Clinical trial · Interventional
Trial of FOLF(HA)Iri With Cetuximab in mCRC
Phase II Single Arm Trial of FOLF(HA)Iri Plus Cetuximab in Irinotecan-naïve Second Line Patients With KRAS Wild Type Metastatic Colorectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
As an approach to improve efficacy and provide clinical benefit to cancer patients undergoing chemotherapeutic treatment regimens, Alchemia Oncology has developed a novel means for delivering anti-cancer agents to tumours. The drug delivery platform is based on the use of hyaluronic acid (HA), a novel excipient, in which, formulation with HA results in optimisation of cytotoxic drug uptake and retention within solid tumours. In the specific example of HA-Irinotecan, this new formulation of irinotecan has demonstrated enhanced efficacy in both nonclinical and early clinical studies. The current study is an investigation into the use of HA-Irinotecan in a Phase II single arm trial of FOLF(HA)iri plus cetuximab in irinotecan-naïve second line patients with KRAS wild type metastatic colorectal cancer. The study objectives are to confirm the safety and efficacy of FOLF(HA)iri plus cetuximab as second-line therapy in irinotecan-naïve metastatic colorectal cancer patients. It is expected that the study recruit approximately 40-50 patients in 1 year with subsequent treatment and follow up; thus the trial will run for approximately 2-3 years.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HA-Irinotecan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HA-Irinotecan
- description
- HA-Irinotecan is administered as part of FOLFIRI/cetuximab treatment in place of irinotecan.
- interventionNames
- Drug: HA-Irinotecan
Primary outcomes (1)
- measure
- Safety
- timeFrame
- 2 years
- description
- To assess FOLF(HA)iri plus cetuximab with respect to: Patient safety, including incidence of severe (Grade 3/4) toxicity according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.03).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria * Tumour is KRAS wild type * mCRC with disease progression after first-line chemotherapy (adjuvant chemotherapy is considered first line chemotherapy if metastatic progression occurs within 6 months of the end of the adjuvant chemotherapy). * Irinotecan naïve * Prior use of bevacizumab in the 1st line setting is permitted. * ECOG 0 or 1 * Measurable disease * Histological proof of colorectal adenocarcinoma * 18+ years of age * Adequately recovered from and at least 4 weeks after recent major surgery or chemotherapy * At least 4 weeks after treatment with a biologic monotherapy from last dose to enrolment. * Hematology done within 14 days prior to enrolment : * Absolute Neutrophil count (ANC) greater than 1.5 x 109/L * Platelets greater than 100 x 109/L * Hemoglobin greater than or equal to 100g/L * Chemistry done within 14 days prior to enrolment: * AST greater than or equal to 2.5 X ULN (greater than 5 X ULN if elevation thought to be related to hepatic metastatic disease), * Alkaline phosphatase greater than 5 x ULN, * Serum creatinine greater than 1.5 x ULN, * Total bilirubin greater than 34.2 µmol/L, * Negative serum or urine pregnancy test if a WOCBP. Exclusion criteria * KRAS mutant. * Prior irinotecan * Prior anti-EGFR * History of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for greater than 5 years. * Locally advanced or recurrent disease only * Unsuitability for irinotecan * Abdominal or pelvic radiation therapy (including treatment with SIR-Spheres/Sirtex) within the last 12 months. * Women who are pregnant or breastfeeding. * Significant cardiac disease * Untreated or symptomatic brain or central nervous system (CNS) metastases * Presence of pleural effusion or ascites requiring therapeutic thoracocentesis or paracentesis. * Current partial or complete bowel obstruction. * Concomitant active infection.
References
Publications (0)
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