tract, but who have not received cetuximab as the first-line treatment
- Patients with advanced colorectal cancer who have MSI-H or dMMR
- Those with a history of other malignant diseases in the last five years, except for cured skin cancer and cervical carcinoma in situ
- For patients with a history of uncontrolled epilepsy, central nervous system diseases or mental disorders, the researcher will determine that the clinical severity may prevent them from signing the informed consent form or affect their compliance with oral medication
- Clinically severe (i.e., active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) grade II or more severe congestive heart failure, or severe arrhythmia requiring drug intervention (see Appendix 12), or a history of myocardial infarction within the last 12 months
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 |
|---|---|---|
| Irinotecan liposome combined with capecitabine, bevacizumab and camrelizumabZeirinotecan liposome: 60mg/m2, intravenous drip, completed within 90 minutes (±5 minutes). On the first day, administer once every 3 weeks. Capecitabine: 800mg/m ² orally, twice daily from day 1 to day 14, repeated every 3 weeks. Bevacizumab: 7.5mg/kg, intravenous infusion, day 1, once every 3 weeks; Camrelizumab: 200mg, intravenous infusion, on the first day, once every 3 weeks | Drug | Irinotecan liposome combined with capecitabine, bevacizumab and camrelizumab |
Primary outcome
Progression-free survival (PFS）
Time frame: through study completion,about 3 years
Progression-free survival (PFS) is a measure used in clinical trials and medical research to evaluate the effectiveness of treatments, especially in oncology. It refers to the length of time during and after treatment that a patient lives with a disease without it getting worse. In other words, PFS is the duration from the start of treatment until the disease progresses or until the patient dies from any cause.
4 secondary outcomes
Objective response rate (ORR)
Time frame: through study completion,about 3 years
Duration of remission (DoR）
Time frame: through study completion,about 3 years
Disease Control Rate (DCR）
Time frame: through study completion,about 3 years
Overall survival
Time frame: through study completion,about 3 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 9 Feb 2026.
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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.
DEZHI LI principal investigator
4th Affiliated Hospital, School of Medicine, Zhejiang University, China
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Irinotecan liposome combined with capecitabine, bevacizumab and camrelizumab in people with Metastatic Colorectal Cancer (CRC), run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine.
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 14 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 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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 DEZHI LI (152 6868 5138, mdlidezhi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS） (time frame: through study completion,about 3 years). 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 9 Feb 2026.