Metastatic Colorectal CancerPhase 2NCT06341296
Phase II Study of Irinotecan Liposomes in First-line Treatment of Metastatic Colorectal Cancer
A Phase 2 study testing Irinotecan Liposome, 5-FU and LV in people with Metastatic Colorectal Cancer, run by West China Hospital at 1 site in China.
Trial summary
To evaluate the objective response rate, disease control rate, progression-free survival, overall survival, surgical conversion rate and safety of irinotecan liposome combined with 5-FU/LV+ bevacizumab regimen in first-line treatment of advanced metastatic colorectal cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Irinotecan Liposome, 5-FU and LV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2024to Dec 2026
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18~85 years old.
- Histopathologically confirmed patient with an inoperable metastatic colorectal adenocarcinoma.
- RAS/BRAF v600e mutant or right half colon cancer is known.
- pMMR/MSS is known.
- The unresectable stage of metastatic disease has not received any systemic antitumor therapy.
- For subjects previously receiving neoadjuvant or adjuvant therapy, the date of first discovery of disease progression must be at least 6 months removed from the date of last administration of neoadjuvant or adjuvant therapy.
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- ECOG 0~1, patients ≥75 years old need an ECOG score of 0
- The presence of at least 1 measurable lesion that can be evaluated according to the RECIST v1.1 criteria.
- Normal bone marrow and organ function: ① Neutrophils (ANC) ≥1.5×10^9/L, platelets (PLT) ≥100×10^9/L, hemoglobin (Hb) ≥80g/L, albumin (ALB) ≥30 g/L, white blood cells (WBC) ≥3.0×10^9/L, and no bleeding tendency; ② AST, ALT and alkaline phosphatase (ALP) were all ≤2.5× upper limit of normal range (ULN), and ≤5×ULN when liver metastases occurred; The total bilirubin level doesn't exceed the upper limit of the agency's normal range; Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance ≥40 ml/min (calculated according to Cockroft-Gault)
- Understand the situation of this study, patients and/or legal representatives voluntarily agree to participate in this study and sign informed consent form.
Who cannot join
- Known or suspected central nervous system metastasis.
- Received irinotecan/irinotecan liposomes/bevacizumab before enrollment.
- Had undergone surgery and other oncologic treatments within the first 4 weeks of enrollment.
- Previous treatment-related toxicity didn't return to NCI-CTCAE v5.0 I or below(except hair loss and peripheral neuropathy).
- The use of CYP3A, CYP2C8, and UGT1A1 inhibitors or inducers couldn't be discontinued or were not discontinued within 2 weeks prior to enrollment.
- Severe gastrointestinal dysfunction, gastrointestinal perforation, intraperitoneal abscess, and fistula.
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- Intestinal obstruction, signs and symptoms of intestinal obstruction, or the stent has been previously implanted and the stent has not been removed before the screening period.
- Interstitial lung disease.
- Tendency of arterial embolism and massive bleeding within 6 months before enrollment (except surgical bleeding).
- Patients with fluid accumulation that couldn't reach a stable state but small amount of ascites on imaging without clinical symptoms could be enrolled.
- Any serious or uncontrolled systemic disease, including uncontrolled high blood pressure, heart disease, active bleeding, active viral infection, etc.
- Have had other malignancies within the past 5 years or currently, except cured cervical carcinoma in situ, uterine carcinoma in situ, and non-melanoma skin cancer.
- Patients of childbearing age who refuse to take contraceptives, women who are pregnant or breastfeeding.
- The researchers didn't consider it appropriate to participate in this study.
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
West China Hospital，Sichuan University
Sichuan, Sichuan, Chengdu, 610000
Meng Qiu, MD, 028-85423203, qiumeng33@hotmail.com
About this study
Official title: Phase II Study of Irinotecan Liposomes Combined With 5-FU/LV+ Bevacizumab in First-line Treatment of Metastatic Colorectal Cancer
To evaluate the objective response rate, disease control rate, progression-free survival, overall survival, surgical conversion rate and safety of irinotecan liposome combined with 5-FU/LV+ bevacizumab regimen in first-line treatment of advanced metastatic colorectal cancer patients.
Read the detailed description
This is a Phase II clinical study to evaluate the efficacy and safety of the combination regimen of irinotecan liposome injection in the first-line treatment of metastatic colorectal cancer. Patients will receive liposomal injections of irinotecan 70mg/m^2 d1, bevacizumab 5mg/kg d1, LV 400mg/m^2 d1, 5-FU 400mg/m^2, then 2400mg/m^2, continuous intravenous infusion for 46-48h, d1-2. 86 eligible patients will be enrolled.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Irinotecan Liposome, 5-FU, LV, 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.
Irinotecan LiposomeDrug
70 mg/m^2 , d1, 14 days per cycle, 8 cycles.
5-FUDrug
5-FU 400mg/m^2, then 2400mg/m^2, continuous intravenous infusion for 46-48h, d1-2, 14 days per cycle, 8 cycles.
LVDrug
400mg/m^2, d1, 14 days per cycle, 8 cycles.
BevacizumabDrug
5mg/kg, d1, 14 days per cycle, 8 cycles.
| Study group | Role | What they receive |
|---|---|---|
| irinotecan liposome injection combined with 5-FU/LV+ bevacizumab | Experimental | Patients will be treated with irinotecan liposome injection combined with 5-FU/LV+ bevacizumab. Treatment lasted 8 cycles. Receives: Drug: Irinotecan Liposome; Drug: 5-FU; Drug: LV; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
To investigate antitumor efficacy of study.
Measured: From initial medication to the date of first documented progression or end of medication or completed 8 cycles treatment, whichever came first . Assessed up to 4 months
Secondary outcomes (6)
Disease control rate
To investigate antitumor efficacy of study.
Measured: From initial medication to the date of first documented progression or end of medication or completed 8 cycles treatment, whichever came first. Assessed up to 4 months
Progression free survival
To investigate antitumor efficacy of study.
Measured: From initial medication to the date of first documented progression or end of medication, whichever came first. Assessed up to 30 months.
Overall survival
To investigate antitumor efficacy of study.
Measured: From initial medication to the date of death from any cause. Assessed up to 30 months.
Percentage of patients undergoing surgery.
To assess surgical conversion rates in patients who could be surgically resected.
Measured: From the first dose to completed 8 cycles treatment. Assessed up to 5 months.
R0 resection
To assess surgical conversion rates in patients who could be surgically resected.
Measured: From the first dose to the surgery. Assessed up to 6 months.
Incidence of adverse events and severity of adverse events as assessed by CTCAE 5.0
To assess the incidence and severity of adverse events in combination regimens.
Measured: From the first dose to completed 8 cycles treatment. Assessed up to 5 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start30 Jun 2024
- Primary completionApr 2026 (estimated)
- Study completionDec 2026 (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 West China 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
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meng Qiu, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06341296
- Sponsor's protocol ID
- CSPC-DEY-CRC-K07
- Status last verified
- Aug 2024
- First submitted
- 26 Mar 2024
- Last updated
- 12 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Irinotecan Liposomes Combined With 5-FU/LV+ Bevacizumab in First-line Treatment of Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06341296
- Acronym / sponsor ID
- CSPC-DEY-CRC-K07
- Conditions
- Metastatic Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 30 Jun 2024 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 2 Apr 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 objective response rate, disease control rate, progression-free survival, overall survival, surgical conversion rate and safety of irinotecan liposome combined with 5-FU/LV+ bevacizumab regimen in first-line treatment of advanced metastatic colorectal cancer patients.
Detailed description
This is a Phase II clinical study to evaluate the efficacy and safety of the combination regimen of irinotecan liposome injection in the first-line treatment of metastatic colorectal cancer. Patients will receive liposomal injections of irinotecan 70mg/m^2 d1, bevacizumab 5mg/kg d1, LV 400mg/m^2 d1, 5-FU 400mg/m^2, then 2400mg/m^2, continuous intravenous infusion for 46-48h, d1-2. 86 eligible 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 |
|---|---|---|
| irinotecan liposome injection combined with 5-FU/LV+ bevacizumab | Experimental | Drug: Irinotecan Liposome, Drug: 5-FU, Drug: LV, Drug: BevacizumabPatients will be treated with irinotecan liposome injection combined with 5-FU/LV+ bevacizumab. Treatment lasted 8 cycles. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 18~85 years old.
- Histopathologically confirmed patient with an inoperable metastatic colorectal adenocarcinoma.
- RAS/BRAF v600e mutant or right half colon cancer is known.
- pMMR/MSS is known.
- The unresectable stage of metastatic disease has not received any systemic antitumor therapy.
Key exclusion criteria (14 listed)
- Known or suspected central nervous system metastasis.
- Received irinotecan/irinotecan liposomes/bevacizumab before enrollment.
- Had undergone surgery and other oncologic treatments within the first 4 weeks of enrollment.
- Previous treatment-related toxicity didn't return to NCI-CTCAE v5.0 I or below(except hair loss and peripheral neuropathy).
- The use of CYP3A, CYP2C8, and UGT1A1 inhibitors or inducers couldn't be discontinued or were not discontinued within 2 weeks prior to enrollment.
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 Liposome70 mg/m^2 , d1, 14 days per cycle, 8 cycles. | Drug | irinotecan liposome injection combined with 5-FU/LV+ bevacizumab |
| 5-FU5-FU 400mg/m^2, then 2400mg/m^2, continuous intravenous infusion for 46-48h, d1-2, 14 days per cycle, 8 cycles. | Drug | irinotecan liposome injection combined with 5-FU/LV+ bevacizumab |
| LV400mg/m^2, d1, 14 days per cycle, 8 cycles. | Drug | irinotecan liposome injection combined with 5-FU/LV+ bevacizumab |
| Bevacizumab5mg/kg, d1, 14 days per cycle, 8 cycles. | Drug | irinotecan liposome injection combined with 5-FU/LV+ bevacizumab |
Primary outcome
Objective response rate
Time frame: From initial medication to the date of first documented progression or end of medication or completed 8 cycles treatment, whichever came first . Assessed up to 4 months
To investigate antitumor efficacy of study.
6 secondary outcomes
Disease control rate
Time frame: From initial medication to the date of first documented progression or end of medication or completed 8 cycles treatment, whichever came first. Assessed up to 4 months
Progression free survival
Time frame: From initial medication to the date of first documented progression or end of medication, whichever came first. Assessed up to 30 months.
Overall survival
Time frame: From initial medication to the date of death from any cause. Assessed up to 30 months.
Percentage of patients undergoing surgery.
Time frame: From the first dose to completed 8 cycles treatment. Assessed up to 5 months.
R0 resection
Time frame: From the first dose to the surgery. Assessed up to 6 months.
Incidence of adverse events and severity of adverse events as assessed by CTCAE 5.0
Time frame: From the first dose to completed 8 cycles treatment. Assessed up to 5 months.
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 12 Aug 2024.
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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 Irinotecan Liposome, 5-FU and LV in people with Metastatic Colorectal Cancer, run by West China 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 10 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: looking for participants now, as of the sponsor's last update on 12 Aug 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 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 Meng Qiu, MD (028-85423203, qiumeng33@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: From initial medication to the date of first documented progression or end of medication or completed 8 cycles treatment, whichever came first . Assessed up to 4 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 12 Aug 2024.