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New treatment option for Colorectal Neoplasms Malignant
Official title Evaluation of Irinotecan Liposome (II) Combined With 5-FU, LV, and Bevacizumab for mCRC
ClinicalTrials.gov ID: NCT06643793
What this study is testing
What is Irinotecan liposome (ll) + 5-FU/LV + bevacizumab?
Irinotecan liposome (ll) + 5-FU/LV + bevacizumab is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for colorectal neoplasms malignant.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To observe and evaluate the efficacy and safety of irinotecan liposome (II) combined with 5-fluorouracil(5-FU), calcium leucovorin(LV), and bevacizumab in the treatment of metastatic colorectal cancer.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Age ≥ 18 years old and ≤ 75 years old, gender is not limited;
- Diagnosis of colorectal cancer by histopathology and/or cytology, clinical Records showing inoperable advanced metastatic colon or rectal cancer (ie...
- At least 1 measurable target lesion according to RECIST v1.1 criteria (ie, non-nodal lesions with a CT scan length ≥10 mm and nodal lesions with a CT...
- Prior first- or second-line oxaliplatin-based therapy with treatment failure or intolerance\ ; Note: \ Treatment failure or intolerance is defined as...
- ECOG physical status score 0-1;
You likely can't join if
- Have had a malignant tumor other than colorectal cancer within 5 years before the screening (cured skin basal cell or squamous cell carcinoma...
- Tumor tissue is known to have a mismatch repair defect (DMMR) status confirmed by immunohistochemistry, or a microsatellite high instability (MSI-H)...
- The second generation sequencing (NGS)/polymerase chain reaction (PCR) method confirmed that it is a BRAF V600E mutation, which is unfavorable for...
- For those who are known to have central nervous system metastases, for patients with clinically suspected central nervous system metastases, enhanced...
- Previous treatment with irinotecan/irinotecan liposome-based chemotherapy;
- Use of CYP3A4, CYP2C8 and UGT1A1 strong inhibitors/strong inducers within 14 days before starting the study. 7. Participated in other drug clinical...
See the full eligibility criteria
- Age ≥ 18 years old and ≤ 75 years old, gender is not limited;
- Diagnosis of colorectal cancer by histopathology and/or cytology, clinical Records showing inoperable advanced metastatic colon or rectal cancer (ie, stage IV according to the UICC AJCC TNM staging system [8th edition...
- At least 1 measurable target lesion according to RECIST v1.1 criteria (ie, non-nodal lesions with a CT scan length ≥10 mm and nodal lesions with a CT scan short diameter ≥15 mm) ;
- Prior first- or second-line oxaliplatin-based therapy with treatment failure or intolerance\ ; Note: \ Treatment failure or intolerance is defined as (1) disease progression during treatment or disease progression...
- ECOG physical status score 0-1;
- Expected survival time ≥ 3 months;
- No major organ dysfunction, that is, the subject's organ function level and related laboratory indicators must meet the following requirements within 14 days before the first medication: (1) Blood routine (no blood...
- Other previous antineoplastic therapy should be terminated for 4 weeks or more, and the general physical condition or associated adverse effects have recovered (toxicity ≤1 grade) or reached a stable state;
- Serum pregnancy test must be negative and non-lactation period in women of childbearing age within 7 days before receiving the test Women of child-bearing age or men whose partners are women of child-bearing age must...
- Voluntarily participate and sign an informed consent form; Ability to comply with research visit plans and other program requirements.
- Have had a malignant tumor other than colorectal cancer within 5 years before the screening (cured skin basal cell or squamous cell carcinoma, cervical carcinoma in situ, and malignant tumors assessed by researchers as...
- Tumor tissue is known to have a mismatch repair defect (DMMR) status confirmed by immunohistochemistry, or a microsatellite high instability (MSI-H) status confirmed by second-generation sequencing (NGS) polymerase...
- The second generation sequencing (NGS)/polymerase chain reaction (PCR) method confirmed that it is a BRAF V600E mutation, which is unfavorable for patients with chemotherapy prognosis;
- For those who are known to have central nervous system metastases, for patients with clinically suspected central nervous system metastases, enhanced computed tomography (CT) or enhanced nuclear magnetic resonance (MRI)...
- Previous treatment with irinotecan/irinotecan liposome-based chemotherapy;
- Use of CYP3A4, CYP2C8 and UGT1A1 strong inhibitors/strong inducers within 14 days before starting the study. 7. Participated in other drug clinical trials within 4 weeks before the first dose;
- Participated in clinical trials of other drugs within 4 weeks before the first medication;
- Clinical records showed severe gastrointestinal dysfunction (including bleeding and obstruction; NCI-CTCAE v5.0 \> Grade 2 inflammation; NCI-CTCAE v5.0 \> Grade 1 diarrhea)
- Presence of severe comorbidities, active infections, or uncontrolled diabetes that interfere with the treatment of the trial drug: (1) uncontrolled severe medical disease that the investigators believe will affect the...
- Known to be allergic or intolerant to any test drug (irinotecan hydrochloride liposome injection (Ⅱ), 5-FU/LV, bevacizumab) or an excipient thereof;
- There are known contraindications to any experimental drug (irinotecan hydrochloride liposome injection (Ⅱ), 5-FU/LV, bevacizumab);
- Women who are pregnant, breastfeeding or have given birth but refuse to use contraception;
- The researcher believes that it should be excluded from this study. For example, if the researcher judges that the subject has other factors that may lead to the forced termination of this study, such as the existence...
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.