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New treatment option for Colorectal Cancer
Official title Neoadjuvant Treatment of Fulzerasib Plus Cetuximab N01 in KRAS G12C Mutated Locally Advanced Colorectal Cancer With or Without Resectable Metastases
ClinicalTrials.gov ID: NCT07581912
What this study is testing
What is fulzerasib; cetuximab N01?
fulzerasib; cetuximab N01 is an investigational medicine, given as a monthly infusion into a vein, being studied as a potential treatment for 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
- Background：KRAS mutations are the most common genetic alterations in colorectal cancer (CRC), associated with aggressive tumor biology and poor prognosis. For metastatic CRC harboring KRAS mutations, first-line standard treatment is chemotherapy plus bevacizumab.
- 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 85
You may be able to join if
- The people voluntarily joined this study, signed an informed consent form, and showed good compliance;
- Age: 18-80 years old, PS score 0-1;
- Colorectal adenocarcinoma diagnosed by histopathology, preoperative staging: T4N0-2M0, T3N2M0, T0-4N0-2M1a (with metastatic lesions present...
- Locally advanced colorectal cancer requires initial diagnosis of patients who have not received systematic treatment in the past. Patients with...
- The main organ functions well and meets the following criteria:
You likely can't join if
- Those who meet any of the following criteria will not be included in this trial:
- Patients with MSI-H/dMMR present;
- Patients with multiple metastases that cannot be resected;
- Combined diseases and medical history:
- Has had or is currently suffering from other malignant tumors within the past 3 years. The following situations can be included in the group: Cured...
- Patients with active inflammatory bowel disease within the first 4 weeks of enrollment;
See the full eligibility criteria
- The people voluntarily joined this study, signed an informed consent form, and showed good compliance;
- Age: 18-80 years old, PS score 0-1;
- Colorectal adenocarcinoma diagnosed by histopathology, preoperative staging: T4N0-2M0, T3N2M0, T0-4N0-2M1a (with metastatic lesions present, requiring MDT evaluation as resectable); PMMR/MSS, KRAS G12C mutation, and...
- Locally advanced colorectal cancer requires initial diagnosis of patients who have not received systematic treatment in the past. Patients with resectable metastatic lesions are required to have not received targeted...
- The main organ functions well and meets the following criteria:
- Blood routine examination criteria (corrected for no blood transfusion or use of hematopoietic stimulating factor drugs within 7 days before screening): hemoglobin (HGB) ≥ 90g/L (if chronic anemia is caused by chronic...
- Biochemical tests must meet the following standards: total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN) (Gilbert syndrome people, ≤ 3 × ULN); alanine aminotransferase (ALT) and aspartate aminotransferase...
- Coagulation or thyroid function tests must meet the following criteria: prothrombin time (PT), activated partial thromboplastin time (APTT), international normalized ratio (INR) ≤ 1.5 × ULN (without anticoagulant...
- Cardiac ultrasound evaluation: Left ventricular ejection fraction (LVEF) ≥ 50%.
- Those who meet any of the following criteria will not be included in this trial:
- Patients with MSI-H/dMMR present;
- Patients with multiple metastases that cannot be resected;
- Combined diseases and medical history:
- Has had or is currently suffering from other malignant tumors within the past 3 years. The following situations can be included in the group: Cured cervical carcinoma in situ, non melanoma skin cancer, and superficial...
- Patients with active inflammatory bowel disease within the first 4 weeks of enrollment;
- Uncontrollable pleural effusion, pericardial effusion, or ascites that require repeated drainage;
- Unrelieved toxic reactions above CTCAE grade 1 caused by any previous anti-tumor treatment (excluding hair loss and ≤ grade 2 neurotoxicity caused by oxaliplatin);
- Within 4 weeks prior to the start of the study, any bleeding events ≥ CTCAE grade 3 occurred in patients with unhealed wounds, ulcers, or fractures;
- History of arterial/venous thrombotic events within 6 months, such as cerebrovascular accidents (including transient ischemic attacks, intracerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary...
- Individuals with a history of substance abuse involving psychotropic drugs who are unable to quit;
- people with any severe and/or uncontrolled diseases, including: uncontrolled hypertension (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg despite standard antihypertensive treatment); myocardial...
- Tumor-related symptoms and treatment: Previously received targeted drug therapy (including G12C inhibitors, bevacizumab, etc.);
- According to the investigator's judgment, people with serious diseases that pose a significant risk to their safety or affect the completion of the study, or those deemed ineligible for enrollment due to other reasons.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, 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 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, 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.