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New treatment option for Metastatic Colorectal Cancer
Official title Sintilimab in Combination with Cetuximab and Chemotherapy As First-line Treatment for RAS/BRAF Wild-type Advanced Colorectal Cancer
ClinicalTrials.gov ID: NCT06776757
What this study is testing
What is Sintilimab+Cetuximab+Chemotherapy (mFOLFOX6/FOLFIRI/CAPEOX/CAPIRI)?
Sintilimab+Cetuximab+Chemotherapy (mFOLFOX6/FOLFIRI/CAPEOX/CAPIRI) is an investigational medicine, being studied as a potential treatment for metastatic 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
- In 2018, global cancer incidence reached 18.1 million new cases, with 9.6 million cancer-related deaths. Colorectal cancer ranked as the third most common malignancy by incidence.
- 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 75
You may be able to join if
- 1.Sign a written informed consent before implementing any trial-related procedures. 2.Age between 18 and 75 years old. 3.No gender restrictions...
- .Neutrophil Absolute Count (ANC) ≥ 1.5 x 10\^9/L, provided that granulocyte colony-stimulating factor has not been used in the past 14 days.
- .Platelet count ≥ 90 x 10\^9/L, provided that no blood transfusion has been received in the past 14 days.
- .Hemoglobin \> 9 g/dL, provided that no blood transfusion or erythropoiesis-stimulating agents have been used in the past 14 days.
- .Total bilirubin ≤ 1.5× Upper Limit of Normal (ULN); or total bilirubin \> ULN but direct bilirubin ≤ ULN.
You likely can't join if
- Previously received chemotherapy, cetuximab, or other anti-EGFR targeted therapies;
- Previously received any of the following therapies: anti-PD-L1, anti-PD-L2 drugs, or drugs targeting other stimulatory or co-inhibitory T cell...
- Symptomatic or high-risk conditions such as obstruction, bleeding, perforation, pneumonia (including non-infectious pneumonia treated with...
- Diagnosed with other malignant diseases outside of colorectal cancer within 5 years prior to the first dose (excluding surgically cured basal cell...
- Currently participating in an treatment clinical trial or received other investigational drugs or devices within 4 weeks prior to the first dose;
- Received traditional Chinese medicine with antitumor indications or immune-regulating drugs (including thymosin, interferons, interleukins, excluding...
See the full eligibility criteria
Who can join
- 1.Sign a written informed consent before implementing any trial-related procedures. 2.Age between 18 and 75 years old. 3.No gender restrictions. 4.Histologically or cytologically confirmed inoperable or recurrent...
- .Neutrophil Absolute Count (ANC) ≥ 1.5 x 10\^9/L, provided that granulocyte colony-stimulating factor has not been used in the past 14 days.
- .Platelet count ≥ 90 x 10\^9/L, provided that no blood transfusion has been received in the past 14 days.
- .Hemoglobin \> 9 g/dL, provided that no blood transfusion or erythropoiesis-stimulating agents have been used in the past 14 days.
- .Total bilirubin ≤ 1.5× Upper Limit of Normal (ULN); or total bilirubin \> ULN but direct bilirubin ≤ ULN.
- .Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5× ULN (patients with liver metastasis are allowed to have ALT or AST ≤ ULN).
- .Serum creatinine ≤ 1.5× ULN, and creatinine clearance (calculated using the Cockcroft-Gault formula) ≥ 60 ml/min.
- .Normal coagulation function, defined as International Normalized Ratio (INR) or prothrombin time (PT) ≤ 1.5× ULN.
- .Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range. If baseline TSH is outside the normal range, people with normal total T3 (or FT3) and FT4 levels may also be included.
- .Normal myocardial enzyme levels (people with isolated laboratory abnormalities that the investigator determines to have no clinical significance may still be eligible for inclusion). (Optional) 12.For female people of...
What rules you out
- Previously received chemotherapy, cetuximab, or other anti-EGFR targeted therapies;
- Previously received any of the following therapies: anti-PD-L1, anti-PD-L2 drugs, or drugs targeting other stimulatory or co-inhibitory T cell receptors (e.g., CTLA-4, OX-40, CD137) (adjustable);
- Symptomatic or high-risk conditions such as obstruction, bleeding, perforation, pneumonia (including non-infectious pneumonia treated with corticosteroids or ongoing pneumonia treatment);
- Diagnosed with other malignant diseases outside of colorectal cancer within 5 years prior to the first dose (excluding surgically cured basal cell carcinoma, squamous cell carcinoma of the skin, and/or surgically...
- Currently participating in an treatment clinical trial or received other investigational drugs or devices within 4 weeks prior to the first dose;
- Received traditional Chinese medicine with antitumor indications or immune-regulating drugs (including thymosin, interferons, interleukins, excluding local use for pleural effusion) as systemic therapy within 2 weeks...
- Experienced an active autoimmune disease requiring systemic treatment (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapies (e.g., thyroid...
- Receiving systemic corticosteroid therapy (excluding nasal, inhaled, or other forms of localized corticosteroids) or any other form of immunosuppressive therapy within 7 days prior to the first dose of the study drug...
- Received blood transfusion within 7 days prior to the first dose of treatment;
- Clinically uncontrolled pleural or peritoneal effusion (patients who do not require drainage or have stable effusion for 3 days after stopping drainage may be enrolled);
- Known history of allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
- Known allergy to the study drug, sindilizumab, chemotherapy, targeted drug active ingredients, or excipients;
- Presence of multiple factors affecting oral drug absorption (e.g., difficulty swallowing, post-gastrointestinal resection, chronic diarrhea, intestinal obstruction, etc.);
- Not fully recovered from toxicity and/or complications caused by any previous interventions before starting treatment (i.e., ≤ Grade 1 or back to baseline, excluding fatigue or alopecia);
- Known history of HIV infection (i.e., HIV 1/2 antibody positive).
- Untreated active hepatitis B (defined as HBsAg positive with detectable HBV-DNA copy numbers greater than the normal value upper limit in the testing laboratory of the research center); Note: Hepatitis B patients who...
- .Significant and symptomatic abnormalities in rhythm, conduction, or morphology on resting electrocardiogram that are difficult to control, such as complete left bundle branch block, second-degree or higher heart block...
- .Unstable angina, congestive heart failure, or chronic heart failure with New York Heart Association (NYHA) classification ≥ 2.
- .History of any arterial thrombosis, embolism, or ischemia within 6 months prior to enrollment, such as myocardial infarction, unstable angina, cerebrovascular accidents, or transient ischemic attacks (TIA), etc.;
- .Poorly controlled blood pressure (systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg);
- .History of non-infectious pneumonia requiring corticosteroid treatment within 1 year prior to the first dose, or currently has clinically active interstitial lung disease;
- .Active pulmonary tuberculosis;
- .Presence of active or uncontrolled infections requiring systemic treatment;
- .Presence of clinically active diverticulitis, intra-abdominal abscess, or gastrointestinal obstruction;
- .Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis;
- .Poorly controlled diabetes (fasting blood glucose (FBG) \> 10 mmol/L);
- .Urinalysis showing urine protein ≥ ++, and confirmed 24-hour urine protein quantification \> 1.0 g;
- .Presence of psychiatric disorders that prevent the patient from cooperating with the treatment; 21.A history or evidence of diseases that may interfere with the trial results, hinder the subject's full participation in...
The study team makes the final eligibility decision.
Where it's taking place
- Shenzhen, Guangdong, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shenzhen, 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.