Cetuximab in Combination With Anti-PD-1 and mFOLFOX Treat For RAS/BRAF wt Right-Sided Colon Cancer

Launched by TONGJI HOSPITAL · Jul 19, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with certain types of right-sided colon cancer, specifically those whose cancer has specific genetic markers (known as RAS/BRAF wild-type). The treatment combines three drugs: cetuximab, an anti-PD-1 medication, and mFOLFOX6, which is a chemotherapy regimen. The goal is to see how effective and safe this combination is for patients with locally advanced or metastatic (spreading) right colon cancer.

To participate in this trial, patients must have been diagnosed with right colon adenocarcinoma and have specific characteristics, such as having a tumor that is locally advanced or has spread to a limited number of organs. Eligible participants should also be between the ages of 18 and 75, have adequate organ function, and be able to provide informed consent. Those who have recently received other cancer treatments or have certain medical conditions may not qualify. Participants in the trial can expect regular monitoring and follow-up to assess the effectiveness of the treatment and manage any side effects.

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Eligibility criteria

• Inclusion Criteria:
• • 1. RAS and BARF wild-type right colon adenocarcinoma (cecum, ascending colon, transverse colon excluding splenic flexure) confirmed by histopathology;
• • 2. Locally advanced right colon cancer should be assessed as T3 (invading muscularis propria ≥5mm) or T4 according to abdominal CT;
• • 3. Metastatic right colon cancer should conforms to the definition of oligometastasis of colorectal cancer in ESMO guidelines: the number of organs involved is ≤2 (occasionally 3), and the number of metastases is usually ≤5 or occasionally more.
• • 4. At least one measurable lesion according to RECIST1.1;
• • 5. ECOG score 0-1;
• • 6. The expected survival time is more than 3 months;
• • 7. Adequate organ function: total bilirubin ≤1.5 x upper limit of normal (ULN) , aspartate aminotransferase and alanine aminotransferase ≤2.5 x ULN (if patient with liver metastasis, total bilirubin ≤3 x ULN, aminotransferase and alanine aminotransferase ≤5x ULN) ,alkaline phosphatase ≤2.5 x ULN (if liver metastases≤5x ULN, if bone metastases ≤10 x ULN);LDH \< 1500 U/L;Serum creatinine≤1.5 x ULN l or creatinine clearance rate ≤ 60 mL /min;ANC≥1.5×109 /L, platelet count ≥75×109 /L, Hb ≥90 g/L, WBC ≥3.0×109 /L;
• • 8. Capable of providing informed consent, or if not capable, a legally authorized representative is capable of providing informed consent.
• Exclusion Criteria:
• • 1.Early stage right colon cancer. 2. Received chemotherapy or biotherapy in the past . 3. uncontrollable infection, or received antibiotic treatment within 72 hours prior to receive chemotherapy; 4. Myelodysplastic syndrome or other hematopoietic abnormalities; 5. Other malignant tumors (except carcinoma in situ and basal cell carcinoma) during this year; 6. Patients with central nervous system metastasis; 7.≥ CTCAE Grade 2 unrecovered AEs due to prior treatment (excluding anemia, hair loss, skin pigmentation).Patients with unrecovered neurotoxicity ≥ CTCAE grade 3 due to platinum-based drugs.
• • 8. Other diseases, such as active tuberculosis, infect HIV, AIDS, hepatitis B (patient withHBV-DNA \<500IU/ml,and normal liver function can be included), positive test for hepatitis C virus, uncorrectable electrolyte disorder;ascites, pleural effusion or hydropericardium that required drainage in the past 4 weeks.With intestinal obstruction, gastrointestinal bleeding, pulmonary fibrosis or interstitial pneumonia, renal failure, hepatic failure , or cerebrovascular disease.
• • 9. Uncontrolled diabetes was defined as HbA1c \>7.5% after the use of antidiabetic drugs, or uncontrolled hypertension was defined as systolic/diastolic blood pressure \>140/90 mmHg after the use of antihypertensive drugs.
• • 10. Myocardial infarction,severe/unstable angina, NYHA III or IV congestive heart failure within the past 12 months.
• • 11. Patients who are allergic to the therapeutic drugs in this study; 12. With mental or nervous system diseases who are unable to cooperate; 13. Pregnant or lactating women;Childbearing age women refuse to accept contraceptive measures; 14.Active autoimmune disease, a history of autoimmune disease, accepting corticosteroid or immunosuppressants, or accepting hormone replacement therapy (such as thyroxine, insulin, etc).
• • 15. Received live vaccine within 30 days (seasonal influenza vaccine is allowed because it is inactivated) 16.Treated with any other investigational drug or participated in another interventional clinical trial within 30 days of the screening period; undergo surgery within 30 days (except for diagnostic biopsy, surgical incision should be completely healed prior to administration of the study drug).Received radiation therapy within 30 days.
• • 17. Other serious medical conditions made the investigator consider the patients ineligible for inclusion.