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New treatment option for Colorectal Cancer Metastatic
Official title Clinical Study of Irinotecan Liposome (II)-Based Combination Treatment for Irinotecan-resistant Colorectal Cancer.
ClinicalTrials.gov ID: NCT07044921
What this study is testing
What is Irinotecan Liposomes (II)+Cetuximab+Bevacizumabl?
Irinotecan Liposomes (II)+Cetuximab+Bevacizumabl is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for colorectal cancer metastatic.
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
- Phase II clinical study of irinotecan liposome (II)-based combination regimen as a treatment for irinotecan-resistant 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 and older
You may be able to join if
- Patients agree and have signed an informed consent form and are willing and able to comply with scheduled visits, study treatment plan, laboratory...
- 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...
- There is at least one unidimensionally measurable lesion according to the evaluation standard of solid tumor curative effect (RECIST 1.1);
You likely can't join if
- 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...
- Patients with clinical symptoms of ascites requiring puncture and drainage (excluding those with only a small amount of ascites on imaging and...
- The third fluid accumulation (such as a large amount of pleural effusion) cannot reach a stable state within 2 weeks before enrollment after...
See the full eligibility criteria
Who can 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.
- 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 ×...
- 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...
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, 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.