New Second-Line Combo Therapy for MSS Metastatic Colorectal Cancer

ConditionMetastatic Colorectal Cancer

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-75

SponsorThe First Hospital of Jilin University

About this trial

This is a single-center, single-arm study designed to evaluate the efficacy and safety of second-line treatment in patients with advanced colorectal cancer (those who have progressed on or are intolerant to first-line oxaliplatin-based regimens with or without targeted therapy) receiving Levofolinic Acid + 5-FU continuous infusion combined with irinotecan hydrochloride liposome ± cetuximab/bevacizumab. Approximately 30 patients will be enrolled.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female, aged 18-75 years.

Histologically or cytologically confirmed colorectal adenocarcinoma.

Unresectable, MSS-type metastatic colorectal cancer that has failed or is intolerant to first-line standard oxaliplatin plus fluoropyrimidine ± targeted therapy.

Failure definition: progression during or within 3 months after completing first-line oxaliplatin/fluoropyrimidine ± targeted therapy.

Disqualifiers

Prior exposure to topoisomerase-I inhibitors or their analogues in first-line therapy.

Documented hypersensitivity to any study drug or its excipients.

Pregnant or breast-feeding women.

Toxicities from prior therapy not resolved to CTCAE v5.0 Grade ≤ 1 (except alopecia or other toxicities deemed by the investigator to pose no safety risk).

Trial design

Design model

Single group

Treatments tested in this trial

Levofolinic Acid + 5-FU continuous infusion + irinotecan HCl liposome ± cetuximab/bevacizumab
Drug
Levofolinic Acid + 5-FU continuous infusion + irinotecan HCl liposome ± cetuximab/bevacizumab 1. Irinotecan HCl liposome 70 mg/m² IV over 90 min, Day 1, every 2 weeks * UGT1A1\*28 7/7 homozygotes: start at 50 mg/m²; escalate to 70 mg/m² from cycle 2 if well tolerated. * Premedication per liposomal irinotecan label. 2. Levofolinic Acid 200 mg/m² + 5-FU 2 400 mg/m², both placed in the same ambulatory pump and infused continuously over 46-48 h starting Day 1. 3. Targeted agent (physician's choice): * Bevacizumab 5 mg/kg IV, Day 1, every 2 weeks, or * Cetuximab 500 mg/m² IV, Day 1, every 2 weeks, or 400 mg/m² first dose then 250 mg/m² weekly. Liposomal irinotecan is given for a maximum of 12 cycles until progression or unacceptable toxicity. Upon investigator decision, patients may switch to maintenance: Levofolinic Acid + 5-FU continuous infusion ± bevacizumab/cetuximab.

Treatment groups

30 Participants

are divided into 1 treatment group

Group A: Experimental ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

mPFS

median Progression Free Survival.It is defined as the time from enrollment to the date of first documented tumor progression (assessed according to RECIST 1.1 criteria, regardless of whether treatment is continued) or the date of death from any cause, whichever occurs first.

Time frame

42 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The First Hospital of Jilin University

Lead sponsor

Source ClinicalTrials.gov

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