Using irinotecan liposomes with chemotherapy for advanced colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase II clinical study aims to evaluate the efficacy and safety of irinotecan liposome injections combined with a chemotherapy regimen of 5-FU, LV, and bevacizumab in patients with inoperable metastatic colorectal cancer. A total of 86 eligible patients will receive the treatment, which includes specific dosages of the drugs administered on designated days. The study will assess various outcomes, including response rates, progression-free survival, overall survival, and safety profiles of the treatment regimen.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.
* 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.

Exclusion Criteria:

* 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.
* 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.

Where it's running

• West China Hospital，Sichuan University
  Sichuan, Sichuan, Chengdu, China Recruiting

Study contacts

• Study coordinator: Meng Qiu, MD
• Email: qiumeng33@hotmail.com
• Phone: 028-85423203

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Second-line combination treatment for MSS metastatic colorectal cancer

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• Combining radioembolization with FTD-TPI and bevacizumab for advanced colorectal cancer

  This study is testing if a new combination of a targeted radiation treatment and two medications can help people with advanced colorectal cancer who haven't responded to other treatments.

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• Combination therapy for metastatic colorectal cancer with BRAF-V600E mutation

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.