Colorectal Cancer MetastaticPhase 2NCT07044921
Clinical Study of Irinotecan Liposome (II)-Based Combination Treatment for Irinotecan-resistant Colorectal Cancer.
A Phase 2 study testing Irinotecan Liposomes (II)+Cetuximab+Bevacizumabl in people with Colorectal Cancer Metastatic, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
Phase II clinical study of irinotecan liposome (II)-based combination regimen as a treatment for irinotecan-resistant colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer Metastatic
- What is being tested?
- Irinotecan Liposomes (II)+Cetuximab+Bevacizumabl
- 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 Sep 2024to 31 Jul 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients agree and have signed an informed consent form and are willing and able to comply with scheduled visits, study treatment plan, laboratory tests, and other trial procedures;
- age: 18 years and older, male or female;
- patients with pathologically confirmed advanced colorectal cancer(excluding all other histological types);
- Patients with colorectal cancer who have received ≥ second-line systemic antitumor therapy (including chemotherapy with irinotecan regimen, targeted therapy, etc.);
- There is at least one unidimensionally measurable lesion according to the evaluation standard of solid tumor curative effect (RECIST 1.1);
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
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- expected survival ≥ 3 months;
- Normal function of major organs. Laboratory tests were to meet the following requirements: hemoglobin (Hb) ≥ 9 g/dL (90 g/L) (no corrective treatment used within 14 days); neutrophil count (ANC) ≥ 1,500/mm3 (1.5 × 109/L) (no growth factors used within 14 days); white blood cell count (WBC) ≥ 3.0 × 109/L(no corrective treatment used within 14 days);platelet count (PLT) ≥ 100,000/mm3 (100 × 109/L) (no corrective treatment used within 14 days) ; total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels ≤ 3 times the upper limit of normal (ULN), and ≤ 5 × ULN for patients with liver metastases; Serum Cr ≤ 1.5 times ULN, endogenous creatinine clearance > 50ml/min (Cockcroft-Gault formula);Doppler ultrasound evaluation: Left ventricular ejection fraction (LVEF) ≥ lower limit of normal (50%); international normalized ratio INR ≤ 1.5 × ULN and activated partial thromboplastin time ≤ 1.5 × ULN;
- Patients with potential fertility need to use a medically recognized contraceptive (such as intrauterine device, contraceptives or condoms) during study treatment and within 6 months after the end of study treatment; and must have a negative serum HCG test within 7 days before study enrollment; and must be non-lactating. Male participants in this study consent to the utilisation of contraceptive measures for the duration of the study period, in addition to a six-month period subsequent to the study's conclusion.
Who cannot join
- Previously or simultaneously suffering from other malignant tumors, except for cured skin basal cell carcinoma and cervical carcinoma in situ;
- Participated in clinical trials of other drugs within the four weeks prior to enrollment;
- Severe gastrointestinal dysfunction (bleeding, obstruction; inflammation greater than grade 2; diarrhea greater than grade 1);
- Patients with gastrointestinal perforation, gastrointestinal fistula, intra-abdominal abscess, and non gastrointestinal fistula (such as tracheoesophageal fistula) within the first 6 months of enrollment；
- Patients with clinical symptoms of ascites requiring puncture and drainage (excluding those with only a small amount of ascites on imaging and controllable, but without clinical symptoms);
- The third fluid accumulation (such as a large amount of pleural effusion) cannot reach a stable state within 2 weeks before enrollment after treatment (no intervention treatment is required after removing the drainage tube);
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- Patients with a clear tendency towards gastrointestinal bleeding, including the following conditions: local active ulcer lesions and fecal occult blood [(++) not eligible for inclusion]; Individuals with a history of black stool and vomiting blood within 2 months;
- Known interstitial lung disease, except for interstitial changes shown only by imaging;
- Patients known to have central nervous system metastases or a history of central nervous system metastases prior to screening. For patients suspected of having central nervous system metastasis in clinical practice, enhanced CT or enhanced magnetic resonance imaging (MRI) examination must be performed within 28 days before enrollment to rule out central nervous system metastasis;
- Within 2 weeks prior to enrollment, concomitant medications containing strong inhibitors/inducers of CYP3A4, CYP2C8, or UGT1A1;
- Individuals with hypertension who cannot achieve good control with single antihypertensive medication (systolic blood pressure>140 mmHg, diastolic blood pressure>90 mmHg); Individuals with a history of unstable angina pectoris; Newly diagnosed with angina pectoris within the first 3 months of screening or experiencing myocardial infarction events within the first 6 months of screening; Cardiac arrhythmia (including QTcF: male ≥ 450 ms, female ≥ 470 ms) requires long-term use of antiarrhythmic drugs and New York Heart Association classification of ≥ II heart failure;
- Individuals who are known to be allergic to any of the ingredients in Irinotecan Liposomes (II), other liposome products, Bevacizumab or Cetuximab, etc;
- Individuals with abnormal coagulation function and bleeding tendency (must meet the requirement of INR being within the normal range without using anticoagulants within 14 days before enrollment); Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or their analogues; Under the condition that the International Normalized Ratio (INR) of prothrombin time is ≤ 1.5, it is allowed to use low-dose warfarin (1 mg orally, once daily) or low-dose aspirin (daily dose not exceeding 100 mg) for preventive purposes;
- For female participants: Non surgical sterilization or non postmenopausal patients who refuse to use a medically approved contraceptive measure during the study treatment period and within 6 months after the end of the study treatment period; Women of childbearing age who tested positive for pregnancy in serum or urine within 7 days prior to enrollment in the study, or are currently breastfeeding. Male subjects: patients who have undergone non-surgical sterilization and refuse to use a medically approved contraceptive measure during the study treatment period and within 6 months after the end of the study treatment period;
- Combined with active hepatitis B (hepatitis B surface antigen positive and HBV DNA ≥ 500IU/mL), hepatitis C (hepatitis C antibody positive and HCV-RNA higher than the upper limit of normal); Known to have acquired immunodeficiency syndrome (AIDS) or HIV test positive, active syphilis infection;
- The patient has an active infection, an unexplained fever of ≥ 38.5 ℃ within one week prior to enrollment, or a white blood cell count>15 × 109/L during the screening period; therapeutic antibiotics were administered orally or intravenously within two weeks prior to enrollment (excluding prophylactic antibiotics administered intravenously for no more than 48 hours)；
- Having a clear history of neurological or mental disorders, including epilepsy or dementia;
- According to the researcher's assessment, there are accompanying diseases that pose a serious threat to patient safety or affect the completion of the study;
- Researchers assess other situations that may affect the progress of clinical research and the determination of research results.
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
Chinese PLA General Hospital, Beijing,
Beijing
Guanghai Dai, 01066947252, daigh301@vip.sina.com
About this study
Official title: A Single-center Phase II Clinical Study of Irinotecan Liposome (II)-Based Combination Regimen as a Treatment for Irinotecan-Resistant Colorectal Cancer.
Phase II clinical study of irinotecan liposome (II)-based combination regimen as a treatment for irinotecan-resistant colorectal cancer.
Read the detailed description
To observe and evaluate the efficacy and safety of irinotecan liposome (II)-based combination regimen as a treatment for irinotecan-resistant colorectal cancer.
- Conditions
- Colorectal Cancer Metastatic
- Being tested
- Irinotecan Liposomes (II)+Cetuximab+Bevacizumabl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irinotecan Liposomes (II)+Cetuximab+BevacizumablDrug
Irinotecan Liposomes (II) injection：Intravenous infusion, 60 mg/m2, Day 1, Q2W. The recommended initial dosage of irinotecan liposomes (II) for patients with the UGT1A1 * 28/* 6 homozygous mutation is 47.1 mg/m2.
Cetuximab injection：Intravenous infusion, 500 mg/m2, Day 1, Q2W. Bevacizumabl: Intravenous infusion, 5mg/kg, Day 1, Q2W.
| Study group | Role | What they receive |
|---|---|---|
| Irinotecan Liposomes (II)+Cetuximab+Bevacizumabl | Experimental | Irinotecan Liposomes (II)，Cetuximab and Bevacizumabl injection was started on Day 1 of each cycle.Combined treatment for 2 weeks, after efficacy evaluation, the investigator decides the subsequent treatment regimen, or until disease progression, toxicity intolerance, initiation of new anti-tumor therapy, withdrawal of informed consent, or the investigator judges that the subject needs to withdraw from the study treatment. Following RECISTv1.1 defined progression (as assessed by the investigator), study drug may continue if the investigator assesses that the subject is still receiving clinical benefit and tolerates study treatment. Receives: Drug: Irinotecan Liposomes (II)+Cetuximab+Bevacizumabl |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
The time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first
Measured: up to 3 years
Secondary outcomes (5)
ORR
The proportion of patients with a confirmed complete response or partial response
Measured: up to 3 years
DCR
The proportion of patients with a best overall response of confirmed complete or partial response, or stable disease
Measured: up to 3 years
OS
The time from randomization to death from any reason
Measured: up to 3 years
DoR
The length of time that a tumor continues to respond to treatment without the cancer growing or spreading.
Measured: up to 3 years
Adverse Event
The dose suspension rate and dose termination rate caused by adverse events were determined according to NCI-CTCAE V5.0 standard
Measured: Safety visits were made before medication in each treatment cycle day1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start1 Sep 2024
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by Chinese PLA General 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dai, Guanghai, Chinese PLA General Hospital
- Investigators
- Guanghai Dai, Doctor, Study chair, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07044921
- Sponsor's protocol ID
- 2024-438-02
- Status last verified
- Jun 2025
- First submitted
- 23 Jun 2025
- Last updated
- 1 Jul 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 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center Phase II Clinical Study of Irinotecan Liposome (II)-Based Combination Regimen as a Treatment for Irinotecan-Resistant Colorectal Cancer.
- ClinicalTrials.gov ID
- NCT07044921
- Acronym / sponsor ID
- 2024-438-02
- Conditions
- Colorectal Cancer Metastatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 1 Jul 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.
Phase II clinical study of irinotecan liposome (II)-based combination regimen as a treatment for irinotecan-resistant colorectal cancer.
Detailed description
To observe and evaluate the efficacy and safety of irinotecan liposome (II)-based combination regimen as a treatment for irinotecan-resistant 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 |
|---|---|---|
| Irinotecan Liposomes (II)+Cetuximab+Bevacizumabl | Experimental | Drug: Irinotecan Liposomes (II)+Cetuximab+BevacizumablIrinotecan Liposomes (II)，Cetuximab and Bevacizumabl injection was started on Day 1 of each cycle.Combined treatment for 2 weeks, after efficacy evaluation, the investigator decides the subsequent treatment regimen, or until disease progression, toxicity intolerance, initiation of new anti-tumor therapy, withdrawal of informed consent, or the investigator judges that the subject needs to withdraw from the study treatment. Following RECISTv1.1 defined progression (as assessed by the investigator), study drug may continue if the investigator assesses that the subject is still receiving clinical benefit and tolerates study treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients agree and have signed an informed consent form and are willing and able to comply with scheduled visits, study treatment plan, laboratory tests, and other trial procedures;
- age: 18 years and older, male or female;
- patients with pathologically confirmed advanced colorectal cancer(excluding all other histological types);
- Patients with colorectal cancer who have received ≥ second-line systemic antitumor therapy (including chemotherapy with irinotecan regimen, targeted therapy, etc.);
- There is at least one unidimensionally measurable lesion according to the evaluation standard of solid tumor curative effect (RECIST 1.1);
Key exclusion criteria (19 listed)
- Previously or simultaneously suffering from other malignant tumors, except for cured skin basal cell carcinoma and cervical carcinoma in situ;
- Participated in clinical trials of other drugs within the four weeks prior to enrollment;
- Severe gastrointestinal dysfunction (bleeding, obstruction; inflammation greater than grade 2; diarrhea greater than grade 1);
- Patients with gastrointestinal perforation, gastrointestinal fistula, intra-abdominal abscess, and non gastrointestinal fistula (such as tracheoesophageal fistula) within the first 6 months of enrollment；
- Patients with clinical symptoms of ascites requiring puncture and drainage (excluding those with only a small amount of ascites on imaging and controllable, but without clinical symptoms);
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 Liposomes (II)+Cetuximab+BevacizumablIrinotecan Liposomes (II) injection：Intravenous infusion, 60 mg/m2, Day 1, Q2W. The recommended initial dosage of irinotecan liposomes (II) for patients with the UGT1A1 * 28/* 6 homozygous mutation is 47.1 mg/m2. Cetuximab injection：Intravenous infusion, 500 mg/m2, Day 1, Q2W. Bevacizumabl: Intravenous infusion, 5mg/kg, Day 1, Q2W. | Drug | Irinotecan Liposomes (II)+Cetuximab+Bevacizumabl |
Primary outcome
PFS
Time frame: up to 3 years
The time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first
5 secondary outcomes
ORR
Time frame: up to 3 years
DCR
Time frame: up to 3 years
OS
Time frame: up to 3 years
DoR
Time frame: up to 3 years
Adverse Event
Time frame: Safety visits were made before medication in each treatment cycle day1
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 1 Jul 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.
Guanghai Dai, Doctor study chair
Chinese PLA General Hospital
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 Irinotecan Liposomes (II)+Cetuximab+Bevacizumabl in people with Colorectal Cancer Metastatic, run by Chinese PLA General 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 9 inclusion and 19 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 1 Jul 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 Guanghai Dai, Doctor (+861066947252, daigh301@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: up to 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 1 Jul 2025.