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Tests treatment safety and results for Colorectal Neoplasms
Official title The Safety and Efficacy of Cetuximab Beta Plus Fruquintinib With or Without Immune Checkpoint Inhibitorrs in First-line Treatment of RAS/BRAF Wild Type Unresectable Metastatic Colorectal Cancer
ClinicalTrials.gov ID: NCT07257653
What this study is testing
What is Cetuximab β；Fruquintinib；?
Cetuximab β；Fruquintinib； is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for colorectal neoplasms.
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
- Colorectal cancer is a malignant tumor ranking among the top four in incidence and the top three in causes of death globally . Chemotherapy combined with anti-EGFR or anti-VEGF monoclonal antibodies is currently the standard first-line treatment for advanced pMMR colorectal cancer.
- 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 10 to 85
You may be able to join if
- 1）people voluntarily join this study, sign the informed consent form, and demonstrate good compliance; 2) Age: 10-80 years old, ECOG PS score of 0-1...
- Hematological examination standards (no blood transfusion or use of hematopoietic growth factors for correction within 7 days prior to screening):
- Hemoglobin (HGB) ≥ 90 g/L;
- Absolute neutrophil count (NEUT) ≥ 1.5 × 10⁹/L;
- Platelet count (PLT) ≥ 75 × 10⁹/L;
You likely can't join if
- Presence of MSI-H/dMMR patients.
- Concurrent diseases and medical history:
- Diagnosis of or concurrent other malignancies within the past 3 years. The following conditions are eligible for enrollment: Cured cervical carcinoma...
- Multiple factors affecting oral medication (e.g., inability to swallow, chronic diarrhea, intestinal obstruction, etc.);
- History or tendency of gastrointestinal bleeding or perforation within 4 weeks prior to enrollment;
- Patients with active inflammatory bowel disease within 4 weeks prior to enrollment;
See the full eligibility criteria
Who can join
- 1）people voluntarily join this study, sign the informed consent form, and demonstrate good compliance; 2) Age: 10-80 years old, ECOG PS score of 0-1. For patients aged 80-85, comprehensive functional assessments must be...
- Hematological examination standards (no blood transfusion or use of hematopoietic growth factors for correction within 7 days prior to screening):
- Hemoglobin (HGB) ≥ 90 g/L;
- Absolute neutrophil count (NEUT) ≥ 1.5 × 10⁹/L;
- Platelet count (PLT) ≥ 75 × 10⁹/L;
- Biochemical tests must meet the following criteria:
- Total bilirubin (TBIL) ≤ 1.5 × ULN (≤ 3 × ULN for people with Gilbert's syndrome);
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN. If with liver metastases, ALT and AST ≤ 5 × ULN;
- Serum creatinine (CR) ≤ 1.5 × ULN or creatinine clearance rate (CCR) ≥ 50 ml/min.
- Coagulation function 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 therapy);
- Thyroid-stimulating hormone (TSH) ≤ ULN; if abnormal, T3 and T4 levels should be assessed (FT3 and FT4 may be substituted if T3/T4 are unavailable at the center). people may be enrolled if T3 and T4 levels are normal.
- Echocardiogram assessment: Left ventricular ejection fraction (LVEF) ≥ 50%.
- Hepatitis B surface antigen (HBsAg) negative. If HBsAg positive, hepatitis B virus deoxyribonucleic acid (HBV-DNA) must be \< 2500 copies/mL or 500 IU/mL for enrollment.
- HCV antibody negative or HCV-RNA negative people may enroll; if HCV-RNA positive, people must have alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN to enroll. people with co-infection of...
- Female patients must meet one of the following conditions:
- Postmenopausal (defined as no menses for at least 1 year, with no other confirmed causes besides menopause), or
- Surgically sterilized (removal of ovaries and/or uterus), or
- Of childbearing potential but must meet the following:
- Serum/urine pregnancy test within 7 days prior to enrollment must be negative;
- Agree to use contraception with a failure rate of \< 1% per year or maintain abstinence (avoiding heterosexual intercourse) (from signing the ICF until at least 6 months after the last dose of the study drug)...
- Must not be breastfeeding.
- Male patients must meet the following: Agree to abstinence (avoiding heterosexual intercourse) or use contraception, as specified: When the partner is a woman of childbearing potential or is pregnant, the male patient...
What rules you out
- Presence of MSI-H/dMMR patients.
- Concurrent diseases and medical history:
- Diagnosis of or concurrent other malignancies within the past 3 years. The following conditions are eligible for enrollment: Cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta...
- Multiple factors affecting oral medication (e.g., inability to swallow, chronic diarrhea, intestinal obstruction, etc.);
- History or tendency of gastrointestinal bleeding or perforation within 4 weeks prior to enrollment;
- Patients with active inflammatory bowel disease within 4 weeks prior to enrollment;
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
- Unresolved toxicities from any prior antitumor therapy exceeding CTCAE Grade 1 (excluding alopecia and oxaliplatin-induced neurotoxicity ≤ Grade 2);
- Major surgical treatment, incisional biopsy, or significant traumatic injury within 28 days prior to the start of study treatment (excluding gastrointestinal endoscopic biopsy);
- Symptoms of active bleeding within 1 week prior to screening, without significant improvement or control;
- Patients with any bleeding event ≥ CTCAE Grade 3 within 4 weeks prior to study initiation, or presence of unhealed wounds, ulcers, or fractures;
- Arterial/venous thrombotic events within 6 months, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism;
- History of psychoactive drug abuse with inability to abstain;
- Patients with any severe and/or uncontrolled diseases, including:
- Uncontrolled hypertension (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg after standard antihypertensive therapy);
- Myocardial ischemia ≥ Grade 2, myocardial infarction, arrhythmias (including QTc ≥450 ms for males, QTc ≥470 ms for females), and congestive heart failure ≥ Grade 2 (New York Heart Association (NYHA) classification);
- Active or uncontrolled severe infections (≥ CTCAE Grade 2 infection);
- Liver cirrhosis, active hepatitis\ ; (\ Active hepatitis [Hepatitis B reference: HBsAg positive and HBV DNA positive (\>2500 copies/mL or \>500 IU/mL); Hepatitis C reference: HCV antibody positive and HCV viral titer...
- Renal failure requiring hemodialysis or peritoneal dialysis;
- History of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency diseases, or history of organ transplantation;
- Poorly controlled diabetes (fasting blood glucose \>10 mmol/L);
- Urinalysis showing urine protein ≥++ and confirmed 24-hour urine protein quantification \>1.0 g;
- History of clear neurological or psychiatric disorders, including epilepsy or dementia requiring treatment.
- Patients with known active or suspected autoimmune diseases. Patients with immune-related hypothyroidism requiring thyroid hormone replacement therapy and well-controlled type I diabetes are allowed. Patients with...
- Receipt of live vaccines within 28 days prior to enrollment. However, inactivated viral vaccines for seasonal influenza are permitted, while live attenuated influenza vaccines administered intranasally are not allowed.
- Patients requiring systemic glucocorticoids (\>10 mg/day prednisone equivalent) or other immunosuppressive drugs within 14 days prior to enrollment or during the study. The following conditions are allowed for...
- Use of topical or inhaled glucocorticoids in the absence of active autoimmune diseases;
- Adrenal glucocorticoid replacement therapy at doses ≤10 mg/day prednisone equivalent.
- Participation in other clinical studies or initiation of study treatment within 14 days after the end of prior clinical study treatment. History of severe allergy to any monoclonal antibody.
- Tumor-related symptoms and treatment:
- Surgery (excluding prior diagnostic biopsies), radiotherapy, chemotherapy, or other anticancer therapies within 4 weeks prior to the start of study treatment (calculated from the end date of the last treatment as the...
- Prior postoperative adjuvant therapy containing anti-angiogenic targeted drugs (including bevacizumab, cetuximab, panitumumab, aflibercept, regorafenib, etc.); d) Patients with symptomatic brain metastases or those...
- Patients deemed by the investigator to have concomitant diseases that seriously endanger subject safety or affect study completion, or who are otherwise considered unsuitable for enrollment.
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, 10 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.