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New treatment option for Metastatic Colorectal Cancer
Official title Cetuximab and Envafolimab Plus mFOLFOXIRI as First-line Treatment for RAS/BRAF Wild-type, MSS, Unresectable Left-side Metastatic Colorectal Cancer
ClinicalTrials.gov ID: NCT05959356
What this study is testing
What is Cetuximab + Envafolimab + mFOLFOXIRI?
Cetuximab + Envafolimab + mFOLFOXIRI is an investigational medicine, being studied as a potential treatment for metastatic colorectal cancer.
Also referred to as Cetuximab or c225, Envafolimab.
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
- The primary aim of phase II CEIL study is to evaluate the efficacy of cetuximab and envafolimab plus mFOLFOXIRI versus cetuximab plus mFOLFOX6 as first line treatment of patients with initially unresectable and previously untreated RAS/BRAF wild-type, MSS, left-side metastatic colorectal cancer(mCRC), in terms of Progression-free Survival.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
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
- Signed informed consent obtained before any study specific procedures. people must be able to understand and willing to sign a written informed...
- Male or female people ≥ 18 years, expected lifespan ≥ 12 weeks.
- Patients have histologically or cytologically confirmed RAS and BRAF wild-type, MSS metastatic colorectal adenocarcinoma (mCRC), excluding...
- AJCC/UICC stage IV left-side metastatic colorectal cancer. At least one measurable lesion according to RECIST 1.1.
- The patient has not previously received any systemic treatment specifically targeting advanced or metastatic colorectal cancer, including...
You likely can't join if
- Concurrent active malignancy, excluding malignancies with disease-free survival of 5 years or more or in situ carcinoma considered cured after...
- Currently diagnosed with gastrointestinal diseases such as duodenal ulcer, ulcerative colitis, intestinal obstruction, or other conditions determined...
- Experienced thrombotic or embolic events, such as cerebrovascular accidents (including transient ischemic attacks), pulmonary embolism, or deep vein...
- Experienced the following conditions within the 12 months prior to study enrollment: myocardial infarction, severe/unstable angina pectoris, New York...
- Use of systemic antibiotics for ≥7 days within the 4 weeks prior to study enrollment, or the occurrence of unexplained fever (\>38.5°C) during the...
- Presence of uncontrolled pleural effusion, ascites, or pericardial effusion within 14 days prior to study enrollment despite appropriate treatment.
See the full eligibility criteria
- Signed informed consent obtained before any study specific procedures. people must be able to understand and willing to sign a written informed consent.
- Male or female people ≥ 18 years, expected lifespan ≥ 12 weeks.
- Patients have histologically or cytologically confirmed RAS and BRAF wild-type, MSS metastatic colorectal adenocarcinoma (mCRC), excluding appendiceal and anal cancers.
- AJCC/UICC stage IV left-side metastatic colorectal cancer. At least one measurable lesion according to RECIST 1.1.
- The patient has not previously received any systemic treatment specifically targeting advanced or metastatic colorectal cancer, including chemotherapy, monoclonal antibodies such as cetuximab or panitumumab targeting...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Within 7 days before treatment, the following laboratory test values are obtained and appropriate organ function is present: Hemoglobin ≥ 90g/L, neutrophil count ≥ 1.5 × 10\^9/L, platelet count ≥ 75 × 10\^9/L; Serum...
- Women of childbearing potential must have a negative blood pregnancy test at the baseline visit. For this trial, women of childbearing potential are defined as all women after puberty, unless they are postmenopausal for...
- Patients are not allowed to participate in other clinical trials during the study period and willing to comply with the study protocol and visit plan.
- Concurrent active malignancy, excluding malignancies with disease-free survival of 5 years or more or in situ carcinoma considered cured after adequate treatment.
- Currently diagnosed with gastrointestinal diseases such as duodenal ulcer, ulcerative colitis, intestinal obstruction, or other conditions determined by the investigator to potentially cause gastrointestinal bleeding or...
- Experienced thrombotic or embolic events, such as cerebrovascular accidents (including transient ischemic attacks), pulmonary embolism, or deep vein thrombosis, within the 12 months prior to study enrollment.
- Experienced the following conditions within the 12 months prior to study enrollment: myocardial infarction, severe/unstable angina pectoris, New York Heart Association (NYHA) class II or above heart failure, clinically...
- Use of systemic antibiotics for ≥7 days within the 4 weeks prior to study enrollment, or the occurrence of unexplained fever (\>38.5°C) during the screening period/prior to the first dose (fever attributed to the tumor...
- Presence of uncontrolled pleural effusion, ascites, or pericardial effusion within 14 days prior to study enrollment despite appropriate treatment.
- Presence of any unresolved adverse events of Grade 2 or higher (excluding anemia, alopecia, and skin pigmentation) attributed to previous treatments according to the National Cancer Institute Common Terminology Criteria...
- Presence of interstitial lung disease, non-infectious pneumonia, or uncontrolled systemic diseases (e.g., diabetes, hypertension, pulmonary fibrosis, and acute pneumonia).
- Known human immunodeficiency virus (HIV) infection or known active hepatitis (defined as HBV-DNA ≥ 500 IU/ml for hepatitis B, and HCV-RNA above the limit of detection for hepatitis C) or co-infection with hepatitis B...
- History of known or suspected allergy to any investigational drug used in the study.
- Pregnancy or lactation in women.
- Pre-menopausal women (last menstrual period \<2 years ago) who do not use or refuse to use effective non-hormonal contraception, or fertile men.
- Presence of other significant physical or mental illnesses or laboratory abnormalities that may increase the risk of participation in the study, interfere with study results, or are deemed unsuitable for participation...
The study team makes the final eligibility decision.
Where it's taking place
- Foshan, Guangdong, China
- Guangzhou, Guangdong, China
- Guiyang, Guizhou, 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 Foshan, Guangdong, China; Guangzhou, Guangdong, China; Guiyang, Guizhou, 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.