BridgeMD
New treatment option for Metastatic Colorectal Cancer
Official title Cetuximab Plus Irinotecan in Patients With NeoRAS Wild-type Metastatic Colorectal Cancer In Third-line Therapy
ClinicalTrials.gov ID: NCT05962502
What this study is testing
What is Cetuximab and irinotecan?
Cetuximab and irinotecan is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for metastatic colorectal cancer.
Also referred to as ERBITUX.
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-arm, open-label, phase II clinical trial. The goal of this study is to evaluate the efficacy and safety of cetuximab plus irinotecan in patients with NeoRAS wild-type primary left-sided mCRC in third-line therapy.
- 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 and older
You may be able to join if
- Age ≥ 18 years.
- Histologically confirmed colorectal adenocarcinoma.
- Patients with initial RAS mutant, BRAF wild-type left-sided mCRC.
- Progression after standard first-line and second-line therapy (previously treated with fluorouracil compounds, oxaliplatin and irinotecan).
- Tumor progression within 3 months during or after irinotecan-containing regimen.
You likely can't join if
- Primary right-sided mCRC.
- dMMR/MSI-H mCRC.
- Patients with initial RAS wild-type or BRAF mutant mCRC.
- ctDNA testing shows that RAS or BRAF gene is mutant mCRC after second-line therapy.
- Serious arterial embolism or ascites.
- Serious bleeding tendency or coagulation disorder.
See the full eligibility criteria
- Age ≥ 18 years.
- Histologically confirmed colorectal adenocarcinoma.
- Patients with initial RAS mutant, BRAF wild-type left-sided mCRC.
- Progression after standard first-line and second-line therapy (previously treated with fluorouracil compounds, oxaliplatin and irinotecan).
- Tumor progression within 3 months during or after irinotecan-containing regimen.
- Blood-based ctDNA testing shows that both RAS and BRAF genes are wild-type after second-line therapy progression .
- There are objectively measurable lesions according to RECIST v1.1 criteria.
- Normal hematologic function (platelets \> 90 × 109/L; leukocytes \> 3 × 109/L; neutrophils \> 1.5 × 109/L; hemoglobin \> 8.0g/100ml).
- Serum bilirubin ≤ 1.5 x the upper limit of normal (ULN) and transaminases ≤ 5 x ULN.
- Normal coagulation function, albumin ≥ 35 g/L.
- Liver function: Child-Push score: Class A.
- Serum creatinine \< 1.5 x ULN, or calculated creatinine clearance ≥ 50 ml/min (using the Cockcroft Gault formula).
- ECOG PS score 0-2.
- Life expectancy \> 3 months.
- Sign written informed consent.
- Willing and able to be followed up until death or end of study or study termination.
- Primary right-sided mCRC.
- dMMR/MSI-H mCRC.
- Patients with initial RAS wild-type or BRAF mutant mCRC.
- ctDNA testing shows that RAS or BRAF gene is mutant mCRC after second-line therapy.
- Serious arterial embolism or ascites.
- Serious bleeding tendency or coagulation disorder.
- Serious uncontrolled systemic complications such as infection or diabetes.
- Clinically significant cardiovascular disease such as cerebrovascular accident (within 6 months prior to enrollment), myocardial infarction (within 6 months prior to enrollment), uncontrolled hypertension despite...
- History or physical evidence of central nervous system disease (e.g., primary brain tumor, epilepsy uncontrolled by standard of care, any history of brain metastases or stroke).
- Other malignancies (except cutaneous basal cell carcinoma and/or cervical carcinoma in situ of the cervix and/or thyroid carcinoma after radical surgery) within the past 5 years.
- Hypersensitivity to any drug in the study.
- Pregnant and lactating women.
- Women of childbearing age (\< 2 years after last menstruation) or men of fertile potential who are not using or refuse to use effective non-hormonal contraception (intrauterine contraceptive ring, barrier contraceptives...
- Unable or unwilling to comply with the study protocol.
- Patients with any other diseases, dysfunction caused by metastatic lesions, or suspected disease found by physical examination, indicating possible contraindications to the use of the investigational drug or putting the...
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, 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.