Colorectal CancerPhase 4NCT06269445
The Efficacy and Safety of Lcaritin Combined With Bevacizumab and FOLFIRI in Treatment of Liver Metastases From Colorectal Cancer
A Phase 4 study testing Icaritin Combined With Bevacizumab and FOLFIRI in people with Colorectal Cancer, run by Sir Run Run Shaw Hospital at 1 site in China.
Trial summary
To evaluate the efficacy and safety of the combination regimen of Icaritin with bevacizumab + FOLFIRI in patients with liver metastases from advanced colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Icaritin Combined With Bevacizumab and FOLFIRI
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 1 Feb 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- 1). Age ≥ 18 years. 2).Patients with unresectable advanced metastatic colorectal cancer confirmed by clinical diagnostic criteria and/or histopathological or cytological examination. Metastases include, but are not limited to the liver.
- 3). Presence of clearly measurable (RECIST 1.1 compliant) liver metastases on imaging assessment (unresectable by MDT assessment).
- 4). Patients who have failed prior first-line systemic systemic therapy, including bevacizumab.
- 5).ECOG PS score 0-1. 6). Have normal organ function and meet the following criteria on laboratory tests within 7 days prior to initiation of therapy:
- Haemoglobin level > 80 g/L;
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L;
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- Platelet count ≥50×10-9/L;
- Serum albumin ≥ 30 g/L;
- Total bilirubin ≤ 2 × upper limit of normal (ULN);
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 5 × ULN;
- Alkaline phosphatase (ALP) ≤ 2.5 x ULN;
- creatinine ≤ 1.5 x ULN and creatinine clearance ≥ 50 ml/min. 7). Good swallowing function. 8). Coagulation function: international normalised ratio (INR) ≤ 1.5 x ULN or prothrombin time (PT)≤16s.
- 9). Life expectancy ˃3 months. 10). Voluntary participation in this study and voluntary signing of informed consent.
- 11). Men and women of gestational age must agree to use adequate contraception throughout the study and for 3 months after the end of treatment.
Who cannot join
- 1). Pre-existing or coexisting other active malignant tumours (except for malignant tumours that have been curatively treated and have been free of malignancy that has received curative treatment and has been free of morbidity for more than 5 years or carcinoma in situ that can be cured by adequate treatment).
- 2). Concomitant administration of modern Chinese medicinal preparations for antitumour and anti-tumour indications.
- 3). Patients who have received chemotherapy or anti-vascular endothelial growth factor receptor (VEGF) therapy.
- 4). Patients receiving systemic chemotherapy, hormonal therapy, immunotherapy, approved proteins/antibodies or any experimental drugs or treatments (30 days) or radiotherapy (within 14 days).
- 5). Tumour invasion of large blood vessels. 6). Significant cardiovascular compromise within 12 months prior to the first dose of study drug: e.g., New York Heart Association (NYHA) Class II or higher. Stroke, myocardial infarction or cerebral haemorrhage, or arrhythmia associated with haemodynamic instability; Corrected QT (QTc) interval prolongation >480ms.
- 7). Any surgical procedure within the last 28 days. 8). Bleeding from ruptured oesophageal or gastric varices within the last 2 weeks, or unconfirmed severe varices and bleeding in the judgement of the investigator.
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- 9). Bleeding or thrombotic disorders or on thrombolytic therapy, coagulation disorders; study intervention Clinically significant haemoptysis or tumour bleeding of any cause within 2 weeks prior to first dose.
- 10). Patients with uncontrolled epilepsy, history of central nervous system disease or psychiatric disorders, hypertension.
- 11). Active autoimmune disease requiring systemic therapy within the past 2 years.
- 12). Clinically significant ascites on physical examination that cannot be controlled medically.
- 13). Pregnant or breastfeeding female patients, or those unwilling to use contraception during the trial.
- 14). Known hypersensitivity to Icaritin, Bevacizumab and chemotherapeutic drug components.
- 15). Suspect that it may cause contraindication to the use of the drug, or affect the reliability of the study results, or place the patient at a disease or condition that places the patient at high risk for treatment complications, or affects the patient's adherence to the trial medication.
- 16). Vulnerable populations, including those with mental illness, cognitive impairment, critically ill patients, illiteracy, etc.
- 17). Presence of other reasons that the investigator considers inappropriate for participation in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Fei Wang, 13732236150, 21418531@zju.edu.cn
About this study
Official title: The Efficacy and Safety of Lcaritin Combined With Bevacizumab and FOLFIRI in Treatment of Liver Metastases From Colorectal Cancer: A Prospective, Single-arm Study
To evaluate the efficacy and safety of the combination regimen of Icaritin with bevacizumab + FOLFIRI in patients with liver metastases from advanced colorectal cancer.
Read the detailed description
At present, second-line only targeting combined with chemotherapy is the main treatment option, and the choice of treatment modality is limited, with the immunotherapy rise of immunotherapy, the mode of combining immunotherapy on the basis of existing first- and second-line chemotherapy combined with targeting is also being actively explored, but no positive results of large-scale phase III clinical studies have been reported yet. Meanwhile, there is no solution to the the problem of pro-inflammatory factor release. Therefore, it is necessary to consider the combination of a drug with a better safety profile and target-immunity synergistic effect. A combination of drugs with better safety and target-immunity synergistic effect could be considered as a safer and more effective treatment option for patients with liver metastases from advanced colorectal cancer.
- Conditions
- Colorectal Cancer
- Being tested
- Icaritin Combined With Bevacizumab and FOLFIRI
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Icaritin Combined With Bevacizumab and FOLFIRIDrug
Bevacizumab and FOLFIRI are second-line treatment options for colorectal cancer; synergistic efficacy expected in combination with Icaritin
| Study group | Role | What they receive |
|---|---|---|
| Icaritin Combined With Bevacizumab and FOLFIRI | Experimental | Icaritin: 600 mg orally, bid; Bevacizumab: Intravenous infusion, 5 mg/kg per dose, every 14 days; FOLFIRI: ①Irinotecan: Irinotecan should be given on the first day of chemotherapy at a dose of 180mg/m2 by intravenous drip.The infusion time should be >30-90min.
②Calcium folinate: give irinotecan at a dose of 400mg/m2 by intravenous drip in conjunction with irinotecan infusion, and the infusion time should be up to 2h.
③5-fluorouracil: give intravenous infusion at a dose of 400mg/m2 on the first day of chemotherapy, then give an intravenous drip at a dose of 1200mg/m2 for 2 days, the total amount of 2400mg/m2 , and continue to be infused for 46-48h. Receives: Drug: Icaritin Combined With Bevacizumab and FOLFIRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival(PFS)
Time between the start of the trial and the onset of (any aspect of) tumour progression or death (from any cause).
Measured: up to 5 years
Secondary outcomes (6)
Objective remission rate (ORR)
The proportion of patients whose tumour volume shrinks to a pre-specified value and who are able to maintain the minimum timeframe requirement is the sum of the proportions in complete and partial remission.
Measured: up to 5 years
Overall survival (OS)
Time from start of trial to death (from any cause).
Measured: up to 5 years
Disease Control Rate (DCR)
Number of cases in remission (PR+CR) and stable lesions (SD) after treatment as a percentage of evaluable cases.
Measured: up to 5 years
Duration of ongoing remission (DOR)
The time from the start of the first assessment of the tumour as CR or PR to the first assessment of PD (Progressive Disease) or death from any cause.
Measured: up to 5 years
TRAEs
Number of participants with treatment-related adverse events as assessed by NCI-CTCAE v5.0
Measured: up to 5 years
Quality of life of the patients
Quality of life of the patients will be assessed by Functional Assessment of Cancer Therapy - Colorectal (FACT-C) questionnaire liscenced from The Functional Assessment of Chronic Illness Therapy System ("FACIT System"). By using the Manual scoring template, some items are reverse scored. Subscale scores, total scores and TOI scores. The higher the score, the better the QOL.
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start1 Jan 2024
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Feb 2026 (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.
- More trials run by Sir Run Run Shaw 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheng Dai, Sir Run Run Shaw Hospital
- Investigators
- Sheng Dai, Principal investigator, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06269445
- Sponsor's protocol ID
- 2023-942-01
- Status last verified
- Feb 2024
- First submitted
- 24 Jan 2024
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data is expected to be released on Dec 2025, and will be uploaded to http://www.medresman.org.cn/ Clinical Research Data Management Platform
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Lcaritin Combined With Bevacizumab and FOLFIRI in Treatment of Liver Metastases From Colorectal Cancer: A Prospective, Single-arm Study
- ClinicalTrials.gov ID
- NCT06269445
- Acronym / sponsor ID
- 2023-942-01
- Conditions
- Colorectal Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 21 Feb 2024 (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.
To evaluate the efficacy and safety of the combination regimen of Icaritin with bevacizumab + FOLFIRI in patients with liver metastases from advanced colorectal cancer.
Detailed description
At present, second-line only targeting combined with chemotherapy is the main treatment option, and the choice of treatment modality is limited, with the immunotherapy rise of immunotherapy, the mode of combining immunotherapy on the basis of existing first- and second-line chemotherapy combined with targeting is also being actively explored, but no positive results of large-scale phase III clinical studies have been reported yet. Meanwhile, there is no solution to the the problem of pro-inflammatory factor release. Therefore, it is necessary to consider the combination of a drug with a better safety profile and target-immunity synergistic effect. A combination of drugs with better safety and target-immunity synergistic effect could be considered as a safer and more effective treatment option for patients with liver metastases from 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 |
|---|---|---|
| Icaritin Combined With Bevacizumab and FOLFIRI | Experimental | Drug: Icaritin Combined With Bevacizumab and FOLFIRIIcaritin: 600 mg orally, bid; Bevacizumab: Intravenous infusion, 5 mg/kg per dose, every 14 days; FOLFIRI: ①Irinotecan: Irinotecan should be given on the first day of chemotherapy at a dose of 180mg/m2 by intravenous drip.The infusion time should be >30-90min. ②Calcium folinate: give irinotecan at a dose of 400mg/m2 by intravenous drip in conjunction with irinotecan infusion, and the infusion time should be up to 2h. ③5-fluorouracil: give intravenous infusion at a dose of 400mg/m2 on the first day of chemotherapy, then give an intravenous drip at a dose of 1200mg/m2 for 2 days, the total amount of 2400mg/m2 , and continue to be infused for 46-48h. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 1). Age ≥ 18 years. 2).Patients with unresectable advanced metastatic colorectal cancer confirmed by clinical diagnostic criteria and/or histopathological or cytological examination. Metastases include, but are not limited to the liver.
- 3). Presence of clearly measurable (RECIST 1.1 compliant) liver metastases on imaging assessment (unresectable by MDT assessment).
- 4). Patients who have failed prior first-line systemic systemic therapy, including bevacizumab.
- 5).ECOG PS score 0-1. 6). Have normal organ function and meet the following criteria on laboratory tests within 7 days prior to initiation of therapy:
- 9). Life expectancy ˃3 months. 10). Voluntary participation in this study and voluntary signing of informed consent.
Key exclusion criteria (15 listed)
- 1). Pre-existing or coexisting other active malignant tumours (except for malignant tumours that have been curatively treated and have been free of malignancy that has received curative treatment and has been free of morbidity for more than 5 years or carcinoma in situ that can be cured by adequate treatment).
- 2). Concomitant administration of modern Chinese medicinal preparations for antitumour and anti-tumour indications.
- 3). Patients who have received chemotherapy or anti-vascular endothelial growth factor receptor (VEGF) therapy.
- 4). Patients receiving systemic chemotherapy, hormonal therapy, immunotherapy, approved proteins/antibodies or any experimental drugs or treatments (30 days) or radiotherapy (within 14 days).
- 5). Tumour invasion of large blood vessels. 6). Significant cardiovascular compromise within 12 months prior to the first dose of study drug: e.g., New York Heart Association (NYHA) Class II or higher. Stroke, myocardial infarction or cerebral haemorrhage, or arrhythmia associated with haemodynamic instability; Corrected QT (QTc) interval prolongation >480ms.
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 |
|---|---|---|
| Icaritin Combined With Bevacizumab and FOLFIRIBevacizumab and FOLFIRI are second-line treatment options for colorectal cancer; synergistic efficacy expected in combination with Icaritin | Drug | Icaritin Combined With Bevacizumab and FOLFIRI |
Primary outcome
Progression-free survival(PFS)
Time frame: up to 5 years
Time between the start of the trial and the onset of (any aspect of) tumour progression or death (from any cause).
6 secondary outcomes
Objective remission rate (ORR)
Time frame: up to 5 years
Overall survival (OS)
Time frame: up to 5 years
Disease Control Rate (DCR)
Time frame: up to 5 years
Duration of ongoing remission (DOR)
Time frame: up to 5 years
TRAEs
Time frame: up to 5 years
Quality of life of the patients
Time frame: up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Individual participant dataSharing planned: Yes. The data is expected to be released on Dec 2025, and will be uploaded to http://www.medresman.org.cn/ Clinical Research Data Management Platform
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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. This study is not recruiting at the moment.
Sheng Dai principal investigator
Sir Run Run Shaw Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Icaritin Combined With Bevacizumab and FOLFIRI in people with Colorectal Cancer, run by Sir Run Run Shaw 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 14 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 21 Feb 2024. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fei Wang (13732236150, 21418531@zju.edu.cn), 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: up to 5 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 21 Feb 2024.