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New treatment option for Metastatic Colorectal Cancer
Official title New Second-Line Combo Therapy for MSS Metastatic Colorectal Cancer
ClinicalTrials.gov ID: NCT07559760
What this study is testing
What is Levofolinic Acid + 5-FU continuous infusion + irinotecan HCl liposome ± cetuximab/bevacizumab?
Levofolinic Acid + 5-FU continuous infusion + irinotecan HCl liposome ± cetuximab/bevacizumab is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for metastatic colorectal cancer.
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
- 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.
- 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
- 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 ±...
- Failure definition: progression during or within 3 months after completing first-line oxaliplatin/fluoropyrimidine ± targeted therapy.
- Adjuvant setting: progression/recurrence during or within 6 months of completing adjuvant oxaliplatin-based chemotherapy/chemoradiation counts as...
You likely can't join if
- 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...
- Any anti-cancer therapy (chemotherapy, radiotherapy, biologics, targeted therapy, immunotherapy, etc.) within 4 weeks before first study-dose; major...
- Severe psychiatric or psychological disorders that could compromise compliance.
See the full eligibility criteria
- 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.
- Adjuvant setting: progression/recurrence during or within 6 months of completing adjuvant oxaliplatin-based chemotherapy/chemoradiation counts as first-line failure.
- At least one measurable lesion by RECIST 1.1.
- ECOG performance status 0-1.
- Expected survival ≥ 3 months.
- Adequate organ function within 14 days before enrollment (no transfusion or growth-factor support):
- Hematology: Hb ≥ 90 g/L; WBC ≥ 3.0 × 10⁹/L; ANC ≥ 1.5 × 10⁹/L; PLT ≥ 90 × 10⁹/L.
- Coagulation: INR ≤ 1.5 × ULN; APTT ≤ 1.5 × ULN (stable anticoagulation at therapeutic range allowed).
- Renal: Creatinine clearance ≥ 50 mL/min (Cockcroft-Gault).
- Hepatic:
- No liver mets: TBIL ≤ 1.5 × ULN, ALT ≤ 2.5 × ULN, AST ≤ 2.5 × ULN.
- Liver mets: TBIL ≤ 2 × ULN, ALT ≤ 5 × ULN, AST ≤ 5 × ULN.
- Cardiac: LVEF ≥ 50 %.
- Voluntary written informed consent; willing and able to comply with study procedures and follow-up.
- WOCBP must have a negative serum/urine pregnancy test within 3 days before first study-dose (Cycle 1 Day 1).
- All people (men and women) with reproductive potential must use a highly effective contraceptive method (annual failure rate \< 1 %) from screening until 120 days after the last dose of investigational product or 180...
- 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).
- Any anti-cancer therapy (chemotherapy, radiotherapy, biologics, targeted therapy, immunotherapy, etc.) within 4 weeks before first study-dose; major surgery (excluding biopsy) within 4 weeks that has not fully healed.
- Severe psychiatric or psychological disorders that could compromise compliance.
- Clinically significant cardiovascular disease:
- Severe/unstable angina, symptomatic congestive heart failure (NYHA ≥ II), clinically significant arrhythmia requiring treatment, arterial thrombosis, acute coronary syndrome, MI, cerebrovascular accident (including TIA)...
- QTcF ≥ 450 ms (men) or ≥ 470 ms (women) on resting 12-lead ECG.
- Infection-related:
- Active infection or unexplained fever \> 38.5 °C on screening or dosing day (tumor fever allowed at investigator's discretion).
- Serious infection (CTCAE Grade 3, e.g., pneumonia, bacteremia) requiring hospitalization within 4 weeks.
- Active pulmonary inflammation on baseline imaging or need for systemic antibiotics (prophylactic antibiotics permitted).
- Known HIV-positive, active hepatitis B, or hepatitis C:
- HBsAg or HBcAb positive: HBV DNA must be ≤ 2.5 × 10³ copies/mL (or ≤ 500 IU/mL, or below LLoQ); HBsAg(+) people must receive anti-HBV prophylaxis throughout study treatment.
- HCV-seropositive allowed only if HCV RNA negative (or below LLoQ).
- History or current evidence of leptomeningeal metastases. Active brain metastases: untreated and/or symptomatic, or requiring corticosteroids or anticonvulsants. people treated with surgery or radiotherapy may enter if...
- Other severe uncontrolled disorders (e.g., frequent seizures, hepatic failure).
- Other malignancies within 5 years, except adequately treated basal-cell carcinoma of skin or cervical carcinoma in situ.
- Participation in another clinical drug trial within 4 weeks or less than 5 half-lives of the previous investigational agent, whichever is longer.
- Any social or medical condition that, in the investigator's opinion, could interfere with informed consent, study participation, or interpretation of results.
- Patients deemed by the investigator to be unsuitable for enrollment.
The study team makes the final eligibility decision.
Where it's taking place
- Changchun, Jilin, 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 Changchun, Jilin, 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.