A Phase 1 interventional study of Irinotecan Liposome and Oxaliplatin in Metastatic Colorectal Cancer, sponsored by Shanghai Zhongshan Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-03-19.
Sponsored by Shanghai Zhongshan Hospital · Phase 1, Interventional, and Treatment
Dose escalation clinical trial: To explore the dose limiting toxicity (DLT) of irinotecan liposome injection combined with oxaliplatin +5-FU/LV+ bevacizumab in first-line treatment of patients with advanced metastatic colorectal cancer, and to estimate the maximum tolerated dose (MTD) of combined administration.
Expansion clinical trial: To evaluate the safety and efficacy of irinotecan liposome injection combined with oxaliplatin +5-FU/LV+ bevacizumab or cetuximab in first-line treatment of patients with advanced metastatic colorectal cancer. Exploratory analysis of ctDNA changes and genetic mutations in patients at baseline.
This is a dose escalation and expansion study to evaluate the safety and efficacy of irinotecan liposome injection in patients with first-line treatment for metastatic colorectal cancer. In the dose escalation phase, patients will be treated with a combination regimen of irinotecan liposome injection at doses of 60mg/m2, 70mg/m2, and 80mg/m2, and 9 to 18 eligible patients are expected to be enrolled. In the expansion phase, approximately 60 patients will receive combination therapy with irinotecan liposome RP2D dose and exploratory analysis of genetic mutations at baseline and ctDNA changes during treatment.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's planned enrollment of 78 is close to the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Shanghai Zhongshan Hospital is the lead sponsor of 636 studies on the registry; 283 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
In dose escalation study, patients will be treated with irinotecan liposome injection combined with oxaliplatin +5-FU/LV+ bevacizumab. In expansion study, patients will be treated with irinotecan liposome injection combined with oxaliplatin +5-FU/LV+ bevacizumab or cetuximab, depending on their baseline mutation status. Oxaliplatin is accepted up to 12 cycles.
Drug: Irinotecan Liposome · Drug: Oxaliplatin · Drug: 5-FU · Drug: LV · Drug: Bevacizumab · Drug: Cetuximab
In dose escalation study, irinotecan liposome injection will be administered by an intravenous infusion at three doses of 60 mg/m2, 70 mg/m2 and 80 mg/m2, d1, 14 days per cycle. In expansion study, irinotecan liposome injection will be administered by an intravenous infusion at the dose of RP2D, d1, 14 days per cycle. Until the disease progresses or surgery is possible.
85 mg/m2, intravenously infusion, d1, 14 days per cycle, up to 12 cycles.
2400mg/m2, intravenous infusion, d1-2, 14 days per cycle. Until the disease progresses or surgery is possible.
400mg/m2, intravenous infusion, d1, 14 days per cycle. Until the disease progresses or surgery is possible.
5mg/kg, intravenous infusion, d1, 14 days per cycle. Until the disease progresses or surgery is possible.It is used to patients in dose escalation phase and with gene mutation in extension phase.
500mg/m2, intravenous infusion, d1, 14 days per cycle. Until the disease progresses or surgery is possible.For wild-type patients in extended phase studies.
Maximum-tolerated dose
To investigate the safety.
Time frame: Up to 14 days
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
To evaluate the incidence and severity of hematological adverse events in patients.
Time frame: Start by signing the informed consent form until 4 weeks after the last dose.
Objective response rate
To investigate the preliminary antitumor efficacy of study.
Time frame: From initial medication to the date of first documented progression or end of medication, assessed up to 20 months.
Disease control rate
To investigate the preliminary antitumor efficacy of study.
Time frame: From initial medication to the date of first documented progression or end of medication , assessed up to 20 months.
Progression free survival
To investigate the preliminary antitumor efficacy of study.
Time frame: From initial medication to the date of first documented progression or date of death from any cause, whichever came first , assessed up to 22 months.
R0 resection
To assess surgical conversion rates in patients who could be surgically resected.
Time frame: From the first dose to the surgery, assessed up to 22 months.
Changes of tumor ctDNA
To investigate the preliminary antitumor effect of this study and the relationship between ctDNA changes and disease prognosis.
Time frame: From initial medication to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 20 months.
Gene polymorphism
To investigate the polymorphism of UGT1A1 and colorectal cancer genes at baseline.
Time frame: Within a month of enrollment.
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Shanghai Zhongshan Hospital